Strategic Maintenance Solutions (SMS) streamlined the Enterprise Asset Management (EAM) validation effort by performing a risk analysis in accordance with GAMP 5 to reduce validation testing.
Situation: A global pharmaceutical manufacturer* was looking to amp up their current EAM program. After numerous years of utilizing their EAM, they decided to re-implement their system to optimize configuration and thereby gain efficiency in maintenance and calibration operations as well as, incorporate multiple sites into one instance. Components of the EAM included the following:
- Multiple organizations and multiple sites within each organization
- Calibration functionality
- EAM workflow
- EAM mobile solution for work order management
- EAM mobile solution for inventory management
- EAM Custom reports
Solution: Like other pharmaceutical related organizations, this client needed to validate their EAM in accordance with FDA regulations, specifically 21 CFR Part 11. SMS developed a validation strategy designed to streamline the validation effort resulting in a decreased validation time. By implementing this validation strategy, the validation time was reduced. Program elements included a risk analysis considering:
- GAMP 5
- GxP applicability
- Past experience with the EAM within the organization
Results: The validation strategy was designed to include eight plants across the United States. SMS achieved the following results:
- Over 85% reduction in testing out-of-the-box functionality of the core application.
- Over 55% reduction in testing out-of-the-box functionality of the calibration module.
- Over 70% reduction in testing out-of-the-box functionality of the mobile applications.
*SMS is committed to the security and privacy of our clients.
