Nice example of how to explain the predicate rules to someone.
Relationship to the Predicate Rules
When considering the instances in which Part 11 must be applied, you should first refer to the Predicate Rule
Glossary Rule
to determine the records that are considered “required.”
For example, section 58.130(e) of Good Laboratory Practices requires all data generated during the conduct of a nonclinical study be recorded and signed. If this is done electronically, then Part 11 applies.
Part 11 specifies, in detail, what must be done to those records to ensure that they are acceptable to the FDA.
In the context of Part 11 the predicate rules are GMP,GLP and GCP regulations that require and define the documentation that the firm has choosen to keep electronically.
[quote=gokeeffe]Nice example of how to explain the predicate rules to someone.
Relationship to the Predicate Rules
When considering the instances in which Part 11 must be applied, you should first refer to the Predicate Rule
Glossary Rule
to determine the records that are considered “required.”
For example, section 58.130(e) of Good Laboratory Practices requires all data generated during the conduct of a nonclinical study be recorded and signed. If this is done electronically, then Part 11 applies.
Part 11 specifies, in detail, what must be done to those records to ensure that they are acceptable to the FDA.[/quote]
What are the specific predicate rules for a medical device manufacturing plant. 210 and 211 are for pharma, 58 is for support of clinical studies so that is outside of the scope of the manufacturing site (would be covered by the R & D section I think)
Does that mean that we are talking about only 820 as an applicable predicate rule or am i missing some?
Would appreciate all opinions