Processes:
- Retention
- Archive and Retrieval
Retention
Policies for retention of regulated recors should be in lace, based on clear understanding of the regulatory requirements and company regulations..
Archive and Retrieval
Procedure must be in place for taking records off line to a different location. Key requirements are: Taking records off line to a different location Key requirements GxP records secured against willful or accidental damage during retention period Initially and periodically checked Content and meaning preserved- GxP records secured against willful or accidental damage during retention period
- Initially and periodically checked (documented)
- Content and meaning is preserved
- Reasonable access by regulators possible