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GxP Asset Management

Managing inventory, commissioning, maintenance and entire lifecycle of physical assets (e.g. equipment, instruments, manufacturing machinery etc.) is a key requirement for manufacturing industries. The business application used for this is Enterprise Asset Management (EAM). For Life Sciences this is a key system because of its regulatory and GxP compliance.
Setup, configuration, integration, validation, and training are all required to effectively choose, use, and maintain EAMs. Some or all the following steps will be important:
Identify requirements: First, identify your organizations specific needs and requirements. Determine information such as what types of assets, how many sites, departments, regulatory compliance requirements etc.
Research available options: Research the different systems on the market and compare them against your organization’s requirements. Consider factors such as functionality, ease of use, compatibility with existing software and instrument hardware, validation efforts needed, and cost.
Select the right platform: Once you have narrowed down your options, select the system that best fits your organization’s needs. Make sure to involve stakeholders in the decision-making process, including lab operations, metrology, QC/QA groups, and IT personnel.
Plan the deployment: Develop a deployment plan that outlines how the system will be hosted, configured and if any data will be migrated from existing systems. Assess the need for validation and plan accordingly.
Test the platform: Before deploying the system, conduct thorough testing to ensure that it meets your organization’s requirements and functions properly.
Deploy the platform: Once testing is complete, deploy the system according to your deployment plan.
Train users: Provide training to all users to ensure they are familiar with the new system and know how to use it effectively.
Monitor and maintain the system: Regularly monitor the system to ensure it functions properly and data is captured and managed effectively. Make sure to perform regular backups and updates and address any issues that arise in a timely manner.
By following these steps, you can successfully choose, deploy, and maintain an EAM, handle regulatory compliance, help improve data management and collaboration.
Zifo provides vendor selection, configuration, integration, rollout, validation, and managed services for EAM systems. These services are supported by strategic partnership and experience with the industry leading EAM providers.

Blue Mountain

Leading the Life Sciences in asset management for 35 years, Blue Mountain® has a unique position in the life sciences industry backed by a proven leg...

Blue Mountain

Leading the Life Sciences in asset management for 35 years, Blue Mountain® has a unique position in the life sciences industry backed by a proven legacy. Founded in 1989, Blue Mountain offers a complete, integrated solution, helping hundreds of Pharmaceutical, Biotech, Cell and Gene Therapy, Medical Device, and Contract Manufacturing companies. From set-up to installation and from training to validation, our company helps life sciences manufacturing master GMP asset management by implementing our best-in-class software – enabling them to leverage the cloud, drive paperless processes, and ensure regulatory compliance. Blue Mountain is backed by Accel-KKR and headquartered in State College, PA.