Quality Electronic Records and Signatures: Supporting Compliance with 21 CFR Part 11
The FDA published CFR Part 11, sometimes referred to as Title 21 CFR Part 11, in 1997, specifies the standards
The FDA published CFR Part 11, sometimes referred to as Title 21 CFR Part 11, in 1997, specifies the standards
The Medical Device Amendments of 1976 regulates consumer access to new and improved devices, while keeping unsafe or ineffective ones