A Fortune 100 Life Science Corporation approached PCI with a need to standardize, harmonize, and consolidate its calibration processes at multiple sites into a standard, compliance process. A key objective of this project was to implement a compliant Global Calibration program using a paperless calibration solution. PCI provided a comprehensive strategy and approach for the implementation of a paperless calibration program that offers a consistent method of tracking, documenting, and managing the client’s global calibration program.
The scope of this project provided challenges with implementing a holistic solution for 8 sites in 3 countries that were currently operating on different computer software and hybrid solutions – with some sites depending completely on manual paper based tracking to perform and manage calibrations. The different software at the sites ensured inconsistency which raised compliance concerns.
The implementation began by conducting assessments of each site’s current operations, developing the functional requirements of a single software solution for all sites, and developing an implementation strategy that provided consistent, compliant global instrumentation management.
Implementation of the overall project included:
- Developing global policies and SOPs
- Managing and reporting metrics that tracked project milestones
- Data Cleansing and Subject Matter Expert review to ensure data migration readiness
- Data Verification Testing certifying data compliance at each data transition stage
- Developing custom deployment strategies for each site
- Developing site Steering Committees and training QA and end users on the solution
During the deployment and implementation, PCI managed delivery of a compliant global paperless calibration solution while addressing any barriers to success to move the project forward successfully.
Benefits to the client include:
- Harmonization of policies and procedures
- Compliant calibration programs that clearly display evidence of control
- Over 30% reduction in labor required to maintain the calibration programs
For additional information, contact:
Consulting Services Team