John Mill Training And Development Compliance 21 CFR Part 11 Electronic Records regulations Ensure Compliance:

21 CFR Part 11 Electronic Records regulations Ensure Compliance:


At a minimum, a vision system should Electronic Records, in addition to performing all its required functions, be able to do the following to be compliant with 21 CFR Part 11 Compliance.

Restrict access to the system to authorised persons

Upon request, efficiently locate appropriate records and provide suitable copies for review

Use audit logs that record the date and time of each operator action and each entry that creates, changes or deletes an electronic record.

Confirm the identity of any person who electronically signs a registration

Make sure that no changes obscure previously recorded data

Prove that the results it generates are legitimate by validating them against test data with known results

21 CFR Part 11 Electronic Records Compliance Whitepaper

A compliant vision system must have an Electronic Records secure authentication mechanism to prevent unauthorised access. The best solution is to link to the manufacturer’s active directory account to verify users and issue appropriate certificates. Compliance Any user or login changes must be recorded and appear in the audit log.

Use Audit Logs

In a compliant vision system Electronic Records, changes to a setting, for example, of a parameter on an image-based scanner, will create a timestamped record, a record that cannot be edited or deleted, and can be reviewed by an auditor at a later time.


Users of a compliant vision system Electronic Records must demonstrate proper software installation via Installation Qualification (IQ), proper software operation via Operational Qualification (OQ), and proper system operation in context of production through Performance Qualification (PQ).

Cognex supports compliance with 21 CFR Part 11 Electronic Records

While end users are responsible for final validation to ensure Electronic Records full compliance, Cognex, together with its global network of integration partners, provides all the documentation needed to support the IQ and OQ, as well as the software functions needed to complete

21 CFR Part 11 – Data Integrity

The Code of Federal Regulations Title 21, Part 11 applies across a range of regulated industries including pharmaceuticals, biologics, medical devices and food products (human and veterinary).

Companies in these segments doing business in the U.S., providers of raw materials and components to pharmaceutical companies and contract labs commissioned to perform analysis work must all operate to ensure electronic records and electronic signatures are trustworthy and reliable.

Global equivalents of 21 CFR Part 11 Compliance

Part 11 and Annex 11 provide detailed information on the generation and storage of electronic data generated during the course of the Good Practice (GXP) or manufacturing work. Annex 11 offers guidance for operating in a Good Practice

Compliant (GXP) space, while Part 11 is a list of prohibitions, but these texts are largely harmonised. The most significant differences include how individuals are to be identified and expectations regarding personal responsibility for the use or abuse of secure access.

ERES Guidelines: Application for Approval of Drug Licences (Japan)

The Japanese guidelines for generating and storing electronic records correspond exactly to the intent of Part 11 of the United States. Companies that strictly adhere to 21 CFR 11 will comply with ERES guidelines, while Japanese companies will need to take certain precautions to fully adhere to Part 11 for products sold in the United States.

Food & Drugs Act, Division C.02 (Canada)

Canadian regulations are drafted to attribute responsibility for compliance to the individual to whom United States Part 11 Compliance regulations provide a set of requirements without specifically identifying the responsible parties.

The Canadian guidelines also take into account Mutual Recognition Agreements (MRAs) with countries whose standards are equivalent in scope and depth. Mutual recognition agreements allow for faster imports and approvals of raw materials and finished products across borders.

Documents on related codes, regulations and guidelines

21 CFR provides in-depth guidance for the application of Good Manufacturing Practices (GMP, 21 CFR Compliance 210 and 211), Good Laboratory Practices (GLP, 21 CFR 58), and manufacturing of biopharmaceuticals (biopharmaceuticals), including:

21 CFR 210-211:

Guidelines for the production, processing, packaging or storage, according to current Good Manufacturing Practices (cGMP), of drugs and finished pharmaceutical products

For clean room operators, 21 CFR Parts Compliance 210-211 emphasises the importance of validated quality controls for all stages of the manufacturing workflow, including air quality monitoring. All work related to drug manufacturing and packaging must be conducted and recorded in accordance with written Standard Operating Procedures (SOPs).

All records relating to the manufacture of a drug will be reviewed annually. As noted in Part 11, personnel engaged in drug manufacturing and packaging must have adequate and ongoing training and education to perform their assigned duties in a cGMP environment.

Guidelines for the production and distribution of biopharmaceuticals

For clean room operators, 21 CFR Part 600 provides preliminary guidance on 21 CFR Part 11 record keeping requirements. All biologic manufacturing records must simultaneously capture all steps as they occur, including air quality monitoring. The record should include who conducted the air quality audit, the date and time of the audit, and any deviations (and associated reasons) from the SOP.

 Best Practices for Information Systems in Regulated Environments GxP (2007)

United States Food and Drug Administration (FDA):General principles of software validation; Final Guide for Industry and FDA Personnel (2002)

These guidelines are complementary to 21 CFR 11 and indicate that all steps of data management, from data generation to review and archiving, must be performed according to defined quality controls.


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