Electronic signatures regulations

Automated dissolution equipment in most cases must be compliant with the FDA electronic records and electronic signatures regulation (21 CFR Part 11). The requirements of the regulation include use of validated systems, secure storage of records, computer generated audit trails, system and data security via limited access privileges, and the use of electronic signatures. 

CDER Electronic Records Electronic Signature Regulations. This page provides links to pertinent Code of Federal Regulations and Federal Register documents. 

Compliance with Electronic Records and Electronic Signatures regulations... 

Another important aspect for discussion is the impact of regulations, spe-cihcally the regulation on electronic document management and electronic signatures, 21 CFR Part 11, published by the Food and Drug Administration (FDA) for the hrst time in 1997 [1] (also see Chapter 26, which covers 21 CFR Part 11 in detail). Since that time the draft rules of Part 11 have been withdrawn and reissued along with various guidance documents [2-3], Some of the key points of Part 11 are as follows ... 

FDA. Code of Federal Regulations, Title 21 Food and Drugs, Part 11 Electronic Records Electronic Signatures Final Rule, Fed Regr 62 (54), 13429-13466 (20 March 1997). 

The first draft of the new requirement had draconian security requirements, softened (as is common) after a comment period Demands for biometric identifiers were replaced with password control options. But the revised final regulation was still broad in scope and necessitated extensive documentation and testing for all systems used in the industry (with even stronger controls if the user opted for electronic signatures). 

CFR - Part 77 is a federal law that regulates the submission of electronic records and electronic signatures to the FDA. Of particular interest to the statistical programmer are the following requirements of Part 11 ... 

CFR11 is a U.S. regulation requiring security of electronic records and electronic signature requirements. It applies to... 

Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records Electronic Signatures, FDA, 2003 (http //www.fda.gov). Validation/compliance documents found under the Parenteral Drug Association (PDA) (http //www.pda.org). 

Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 11, electronic records and electronic signatures. Federal Register 1997 62 13, 430-66. 

Code of Federal Regulations Guidance for Industry, Part 11, Electronic Records Electronic Signatures, Scope and Application, US Department of... 

Existing system applications will need to be evaluated and applicable GMP issues and risks identified. Whether it be legacy systems, systems to be revalidated, or systems yet to be validated, the critical parameters, data, and functions that direcdy impact GMP should be clearly identified and formally documented. Each system should be assessed under a formal procedure to determine compliance with the regulations for electronic records and electronic signatures. Any resulting action plan should include system prioritization and implementation timings. 

Newly sanctioned systems will require compliance with regulations for GMP electronic records and electronic signatures, and definition of the functionality required will need to be included. 

In considering electronic records and electronic signatures (ERES) the pharmaceutical manufacturer must address the system quality-related critical data collection and processing functions that come under ERES regulations (see Secs. IV and V). 

One of the most important procedures to be developed and followed is the administration and retention of electronic records. Part 11 requires the retention of electronic records in electronic form. For regulated systems in which electronic signatures are not implemented (hybrid systems) the electronic record requirements (Sub-Part B) in Part 11 are applicable, and the electronic records are maintained and retained in electronic form for the period established by the predicate rule. 

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