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- Tag: fda
Tag: "fda"
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...unction correctly to prevent harm. Product Quality: Errors in software could compromise the final product. Regulatory Compliance: Standards like FDA 21 CFR Part 11 and EU Annex 11 require a...
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A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, t...
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...arly on as opposed to having it as an afterthought or manual exercise. Medical device developers in the US have to comply with the FDA Cybersecurity Guidance documents that refer to the widely r...
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...all under regulations and which don't. From FDA 21 CFR 11.3(b)(6) “Electronic Record means any combination of text, graphics, data, audio, pictorial, or other information representation i...
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This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...
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Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA....
- App Central
- Article
- compliance
- e-signatures
- fda
- softcomply
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In FDA (U.S. Food and Drug Administration) and ISO 27002 compliant processes, digital signatures play a crucial role in ensuring the integrity, authenticity, and security of electronic records and s...
- App Central
- Article
- bitbucket
- compliance
- fda
- iso
- signatures
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