Documentation

We are able to generate comprehensive validation documents, e.g.:

User Requirements Specifications (URS), Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) protocols and reports, GMP reviews.

Pre- qualification reports for Facilities, Equipment and Utilities.

Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for Facilities, Equipment and Utilities.

Documents can be in PEV format or customised to suit specific client requirements.