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Government and Regulatory Standards and Guidelines

Food and Drug Administration (FDA)

CFR Title 21 Part 11 Electronic Records; Electronic Signatures
The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

CFR Title 21 Part 820 Quality System Regulation
Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.

General Principles of Software Validation; Final Guidance for Industry and FDA Staff
This guidance outlines general validation principles that the Food and Drug Administration (FDA) considers to be applicable to the validation of medical device software or the validation of software used to design, develop, or manufacture medical devices.

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