Often, industry groups will publish recommendations with best practices for specific activities.
Here are a few examples (again with applicability to this program):
International Society for Pharmaceutical Engineering (ISPE) publishes the Good Automation Manufacturing Practices (GAMP), the current (as of 2017) being GAMP®5
Pragmatic and Practical Industry Guidance
GAMP®5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner.
This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification.
Risk-Based Approach
GAMP® 5 has become the computer system validation ‘bible’ for the pharmaceutical industry. The concepts described in the approach are quite sound and applicable to computer systems validation across the life cycle disciplines.
As the title suggests “A Risk-Based Approach to Compliant GxP Computerized Systems”, the approach is, definitely, risk-based which aligns with the “current thinking” by the regulatory bodies.
We’ll talk (much) more about GAMP®5 later in this program.
The bottom line is that the life sciences are strictly regulated and there’s a lot of “help” available.
This program will pull the best information from the various sources to help you understand what is required for a compliant computer validation system and the best practices that are required in implementing your system.
Governance
Since you’re in a regulated company, you probably already recognize the importance of governance for many aspects in your work life.
Validation needs governance, too. Successful governance, per GAMP® 5 related to validation includes:
- Establishing computerized systems compliance policies and procedures
- Identifying clear roles and responsibilities
- Training (we should point out that this should really be competence since training is only one way this can be done)
- Managing supplier relationships
- Maintaining a system inventory
- Planning for compliance and validation
- And Continuous improvement activities
