Validation Services & Compliance Support

Validation and compliance is a critical aspect within GxP relevant industries and qualification of computer systems (CSV / CSA), laboratory analytical instruments, equipment, process and Medical Devices with the corresponding compliance approaches, systems and ISO processes play a valuable role in ensuring quality compliance. Whether CLOUD or On-premise, informatics platforms require validation to meet various regulatory requirements and standards. Zifo validation team has experience ranging from Validation strategy definition and project planning to Validation execution (IQ/OQ/PQ) and validation process consultation support (e.g. SOPs / Policies).

Computer System Validation & Consulting Services

CSV validation strategy, IQ, OQ, PQ development and qualification, risk-based validation, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all lab software platforms e.g. CDS, EDC, ELN, LIMS, in the cloud and on-prem

Lab Instrument Validation

Instrument validation strategy, IQ, OQ, PQ qualification, risk-based approaches, execution and reporting across 21 CFR part 11, GLP, GMP, GAMP for all analytical instrument hardware platforms

Quality and Compliance Consulting

New quality system design/delivery/maintenance, auditing against regional regulatory guidelines (21CFRpart11, GLP, GMP, GCP, GAMP5), quality system audit and recommendations, quality system best practice adoption

zifo - software as a medical device companies

Software as Medical Device (SaMD)

SaMD validation strategy, IQ, OQ, PQ development and qualification, software validation execution and regulatory reporting across SaMD regulations