Digital Transformation Consulting Services

Configuration Management and System Administration

Zifo establishes and maintains a centralized Configuration Management Database (CMDB) to track all your IT assets and their configurations. This provides a clear and accurate view of your IT environment, ensuring consistency and compliance. Our expert system administrators handle routine maintenance, updates, and security patching, freeing up your internal teams.

Zifo’s meticulous approach to configuration management reduces the risk of errors and simplifies troubleshooting. We optimize system performance and ensure a stable and well-managed IT infrastructure supporting your scientific endeavors.

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System and Integration Monitoring/ Uptime Management

Zifo provides comprehensive 24/7 monitoring of your critical scientific applications, systems, and integrations. Our proactive approach detects potential issues before they impact your operations, minimizing downtime. We leverage advanced monitoring tools and our deep understanding of scientific workflows to ensure high system availability and smooth data flow between integrated platforms.

Zifo’s rapid response and remediation capabilities ensure business continuity, allowing your scientists to access the tools they need, when they need them, without interruption.

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Service Level Management

Zifo partners with you to define clear and measurable Service Level Agreements (SLAs) aligned with your business needs. We help establish performance targets for critical IT services supporting your scientific applications. Our monitoring and reporting capabilities track service delivery against these agreed-upon levels, providing transparency and accountability.

Zifo proactively identifies potential SLA breaches and implements corrective actions. We are committed to ensuring your IT services consistently meet expectations, driving user satisfaction and supporting your scientific objectives.

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Problem Management

Zifo’s proactive problem management focuses on identifying and eliminating the root causes of recurring issues. Our experienced team conducts thorough root cause analysis, leveraging industry best practices and scientific application knowledge. We develop and implement permanent fixes, preventing future incidents and improving overall system reliability.

Zifo establishes efficient workflows for problem identification, investigation, and resolution. This reduces downtime, enhances end-user productivity, and ensures a stable and dependable scientific application environment.

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Change Management

Zifo helps you streamline IT changes with a structured and controlled approach. We implement robust change management processes, including impact assessments, risk analysis, and approval workflows, minimizing the potential for disruptions. Our expertise ensures smooth transitions during upgrades, deployments, and modifications.

Zifo provides clear communication and documentation throughout the change lifecycle. We help you maintain a stable environment by proactively managing changes and reducing the risk of unexpected incidents, allowing your scientific operations to continue without interruption.

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Cloud Managed Services

Ensuring enterprise applications and systems are “always on” and end-users are supported with their issues and help requests is a critical endeavor of IT departments. Zifo has proven scale, quality, processes and application knowledge that can reduce the burden of your scientific application management.

Our processes and use of industry-standard approaches such as ITIL can have a measurable impact on end-user efficiency, satisfaction and reduced application downtime.

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Laboratory Instrument, Sensor Data and System Integration

Scientific informatics systems typically need to be integrated into the lab and other systems to deliver the most value to the users and to streamline reference data from ERP, registration and inventory for example. Labs very often also require systems, like ELN and LIMS, integration with laboratory instruments — from simple balances and pH meters to HPLC and NMR instruments and their associated software.

Zifo’s experience is both broad and deep and we have project planning & lab audit tools alongside extensive integration layer technology experience, instrument data standards (ADF, AniML, SiLA etc.) and tech blueprints to help accelerate your integration projects.

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Live Chat Support Services

Ensuring a smooth and successful rollout of new software and hardware is a critical step of informatics projects and requires focus, flexibility and experience. As projects near Go Live, the emphasis changes from planning and technical configuration to training, user support and hyper care of early adopters. Once into Go-Live, the emphasis becomes learning, scale and building a knowledge base of help and support of the ongoing use of the systems.

Zifo has experience in very large, global, multisite lab rollouts and smaller, focused, single lab group rollouts – but we bring the same focus on quality, user satisfaction and responsiveness to all projects.

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Scientific Technology and IT Help Desk

Zifo provides full end-user support desk provision and combines expert science with extensive scientific software and systems understanding with the process and scaling to ensure end-user satisfaction. Our support services cover early user training as part of project delivery, then onto hyper care during early roll-out, then onto BAU support and knowledge base creation to feedback into ongoing training to reduce help desk tickets and upskill users.

Leveraging industry best practices such as ITIL and “follow the sun” support structures and combining those with our science and technology partnership collaborations to ensure end-users get the support they need.

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Ontology Development and Management

Zifo works with various standards and public ontologies including but not limited to BAO, Biopax, SBO, EFO, Biolink, GO, MONDO, OMIM, DRUGBANK, HGNT, NCIT, AFO, OBO, ADF, ADM, ISA-88, MIAME and more.

Our services include Custom Ontology Design, Ontology Extension and Integration, Governance Frameworks and Best Practices, Ontology Validation, Semantic Modeling and Data Mapping, Ongoing Maintenance and Version Management 

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FAIR Data & Scientific Data Architecture

We build and support scientific data architecture that spans the entire product lifecycle—designed to handle the complexity and diversity of biopharma data. From Omics & Molecular Data to Chemistry & Analytical, Preclinical & Bioassay, and CMC & Process Data, we ensure your data is standardized, integrated, and analytics-ready. We also support the seamless flow and governance of Clinical & Real-World Data, Translational and Manufacturing and Quality Data, enabling end-to-end traceability and smarter decision-making across R&D and operations.  

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Digital Transformation Strategy

We provide the Digital transformation strategies that are essential to get your business into the new digital era of AI-driven drug discovery. Our approach is designed to address every facet of your specialized business needs by utilizing our 3-pillar approach of Science, Technology, and Data, with People at the core.

At Zifo, we have deep expertise at each of these pillars to provide an end-to-end support and results including developing a comprehensive Business Strategy for the entire organization to drive the Pipeline through work process changes and potential technology and process solutions at any stage of your journey.

Final Deliverables may include: Benchmarking analysis, Data governance strategy and implementation, FAIR data transformation, Data science and workflow orchestration, Data architecture, Product Configuration and implementation, Project and change management definition, etc.

digital-transformation-strategy

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Data Governance

Strong Data Governance is essential for a trusted data environment. It sets the rules and responsibilities for managing your data effectively, ensuring compliance and maximizing its value. Without it, data can become a liability.   

Zifo helps you implement tailored Data Governance frameworks. We assist in defining policies, roles, and processes to ensure your data is managed responsibly and strategically. Partner with Zifo to build a culture of data trust.

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Data Stewardship

Reliable data is crucial for accurate insights. Data Stewardship services include assisting Scientists capture the right data, contextualized with key metadata, mapping to Ontologies and Controlled Vocabularies defined.   

Zifo provides also provides Data Quality Monitoring solutions. We implement automated checks and alerts to ensure data accuracy, completeness, and reliability. Trust Zifo to maintain the integrity of your data.

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Change Management

Our change management approach looks at the engagement of stakeholders and end-users, through requirements and vision capture, decision making and consensus building, to communication planning and program success monitoring.

Zifo has expertise and experience in delivering enterprise change management programs and is well versed in the processes and techniques that can be used to ensure good adoption of change.

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Managed Services

LIMS managed services provide laboratories with ongoing monitoring, maintenance, support, upgrades, and optimization of their digital lab environments. By outsourcing LIMS management to a trusted scientific partner, laboratories can focus on core scientific and regulatory functions while ensuring their systems remain compliant, secure, and high performing.

Zifo’s managed services help minimize downtime, improve system responsiveness, and maintain adherence to critical standards such as FDA 21 CFR Part 11, ISO 17025, GLP, GMP, HIPAA, and GDPR. Sensitive lab data is protected through strong security and access controls, while infrastructure is continuously monitored and improved. Zifo eliminates the overhead of internal LIMS administration, enabling cost savings and operational agility — while delivering rapid issue resolution and long-term system reliability through, expert-led support.

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Tech Transfer

The efficient transfer of all the information that has been accumulated around a product and the process for its production process from research and development to manufacturing is a crucial step in a product’s lifecycle. Gathering the information and data, handover of analytical testing processes, manufacturing process parameters and product specification data whilst ensuring the data integrity is a time-consuming and detailed process.   

Zifo understands that successful technology transfer hinges on a well-orchestrated approach encompassing Process, Data, Organization, and Technology (PDOT). Zifo has domain experience and expertise with both technology providers and best practice processes to support your tech transfer and help dismantle data silos and foster a connected environment from early research to final product.

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Manufacturing Batch Release

Manufacturing batch release is a complex process that involves various informatics platforms and the application of strict business rules in most cases requires a lot of manual data transcription from ERP to LIMS, to CDS to Excel, back to ERP with tedious manual reviewing of all batch data to uncover non-conformities. The validation and QC of this process when suboptimal, manual, and human-centric is excessive and limits the scale and throughput of the process.   

Zifo works with companies to help understand the process, look at ways to streamline it and then apply technology and change management to remove many of the manual aspects and automate business rules to support decisions – meaning a fast, more scalable process and better-quality assurance.

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Compliance

Our LIMS validation ensures adherence to FDA 21 CFR Part 11, ISO 17025, GLP, GMP, HIPAA, and GAMP 5 requirements. We protect against data loss, unauthorized access, and errors, ensuring the integrity and security of your critical laboratory data. Our validation processes confirm that LIMS functions work as expected in real lab environments, ensuring consistent, reproducible workflows for sample management and reporting. We also ensure traceability of sample data, results, and approvals, always making your lab audit ready.

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Data Migration

Zifo leverages Gen AI and intelligent automation to accelerate mapping, transformation, and validation of complex laboratory data. This approach reduces manual intervention, detects anomalies early, and increases consistency — allowing migrations to be completed faster without compromising data integrity or regulatory requirements. Zifo supports a wide spectrum of data types, including sample/test records, instrument and calibration data, quality and compliance metadata, user roles, and historical logs.

Each migration is tailored to the lab’s context — whether single-site, multi-site, or cloud-based — and includes parallel system testing, encryption, validation, and audit-ready documentation to ensure a seamless and high-quality outcome.

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Data Analytics, Dashboards and Visualizations and Reporting services

Data analytics, Dashboards and Visualizations, and reporting capabilities within LIMS enable laboratories to convert raw data into actionable insights. By leveraging interactive dashboards, real-time analytics, and automated reporting, labs can improve data-driven decision-making, enhance regulatory compliance, and drive operational efficiency.

Zifo brings deep scientific knowledge and technical expertise in platforms like Power BI, Spotfire, to help labs unlock the full potential of their LIMS through scalable dashboard solutions, real-time analytics, and automated reporting — delivered with end-to-end support from design to deployment and training. Custom visualizations tailored to specific roles and workflows offer instant access to critical information — supporting continuous improvement and audit readiness.

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Instrument Integration

Zifo supports integration through multiple methods, including APIs, middleware platforms, and direct communication protocols such as RS-232, USB, and TCP/IP—tailored for both modern digital instruments and legacy devices. Zifo leverages solutions like Thermo Fisher Integration Manager, LabWare Instrument Gateway, and STARLIMS Advanced Analytics to enable scalable, vendor-specific middleware integrations. For instruments that output structured files (CSV, XML, JSON, Excel), Zifo enables automated file-based ingestion into LIMS systems.

In addition, Zifo supports IoT and cloud-based instrument integration, enabling real-time monitoring of lab conditions such as temperature, humidity, and pressure through sensor networks. These integrations empower remote access, AI-driven analytics, and predictive maintenance capabilities—enhancing the lab’s digital readiness.

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AI-Enabled Service Accelerator(qcKen)

By enabling faster data standardization and reducing manual errors, Zifo helps labs improve data quality while significantly reducing setup time.

Zifo’s hybrid delivery model combines AI-driven tools, process automation, and expert oversight to deliver predictable, high-quality outcomes. With experience across regulated domains such as pharma, biotech, clinical, and environmental labs, Zifo aligns master data structures to USP, GxP, and EU regulatory expectations while simplifying ongoing governance.

By consolidating core lab data and enabling automated search, filtering, and reporting, Zifo ensures master data is not just compliant — but a strategic asset driving lab performance.

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Master Data Management

Zifo helps lab users with its ability to review, adapt, and fill gaps in master data using contextual understanding of lab operations and compliance standards such as USP, GxP, and ISO 17025. The blend of the above capabilities significantly reduces the need for site involvement, while ensuring master data is clean, standardized, and audit ready.

Zifo also supports in validation of master data as part of LIMS implementations or upgrades—applying the same rigor and regulatory alignment to ensure the data structure is, traceable, and fit for purpose in regulated environments.

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Implementation

Zifo’s implementation services follow the EDGE Framework — Envision, Design, gain early wins, and Expand — to ensure purposeful, value-driven digital transformation.

Zifo begins by Envisioning the lab’s objectives, user needs, and expected outcomes to align implementation with strategic goals. In the Design phase, Zifo collaborates with lab users, IT, and business teams to drive adoption and manage change effectively.

With early wins established, Zifo helps customers expand the solution through structured, scalable rollout — ensuring long-term success and digital maturity.

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Consulting

Zifo’s consulting services are designed to guide organizations through their digital transformation journey — from vision to value realization. We start by helping customers define a clear digital roadmap, grounded in business objectives and scientific workflows. Our approach focuses on understanding the current landscape, identifying improvement opportunities, and prioritizing initiatives that deliver measurable impact.

With deep scientific expertise in pharma and biopharma, Zifo supports customers in evaluating the right technologies, aligning systems with processes, and designing scalable integration architectures. Whether it’s selecting a lab system, enabling data flow across platforms, or driving change management, we bring structured, product-agnostic guidance every step of the way.

Zifo remains a trusted partner throughout the transformation lifecycle — offering strategic input, solution validation, and operational support to ensure sustainable success.

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Quality and Compliance Consulting

Whether ensuring the quality of a product through assurance processes or adhering to regional regulatory organizations (FDA, EMA, Health Canada, DCGI, etc.) compliance frameworks like GLP, GCP, GMP, GMLP etc. the laboratory and testing environment in science is a complex area. Starting a new quality system from scratch or adapting/auditing one against new regulatory or quality requirements requires deep knowledge of the laboratory, science, regulations and quality approaches.

Zifo is a perfect partner to help your quality and compliance journey with many years and deep domain knowledge we can help avoid common pitfalls and wrong turns.

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Stability Studies

Assessing the shelf life and stability of products is crucial to product development and release. Planning studies to ensure the environmental and packaging variables are tested fully is paramount.

Zifo’s technology experience spans the entire stability study process, in both validated and non-validated environments, from study design (DoE) and planning, sample tracking and pull date scheduling, through environmental monitoring, sample testing and analytical test results capture, through to study results aggregation and statistical analysis.

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Technology Transfer Support Services

The efficient transfer of all the information that has been accumulated around a product and the process for its production process from research and development to manufacturing is a crucial step in a product’s lifecycle. Gathering the information and data, handover of analytical testing processes, manufacturing process parameters and product specification data whilst ensuring the data integrity is a time-consuming and detailed process.

Zifo has domain experience and expertise with both technology providers and best practice processes to support your tech transfer.

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Analytical Testing and Lab Services

Analytical test development and execution is ubiquitous in science-based organisations where information is needed to make decisions. The many facets of testing from assay development and validation, through instrument data acquisition and integration, regulatory and QC data reporting as COAs, test specifications, to lab inventory and metrology monitoring all require specialist informatics and hardware such as LIMS, LIS, CDS, Metrology, Inventory, Robotics etc.

Zifo has deep experience and expertise in delivering informatics solutions in the analytical testing ecosystem across many different market verticals and lab operations.

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CMC Services in Manufacturing

Chemistry, Manufacturing and Controls (CMC) is a critical part of the new therapy development pathway. As part of the FDA regulatory process for approval, it requires all information relating to a new product is collated – ranging from specifications, manufacturing process control parameters, stability parameters and analytical test variance data etc. Aggregating and ensuring the regulatory integrity of this information from the many different systems that hold it is a time consuming and complex task.

Zifo has regulatory expertise and technology partnerships that can reduce the burden of CMC and help speed up new product approval.

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Manufacturing Batch Release

Manufacturing batch release is a complex process that involves various informatics platforms and the application of strict business rules in most cases requires a lot of manual data transcription from ERP to LIMS, to CDS to Excel, back to ERP with tedious manual reviewing of all batch data to uncover non-conformities. The validation and QC of this process when suboptimal, manual and human-centric is excessive and limits the scale and throughput of the process.

Zifo works with companies to help understand the process, look at ways to streamline it and then apply technology and change management to remove many of the manual aspects and automate business rules to support decisions – meaning a fast, more scalable process and better-quality assurance.

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Business Process Automation Service

Huge benefits are possible with Process Automation and workflow orchestration in scientific informatics and processes. Whether automating high throughput screening with robotics in research, LIMS instrument integration in product development or automating manufacturing batch release processes between ERP, LIMS, CDS and application of business rules the efficiency impacts are often significant.

Zifo has expertise and experience in many areas of process automation and provides services and solutions based on open-source and proprietary software and robotics platforms. We have experience with various platforms and leverage BPMN and associated tools to deliver services and solutions.

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Ontology Development and Management

Ontologies are a foundation of FAIRification, data exploration and reuse in AI and ML. They are an extension of Master Data Management (MDM) taking taxonomies and vocabularies and adding a layer of context and real-world relationships to the data. Defining ontologies is not simple and requires a combination of deep scientific domain knowledge and data management understanding. Coupled with the definition is their ongoing management and governance to ensure the scientific and business needs are met.

Zifo has experience in ontology development and various commercial and open-source ontology definition and management platforms alongside deep domain and technical knowledge to support your FAIR and semantic data journey.

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Data Readiness for AI/ML

Getting the most from data requires extraction, transformation and piping to and from platforms both on-prem and in the cloud – data wrangling. During this ETL data is transformed to alternate formats and structures to support downstream consumption like loading to data lakes, data warehouses. There are many nuances to this process and no two projects are ever identical due to the variability of data source and end state data structures.

Zifo has experience with many “data wrangling” approaches, extraction automation and scaling, ETL tools, data formats and enrichment techniques that all support the data re-use and FAIR data journey.

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Data Modelling Consulting

We ensure compliance with the FAIR principles (Findable, Accessible, Interoperable, Reusable) while being mindful of data maturity and readiness.

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MLOps: Reliable, Scalable, Explainable ML

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Generative AI in Drug Discovery and Protein Engineering

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Data Readiness for AI/ML

From quality checks and normalization to feature engineering and data enrichment, Zifo prepares your data to drive impactful AI and ML outcomes.

We provide services such as:

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Scientific Expertise Domain

Our Scientific expertise domain spans from Discovery (e.g. Cell and Gene Therapy, NGS, Structural/Medicinal Chemistry, HTS and HCS), Pre-clinical Development (e.g. Biomarker and Metabolite analysis, DMPK, In vitro/in vivo Studies, Biologics development, Translational studies), Clinical Trials (e.g. Regulatory Submission Reporting (IND, NDA, BLA), SEND, CDISC, SDTM, ADAM standards 21 CFR Part 11, GLP, GCP, Clinical Supply & Clinical Sample Management, etc.) and Manufacturing (Digitation, QA, Knowledge maps, GxP).

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Digital Transformation

We provide the Digital transformation strategies that are essential to get your business into the new digital era of AI-driven drug discovery. Our approach is designed to address every facet of your specialized business needs by utilizing our 3-pillar approach of Science, Technology, and Data, with People at the core.

At Zifo, we have deep expertise at each of these pillars to provide an end-to-end support and results including developing a comprehensive Business Strategy for the entire organization to drive the Pipeline through work process changes and potential technology and process solutions at any stage of your journey.

Final Deliverables may include: Benchmarking analysis, Data governance strategy and implementation, FAIR data transformation, Data science and workflow orchestration, Data architecture, Product Configuration and implementation, Project and change management definition, etc.

Science Technology

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Business Systems Analysis

All our Business Analysts are scientists with lab experience and empathy, who truly understand the scientific workflows and pain points of transforming data into breakthroughs.

Our methodologies include: Business Process Mapping, Current and Future State visualizations, VoC and Gap Analysis reports, User and Functional Requirements Specifications, Data Governance and Management Strategies, Use Cases and User Stories, Data Flow Mapping and Data Modeling, FAIR Data Assessment, UATs, User adoption documentation and Training, etc.

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Platform Implementation, Change Management, and User Adoption

We provide an end-to-end service to meet your every need. We know that people are at the core of any successful change. Our change management approach is focused on engaging stakeholders and end-users by capturing their vision, understanding their processes and data needs, with empathic communication and program success monitoring.

Final results/deliverables may include: Development of Business Strategy for the entire R&D IT organization, 4R Analysis Report, VoC and User Requirements, Process Harmonization & System Standardization Opportunities Report, Project Management services, FAIR and Data Governance Opportunities Reports, Technical Configuration, Customization & Implementation of any scientific platform, DB and Server Configuration, Instrument integration/Lab automation services, UAT and Validation services, Training and Hypercare, and well as continued Application Support services.

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Platform Evaluation Decisions

We utilize our extensive methodology and solutions expertise in R&D Informatics of wide-range informatics technologies in a comprehensive vendor-agnostic, quantitative approach to decision-making. Our Product evaluation methodology includes Functional evaluation, Technical evaluation, GxP evaluation and Supplier evaluation, to bring a comprehensive solution to address your business need.

Following your selection of optimal technology solution, we offer a full Implementation Roadmap and Implementation Support, spanning from data governance transformation and technology adoption (e.g. server and DB architecture), to change management and user adoption & training.

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Strategic Roadmap and Market Research

At Zifo, we leverage our knowledge of industry best practices and experiences from 20+ years of engagements across pharma and biotech industries. Our long-standing vendor-agnostic provide optimal and customized solutions to your unique business needs.

Final deliverables may include: Industry Positioning and Best Practices; Business Process Recommendations; Standardization and Harmonization Opportunities; Technology and Digitalization Opportunities; Implementation Roadmap Solutions and Recommendations, Data strategy goals, Data harmonization, AI Readiness, etc.

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Optimizations and Extensions

Zifo’s CLEAR and LEI products boost lab efficiency and compliance. We understand lab workflows and tailor Empower configurations (custom fields, reports) to your needs, including validation.

CLEAR accelerates reviews by 70%, enhances documentation, and moves you toward a paperless lab. LEI simplifies bidirectional data exchange between LabX and Empower, minimizing errors and manual intervention.

As an Empower Toolkit application, LEI offers quick, intuitive implementation even for complex lab setups, often without requiring SOP changes. These future-proof solutions provide flexibility and efficiency for labs of any size.

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Data Integrity

Zifo ensures data correctness, completeness, and consistency through validated CDS system settings, comprehensive SOPs, and targeted training. We optimize system configurations for robust documentation and traceability, implementing user roles to enforce process adherence and prevent unauthorized actions.

Our SOPs detail all processes, including CDS application, administration, and review procedures. Training reinforces these processes, minimizing errors and unnecessary data generation. Consultants help reduce manual work by enabling direct CDS calculations and reporting, creating and validating custom fields and reports.

Our CLEAR extension for Empower enhances data security by guiding users through double-check and audit trail reviews, optimizing the process and providing paperless documentation. This comprehensive approach enables successful CDS implementation and operation, with options for optimizing individual areas.

Whether you’re updating an existing system or streamlining sample processing, Zifo offers cost-effective, high-quality solutions based on years of global CDS expertise.

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Support and Helpdesk

Incident Management: With 25+ years of CDS experience, Zifo supports your CDS implementation from planning and requirements gathering to testing and ongoing operation. We offer flexible integration, from project management support to fully managed services. 

Lab Support: Our comprehensive approach considers user, quality management, and IT perspectives, enabling support at all levels of your CDS installation. We collaborate with your IT, utilize your ticketing system, or work directly with your key users. 

Managed Services: Zifo’s Service Desk optimizes laboratory software operations, providing tailored solutions. We assist with Empower custom fields, reports, and project structuring. Our managed services deliver organized IT solutions for a defined period under a comprehensive contract.

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Validation

Our services encompass a comprehensive approach to system validation, beginning with thorough system analysis and risk assessment of your CDS-based processes. Based on this assessment, we develop detailed test plans and execute comprehensive tests to ensure system functionality and reliability. Finally, we deliver comprehensive documentation and reports covering all aspects of the validation process, ensuring compliance with regulatory requirements.

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Implementation (Rhizomer)

For large-scale Empower installations, Zifo’s Rhizomer 2.0 enables central management of LAC/E computers, eliminating on-site configuration. This reduces administrative workload, costs, and the need for on-site personnel. Updates are quick — typically 20 minutes –, minimizing downtime and boosting productivity.

Rhizomer facilitates rapid restoration in case of computer failure. Key features include rollback options, automatic change documentation, customizability, and configuration backup. It’s a future-proof solution designed for efficient lab management.

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Training and Workshops

Every laboratory has its own processes, objectives, and challenges — and thus, very individual training needs. As a leading provider of classroom training for Empower users, Zifo addresses this with specific training plans that optimally fit your laboratory’s requirements. We offer all our Empower training modules in German and English. Our training provides an optimal balance of theory and practice, suitable for beginners and system administrators alike.

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Medical Device Validation

Validation of Medical Devices involving Mobile Applications, Software-based, AI/ML-based devices is critical to gaining regulatory approval and marketing. Regulatory constraints are wide-reaching and deep knowledge and up to date awareness of Quality System Regulations (QSR), CSA/CSV process, and cybersecurity regulations are needed to ensure compliant medical devices. Zifo has extensive experience in this domain and experience with SaMD development and validation approaches.

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Testing and QA Services

Zifo provides comprehensive application testing services, including functional, performance, and security testing. We leverage test automation to streamline testing and accelerate delivery. Additionally, we conduct usability and accessibility testing to enhance user experience and ensure compliance with accessibility standards.

We also establish and manage Testing Centers of Excellence (TCoEs) to help organizations centralize testing capabilities, adopt best practices, and maximize testing efficiency. TCoEs enable consistent quality delivery across projects and drive continuous improvement through the adoption of advanced methodologies and tools.

Whether you need end-to-end testing services or specialized testing support, Zifo ensures that your systems meet operational, regulatory, and user expectations.

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Commissioning, Qualification and Validation (CQV)

Zifo provides comprehensive lab compliance support, from procurement to ongoing maintenance. We excel in validation, ensuring compliance with regulatory and customer requirements. Our expertise encompasses Data Integrity (DI) within GLP/GMP environments and robust documentation. We offer periodic compliance services, including reviews, audits, and CAPA support. Additionally, we specialize in Enterprise Application Validation, including SDLC Qualification, instrument integrations, and end-user training.

Zifo boasts years of CQV leadership in the GxP space, partnering with global pharma and biotech. We ensure regulatory compliance with deep knowledge of 21 CFR Part 11, EU Annex 11, and GAMP 5. Our ISO 9001:2015 and ISO 27001:2013 certified QMS supports successful FDA and EMA audits. We offer scalable CQV services with a focus on ownership and innovation, covering a wide range of laboratory instruments.

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Digital Validation and Assurance (CSV/CSA)

At Zifo, we bring extensive expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA), ensuring that computer systems work as intended and comply with regulatory standards. With proven experience across the life sciences domain, we specialize in delivering solutions tailored to meet the requirements of GLP, GCP, GMP and GMLP domains.

We provide end-to-end services, from devising the validation strategy and conducting risk assessments to executing validation activities, including IQ, OQ, PQ test script development, test execution, issue resolution and summary reporting. Our approach aligns with the latest CSA guidance, emphasizing a risk-based validation framework that prioritizes critical thinking over excessive documentation.

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IT Quality and Compliance Consultation

Our experts can help you with new quality system design, delivery, and maintenance; auditing against regional regulatory guidelines (21 CFR Part 11/EU Annex 11/Japanese ERES, HIPAA, GLP, GCP, GMP, GMLP, GDPR, QSR); quality system audits and recommendations; and quality system best practice adoption.

Zifo consultants engages with industry consortiums (RAPS, ISPE, Pistoia, KENX etc.) to stay ahead in regulatory advancements and implement agile, risk-based, and paperless validation strategies, including CSA and GMLP.

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AI Software Assurance

Implementation of AI/ML in GxP areas require strong understanding of Good Machine Learning Principles (GMLP) and concepts of AI/ML Validation. Zifo’s GxP AI Experts can help you design the quality framework for your AI journey with necessary creation of policies and procedures as well as help with building AI Software Assurance practice.

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Scientific Cloud and Enterprise Architecture

Our Scientific Cloud and Enterprise Architecture Consulting services empower life sciences organizations with scalable, secure, and cost-optimized cloud solutions on AWS, Azure, and GCP. We specialize in modernizing IT infrastructure, enhancing cloud security, and optimizing platforms for scientific workloads.

Key Capabilities:

Solution Architecture: Strategic cloud-native design for scientific computing.
Cloud Modernization: Seamless transition to scalable cloud environments.
Cloud Security: Proactive risk identification and compliance alignment.
DevSecOps and FinOps: Secure, cost-efficient operations with automated governance.
Observability: End-to-end visibility into cloud performance and security.
COTS Integration: Integrate commercial off-the-shelf solutions.
Platform Modernization: Upgrade legacy infrastructure to cloud-native architectures.

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High Performance Computing

Zifo’s Elastic HPC Solutions enable pharma and biotech to accelerate drug discovery, genomic research, and clinical simulations using scalable cloud clusters on AWS and Azure. We design blue-green, usage-aligned HPC architectures for high availability, cost efficiency, and performance.

Key Capabilities:

HPC Cluster Deployment: Automated deployment via Ansible for AWS ParallelCluster and Azure CycleCloud.
Job Management: Integration of Slurm, SGE, PBS, MPI and PsN with approval workflows.
Performance Optimization: Low-latency computing with InfiniBand, EFA, and Accelerated Networking.
Storage Solutions: Diverse storage options including AWS FSx Lustre, Azure NetApp Files, EBS, EFS, and S3.
Operations and Security: User access management, Linux administration, patching, monitoring, and compliance.
Utilization and Cost Management: Real-time dashboards for usage and resource optimization.

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Data and AI Compute Platforms

Our cloud-native Data and AI solutions empower pharma and biotech to accelerate drug discovery, optimize operations, and enhance real-time decision-making.

Key Capabilities:

Serverless AI/ML: Managed, event-driven machine learning without infrastructure.
Edge AI: Real-time AI processing at data sources for clinical and manufacturing.
Federated Learning: Privacy-preserving AI models trained across decentralized datasets.
Generative AI in Pharma: AI-driven drug discovery, preclinical simulations, and process optimization.
Quantum AI Exploration: Complex simulations and molecular modeling using AWS Braket, Azure Quantum, and Google Quantum AI.

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Compliance Cloud

Our Qualified Hosting Services provide validated, secure, and compliant cloud infrastructure on AWS and Azure for pharma, biotech, and other regulated industries. We ensure adherence to GxP, 21 CFR Part 11, HIPAA, and GDPR through automated deployment and continuous compliance.

Key Capabilities:

Validated Environments: Pre-configured compliance controls for AWS/Azure.
Infrastructure as Code: Automated, reproducible deployments with Terraform/Ansible.
Automated Deployment: CI/CD pipelines for scalable, validated infrastructure.
Continuous Compliance: Automated checks for GxP, ISO 27001, SOC 2, and GDPR.
Security and Disaster Recovery: End-to-end data protection with backups and DR.

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Posit Services

Zifo provides comprehensive support for Posit Workbench, Posit Connect, and Posit Package Manager, ensuring a seamless, scalable, and secure infrastructure.

Key Capabilities:

Deployment: On-premise or cloud deployment of Posit products.
Scalable Compute: Optimized infrastructure for large-scale analytics.
Security and Compliance: GxP and 21 CFR Part 11 compliant environments.
MLOps and Deployment: Deploy models and applications via Posit Connect.
Interactive Applications: Build and host R/Python applications.
Package Management: Efficient package distribution and governance.
Legacy Modernization: Migrate SAS/Excel workflows to R.
Training and Support: Guidance for teams of all skill levels.

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Scientific Workflow Automation

Utilizing cutting-edge cloud technologies like Kubernetes, serverless computing, and AI-driven orchestration, Zifo offers comprehensive support in:

Compute and Orchestration: Flexible, high-performing pipelines through serverless computing, containerization, and managed workflow orchestration.
Data Integration and Management: Effective processing and management of large datasets via data lakes, ETL/ELT tools, and real-time data streaming, ensuring quality and accessibility.
Scientific Tools and Analytics: Seamless API management and integration of scientific tools with AI/ML platforms and data visualization for actionable insights.
Security and User Experience: Robust security with IAM, data encryption, and compliance, alongside intuitive front-end frameworks for enhanced accessibility and reproducibility.

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Modeling and Simulation Tools

Zifo specializes in advanced computational solutions across critical areas, including pharmacometrics (NONMEM, Monolix), molecular modeling and dynamics (GROMACS, AMBER, CHARMM), protein structure and folding (Rosetta, FoldX), and virtual screening (AutoDock, Schrödinger Suite).

Our expertise extends to fluid dynamics (ANSYS Fluent, OpenFOAM), cheminformatics (KNIME, ChemAxon), molecular visualization (PyMOL, Chimera), and omics tools and platforms (Galaxy, Bioconductor), providing a comprehensive approach to scientific challenges.

Zifo actively collaborates with open-source communities and vendors to provide valuable feedback, drive enhancements, and ensure seamless tool adoption.

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Comprehensive Clinical Trial Solutions

Zifo programs complex randomization and IP logistics, ensuring smooth site data entry across diverse therapeutic areas, including oncology, neurology, immunology, cardiology, and more. Our expertise extends to medical devices, dental implants, and vaccine studies.

We excel in drug supply management, IRT integrations, and detailed data mapping. With extensive regulatory experience (FDA, PMDA, EMA, HC), including BIMO and ARM/ARS packages, we support global submissions. Our statistical services cover the entire trial lifecycle, from CRF review and protocol development to DSMB/DSUR support and adaptive trial design. We automate summaries, perform QC with SeeWise, and manage deviations. De-identification expertise (Safe Harbor, expert determination) protects participant privacy.

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Automation

Thousands of clinical trials occur across the globe every year, each with its own set of needs and specific data management requirements. Zifo provides risk-based data management, seamlessly integrating with various EDCs (Medidata Rave, Marvin, Viedoc4, and more), including rescue studies and post-go-live amendments. Our real-time safety reporting automates adverse event and protocol deviation reporting, ensuring regulatory compliance (ICH E2B).

With 15 years of SAS expertise, we create SDTM/ADaM datasets and TLGs, leveraging 100+ macros and an automapper tool. Zifo also pioneers R programming and JSON datasets for cutting-edge statistical analysis. We ensure data quality across multiple sources, eliminating duplicates and irrelevant information. Our expertise extends to decentralized trials, offering innovative approaches and solutions for this evolving landscape.

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Artificial Intelligence (AI)

We are enhancing medical writing with generative AI to quickly create standard study report sections, including safety assessments. Our medical coding tools (eXt, mXt) automate processes for accuracy and efficiency, specializing in ATC coding for better drug classification. A cutting-edge bot automates SDTM package and annotated CRF (aCRF) creation, streamlining clinical data management and ensuring compliance. Our team creates high-quality submission packages (CRT, SDRG, ADRG) using in-house tools, ensuring compliance, accuracy, and timely delivery for successful regulatory submissions.

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Change Management and User Adoption

Key components of Zifo’s change management service include assessing the impact of change, engaging stakeholders early, identifying change champions, designing user-friendly training programs, and ensuring proactive communication. This also encompasses user adoption and training, focusing on user-centric design, planning phased rollouts, motivating early adopters, providing comprehensive onboarding support, and using data, such as adoption rates, to refine the approach for maximum success.

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Post Implementation Operations and Governance

Key components of Zifo’s Operations and Governance services include performance monitoring, continuously tracking the performance of implemented systems, platforms, or processes against defined KPIs; user support and issue resolution, providing ongoing technical support to R&D end-users, including troubleshooting and system updates; bug fixes and updates, identifying and resolving post-deployment issues and ensuring software remains current; data quality management, maintaining high standards of data quality, integrity, and accuracy; scaling and expansion, smoothly handling system expansions as R&D projects grow; and governance policies and procedures, establishing clear guidelines for post-implementation system management, including decision-making, issue escalation, and continuous operational monitoring and improvement.

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Integrated Laboratory

Scientists often spend a significant amount of time navigating multiple systems (both hardware and software) to document their research data and derive meaningful insights. Life sciences leadership is increasingly focused on establishing integrated labs—connecting laboratory instruments, software systems, and data management platforms—to reduce this burden. Key components of an integrated lab include equipment integration, connecting instruments like spectrometers, chromatographs, and microscopes to centralized systems for data exchange, and informatics integration, linking lab management systems (e.g., LIMS) with these instruments to streamline data collection, analysis, and reporting.

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Data Management and Migration

Zifo’s Data Management experts can help you assess the complexity of diverse data types, analyze data structures within legacy systems, and address challenges related to data volume and access control. We provide end-to-end support in developing and executing effective data migration and management strategies. Key elements of our solutions include retaining structure data models, centralized data repositories, automated migration, data backup and redundancy, and robust metadata management.

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Scientific Workflow Design and Development

Zifo’s informatics consultants can help with the end-to-end design and development of various workflows. This includes creating predefined templates for different types of experiments, organizational protocols, and regulatory guidelines. Zifo can also configure informatics platforms to automate data entry, capturing data from connected lab instruments, sensors, or external databases, or even scanning barcodes or QR codes for sample tracking.

Furthermore, Zifo can set up review workflows that ensure data is reviewed and validated by the appropriate personnel, whether peer or lab manager. They can also implement alerts and notifications, setting up automatic reminders for key steps or incomplete data. Finally, Zifo can establish workflows that allow for visualization modules to generate insightful graphs and charts for reporting and data analysis.

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Scientific Platform Installation and Upgrades

Zifo’s Informatics experts can help you install or upgrade these platforms to improve productivity, accuracy, and capabilities of research teams, making the tools aligned with the latest technological advancements.

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Business Process Mapping

Key outcomes of Zifo’s BPM exercise include process optimization, identifying inefficiencies, reducing waste, and improving time management. Zifo also identifies repetitive manual tasks suitable for automation to enhance efficiency and streamline operations. Furthermore, the BPM exercise helps onboard new employees by providing clear visual representations of key processes.

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Software and Application Development

We empower scientists to focus on what they do best — analysis and decision-making — by eliminating the need to navigate complex coding or engineering challenges. Our expertise lies in supporting scientific teams handling multimodal data (such as omics, assays, clinical, population studies, consortium, imaging, etc.). Whether it is creating tailored dashboards, deploying agile RShiny applications, or building organization-wide scientific platforms, we deliver intuitive solutions that enable impactful discoveries.

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Data Solutions

Gaining insights from scientific data demands both domain expertise and technical proficiency. Our team bridges the gap by combining deep scientific knowledge with advanced engineering skills to deliver bespoke solutions. Whether it’s mining public datasets for actionable knowledge, building knowledge graphs for specific use cases, or structuring metadata for data lake initiatives or semantic integration, we provide the expertise to support your research and innovation goals, ensuring we follow the FAIR principles (Findable, Accessible, Interoperable, Reusable) and are conscious of data maturity and readiness.

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Scientific Workflows and Omics Pipeline Engineering

Leveraging our bioinformatics engineering and research infrastructure expertise, clients engage with us to build custom omics workflows, transitioning pipelines from legacy systems to Nextflow for enhanced efficiency, and reducing costs by selecting optimal resources. Additionally, we can develop new pipelines and applications within your existing commercial or enterprise systems, ensuring seamless integration and improved performance.

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Analysis and Insight Generation

When companies partner with us, our mission is to transform their diverse data — whether internal or sourced externally (CRO or public datasets) — into actionable insights. Collaborating closely with scientists, we address key research questions and contribute to strategic goals such as target evaluation, indication prioritization and expansion, understanding drug mechanisms of action, pathway analysis, and biomarker identification to enhance patient selection and enrichment.

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