Validation · Pharmaceutical Industry Practical Discussion
What documentation is required during pharmaceutical technology projects?
The core document set from requirements to release, scaled by risk.
- Concept
- Practical example
- Process
- Documentation
- Technology
- Quality considerations
- Example use case
01Concept
Documentation proves that a system was specified, built and tested to meet its intended use. GAMP 5 encourages scaling it to risk and system complexity rather than producing every document for every system.
02Practical example
A configurable laboratory system needs a URS, configuration specification, risk assessment, test evidence and a validation report; custom code adds design specifications and code review.
03Process
- 1
Validation plan
- 2
User requirements
- 3
Risk assessment
- 4
Specifications
- 5
Testing (FAT/SAT/IQ/OQ/PQ)
- 6
Traceability
- 7
Validation report
- 8
Periodic review
04Documentation
- Validation plan
- URS
- FS / DS
- Risk assessment
- Test protocols and scripts
- Traceability matrix
- Validation report
05Technology
Electronic validation tools and document management systems speed review and approval.
06Quality considerations
Good documentation practice and ALCOA+ apply to validation evidence as much as to batch records.
07Example use case
A traceability matrix shows an inspector every requirement linked to its test result.
Example use cases are illustrative. This article is general educational information, not regulatory or legal advice.
