Our team has a deep understanding of serialization, earned from years of working in Quality Operations, Pharmaceutical Productions and packaging, cGMP/GAMP, as well as many years in providing technology solutions for the most demanding regulatory environments.
So we know that reliable serialization needs a thorough understanding of the qualification and validation processes. We are uniquely capable of providing serialization assistance and supporting it with qualification documentation.
With documentation that conforms to current pharmaceutical standards and GAMP 5 regulations we open the door to serialization locally, as well as globally.
Our team of experts is there to guide and consult in any way to ensure our clients’ success in their serialization efforts.
Documentation deliverables:
- Project Plan (PP) with subsidiary management documents and records
- Configuration Specification (CS)
- Functional Specification (FS)
- User Manual (UM)
- Administration Manual (AM)
- Integration Manual (IM)
- Risk Assessment (RA)
- Validation Plan (VP)
- Installation Qualification (IQ) protocol, test cases and report
- Operational Qualification (OQ) protocol, test cases and report
- Performance Qualification (PQ) protocol, test cases and report
- Traceability Matrix (TRM)
- Validation Summary Report (VSR)