Compilation of the documentation necessary for the implementation of qualification activities in the project execution phase, during reconstruction, during the initial validation of a device or clean room, and during regular revalidation of a device or clean room.
We offer preparation of the following documentation:
• URS – User requirement specification,
• GMP RA – Risk assessment,
• RDS – Room data sheet/Roombook,
• FS – Functional specification,
• TS – Technical specification,
• DQ – Design qualification,
• MC – Mechanical Completion procedure,
• COMMISSIONING – FAT/SAT,
• IQ – Installation qualification,
• OQ – Operation qualification,
• PQ – Performance qualification,
• TEMPERATURE MAPPING – Cold or Hot Rooms,
Chambers, Warehouse
• Sensor calibration certificates
• Preparation of documentation using advanced programs that ensure good documentation practice (GDP) – COMOS, DMS, and KNEAT