Electronic records and signatures

In 1990, the FDA published the electronic records and signatures rule as an initiative for the pharmaceutical industry. This allowed the use of electronic signatures in lieu of handwritten ones. This initiative opened the door to fully electronic documents. The rule became effective in August 1997 and addresses both electronic records and electronic signatures. 

International Society for Pharmaceutical Engineering (ISPE) (2002), Good Practice and Compliance for Electronic Records and Signatures, Part 1, Good Electronic Records Management, ISPE and PDA. 

Validation of functions that are required to meet electronic records and signature compliance, such as 21 CFR Part 11. 

Validation Compliance with Electronic Records and Signatures... 

In March 1997, the US Food and Drug Administration (US FDA) issued a regulation on electronic record and signatures 21 CFR Part ll.30 The scope of 21 CFR Part 11 is to... 

PDA/GAMP Good Practice and Compliance for Electronic Records and Signature, Part 2, Complying with 21 CFRPart 11, Electronic Records and Electronic Signatures, Version 1, September 2001. Published jointly by PDA and ISPE. 

All GxP functions, processes, components, and devices identified within the GxP assessment should be challenged as part of the Design Review. Consideration may also be given to occupational health matters such as the potential effects of the computer system and associated equipment on the personnel who may use or contact the system. GxP functionality includes the use of electronic records and signatures. Hybrid systems must be dehned and subject to a verification process to determine whether or not they are robust. It is often nsefnl for processes to be mapped, showing critical points in the process and how varions compnter systems support these critical process points. 

With regards to your responses concerning the use of electronic records and signatures, we find your reply inadequate. 21 CFR 11.100 requires that prior to the time of use. 

Your firm failed to validate the electronic documentation system [and associated electronic records and signatures prior to implementation. [FDA Warning letter, 2000]... 

Method of storing and retrieving data Andit trail and copying of records Electronic records and signatures specification Safety and environmental specifications of the IPC Fanlt diagnosis Reporting Interfacing... 

U.S. Code of Federal Regulations Title 21, Part 11 (Revised as of April 1, 2002), Electronic Records and Signatures. http //www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm7CFR-Part=ll showFR = 1. 

The degree of compliance in regard to the use of electronic records and signatures using technical and procedural controls (ref. 21 CFR Part 11, etc.). 

Twelve basic requirements for electronic records and signatures are defined in U.S. regulation 21 CFR Part 11 concerning electronic records and electronic signatures. Table 32.4 suggests necessary actions to comply with spreadsheet applications. 

Compliance with Client Policies (e.g., GxP, qualification, electronic records and signatures)... 

FDA regulation 21 CFR Part 11 on electronic records and signatures requires records to be trustworthy, a word that combines all requirements as mentioned above. 

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