Millipore Technical Publications |
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The Guava PCA and PCA-96 Systems: Support for compliance for 21 CFR Part 11 | ||
| Lit No: | MK01008880 | |
| Year: | 2006 | |
| 21 CFR Part 11, Electronic Records and Electronic Signatures, is the FDA regulation directing the management of electronic records and electronic signatures in open and closed systems. The regulation specifies the criteria under which the agency considers electronic records and electronic signatures to be the equivalent of paper records and handwritten signatures. The regulation became effective in March 1997. |
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