21 CFR Part 11 Compliance with the Vi-CELL BLU Cell Viability Analyzer

The following document describes the relevant portions of the 21 CFR Part 11 regulations and their implementation using the Vi-CELL BLU control software. The implementation and compliance of 21 CFR Part 11 remains the responsibility of the organization or entity creating and signing the electronic records in question. Proper procedures and practices, such as GLP and GMP, are as much part of the overall compliance with these regulations as are the features of the Vi-CELL BLU control software.

21 CFR PART 11

The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the FDA to define the requirements for records in electronic form and the criteria for approved electronic signatures.

ELECTRONIC RECORDS

Per Section 11.3 subpart A of 21 CFR Part 11, an electronic record is ‘any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system’. This refers to any digital computer file submitted to the FDA, or any information not submitted but that needs to be archived. Public docket No. 92S-0251 of the Federal Register (Vol. 62, No. 54) identifies the types of documents acceptable for submission in electronic form and where such submissions may be made.

FDA REQUIREMENTS

The general comments section of the ruling states that ‘The agency emphasizes that these regulations do not require, but rather permit, the use of electronic records and signatures’. The introduction to the final ruling states that ‘The use of electronic records as well as their submissions to FDA is voluntary’.

If electronic submissions are made, Section 11.2 explains that ‘persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures provided that: (1) The requirements of this part are met; and (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251’.

The Vi-CELL BLU control software has been designed to enable users to comply with the electronic records and signatures rule.

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