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READ ALL SECTIONS FOR INSTRUCTIONS. Answer all applicable questions. Answer N/A if the question does not apply. Complete electronically. No handwritten versions accepted. Submit a signed electronic
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Who needs part 11 electronic records?

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Any organization or individual who deals with electronic records in a regulated industry such as pharmaceuticals, medical devices, biotechnology, etc. may need to comply with part 11 electronic record requirements.

What is Part 11, Electronic Records; Electronic SignaturesScope ... Form?

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Part 11 electronic records are electronic records that comply with the requirements set forth in Title 21 CFR Part 11, which regulates the use of electronic records and electronic signatures in various industries.
Any organization that is subject to FDA regulations and uses electronic records to document activities related to the manufacturing, processing, packing, or holding of a product is required to file part 11 electronic records.
Part 11 electronic records can be filled out using electronic systems that comply with the requirements set forth in Title 21 CFR Part 11. This includes implementing controls for electronic signatures, audit trails, and data security.
The purpose of part 11 electronic records is to ensure the reliability, integrity, and authenticity of electronic records used in regulated industries.
Part 11 electronic records must include information related to the manufacturing, processing, packing, or holding of a product, as well as any electronic signatures used to sign off on these activities.
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