Procedures - Standard Operating Procedures
Procedures and routine activities in the test facility have to be documented.
There should be written Standard Operating Procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by the test facility.
The responsibility of test facility management is to:
- Ensure that appropriate and technically valid Standard Operating Procedures are established and followed
- Approve all original and revised Standard Operating Procedures
- Ensure the maintenance of an historic file of all Standard Operating Procedures - to be retained in the archives