I'm fairly new to ISO 13485 and FDA 820 requirements with a new company I've joined though I've been dealing with ISO 9001 since the dark ages so quite knowledgeable on most of these requirements.
I've recently started revamping the CAPA process in this company and one thing I find extremely onerous is that physical signatures and dates (or Part11 compliant digital signatures) are required after the following steps:
• after the investigation is complete
• after root cause analysis is complete
• and after the corrective action plan is complete
Therefore physical signatures (not just a general 'approval'...I realize FDA is big on actual signatures) are required at 3 different points in the process, which si simply extensive administrative burden. I'm trying to get rid of the signatures and have more efficient ways of capturing approvals, but I'm told from a regulatory perspective we must retain the signatures.
Neither ISO 13485 8.5.2/8.5.3 nor FDA 820.100 say anything about CAs/PAs needing to be approved.
I therefore welcome some experienced insight in regards to what you are accustomed to seeing from FDA inspectors and/or ISO 13485 auditors when it comes to 'approvals' on CAs and PAs. Some level of approval is required and I've typically had this after RCA and CA plan has been completed, then at the conclusion of the effectiveness check of the CA, but I've moved away from signatures over the years and simply captured the approvals in a log which is good enough from and ISO 9001 perspective.
I look forward to your feedback. Thanks.
Dave
I've recently started revamping the CAPA process in this company and one thing I find extremely onerous is that physical signatures and dates (or Part11 compliant digital signatures) are required after the following steps:
• after the investigation is complete
• after root cause analysis is complete
• and after the corrective action plan is complete
Therefore physical signatures (not just a general 'approval'...I realize FDA is big on actual signatures) are required at 3 different points in the process, which si simply extensive administrative burden. I'm trying to get rid of the signatures and have more efficient ways of capturing approvals, but I'm told from a regulatory perspective we must retain the signatures.
Neither ISO 13485 8.5.2/8.5.3 nor FDA 820.100 say anything about CAs/PAs needing to be approved.
I therefore welcome some experienced insight in regards to what you are accustomed to seeing from FDA inspectors and/or ISO 13485 auditors when it comes to 'approvals' on CAs and PAs. Some level of approval is required and I've typically had this after RCA and CA plan has been completed, then at the conclusion of the effectiveness check of the CA, but I've moved away from signatures over the years and simply captured the approvals in a log which is good enough from and ISO 9001 perspective.
I look forward to your feedback. Thanks.
Dave