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Hi everyone,
This is my first time posting here. I am in doc control at a biologics company in Pennsylvania and am having some documentation questions. We are held to 21 CFR 210 and 211, 21 CFR 600, 601 and 610 and 21 CFR 1271. Currently I'm in a pickle over work instructions or job aids and their documentation in the quality system.
We currently have them tacked up in our offices and cleanroom as unregulated posters/signage. In an outside audit, the auditor spoke of the need for QA to control this documentation. I was wondering if anyone who has been in a similar situation could point me in the right direction regarding their move into the quality system. Specifically I was wondering:
1) Do these documents have to be incorporated into the Quality system with their own document class (e.g. WI-01-001) subject to the normal change control process?
OR
2) Will setting them up with simply a signature for Quality Assurance to approve them (and treat them more as forms or records) be enough to fulfill FDA requirements?
OR
3) Is there some sort of in between that would satisfy FDA regs? Any advice on the subject would be greatly appreciated. Thank you.
This is my first time posting here. I am in doc control at a biologics company in Pennsylvania and am having some documentation questions. We are held to 21 CFR 210 and 211, 21 CFR 600, 601 and 610 and 21 CFR 1271. Currently I'm in a pickle over work instructions or job aids and their documentation in the quality system.
We currently have them tacked up in our offices and cleanroom as unregulated posters/signage. In an outside audit, the auditor spoke of the need for QA to control this documentation. I was wondering if anyone who has been in a similar situation could point me in the right direction regarding their move into the quality system. Specifically I was wondering:
1) Do these documents have to be incorporated into the Quality system with their own document class (e.g. WI-01-001) subject to the normal change control process?
OR
2) Will setting them up with simply a signature for Quality Assurance to approve them (and treat them more as forms or records) be enough to fulfill FDA requirements?
OR
3) Is there some sort of in between that would satisfy FDA regs? Any advice on the subject would be greatly appreciated. Thank you.
