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21 CFR Part 11 Compliance for Regulated Industry

21 CFR Part 11 Compliance for Regulated Industry

Any data which is created and stored in an electronic form in a regulated industry must comply with 21 CFR Part 11 Compliance. To elaborate, any software solution which integrates with existing silos of the regulated companies for data management must be validated for electronic records and electronic signatures (ERES).

The guidelines of 21 CFR Part 11 for ERES can be summarized as follows:

  • Safeguard the integrity, confidentiality of electronic records.
  • Validation of systems to ensure accuracy, reliability, consistent performance, and the ability to differentiate invalid records.
  • Create accurate and complete copies of records, in both human readable and electronic form, for the FDA to inspect and review.
  • Guarantee a secure environment for easy retrieval of electronic records.
  • Provide a user based authentication system to combat data manipulation & unauthorized user access.
  • Track all iterations made to electronic records throughout their lifecycle.
  • Ensure revision and change control procedures for the audit trail.
  • Ensure that all the electronic signatures will have printed name of the signer, the date & time, the meaning associated with the signature.

21 CFR Part 11 Compliance Challenges

While the FDA’s 21 CFR Part 11 compliance helps mitigate the data integrity challenges, there are some hidden compliance gaps in the business processes.

Some of the common problems include:

  • The inability of software applications used for electronic submissions to enable 21 CFR Part 11
  • Lack of SOPs that describe how to use software functionality in compliance with 21 CFR 11
  • Inconsistent communication and lack of training
  • Nonalignment of different functional perspectives
  • Lack of methods to track issues and progress
  • Lack of coordination between multiple sites & divisions

Xybion’s Take

Xybion offers end-to-end software solutions which can help enterprise content management systems, asset management systems, equipment solutions to enable 21 CFR Part 11 for intended users.

Xybion’s integrated platform for enterprise quality management delivers powerful web-based capabilities to facilitate compliance with regulatory guidelines such as ISO 9001, ISO14001 GxP, FDA 21 CFR Part 11.

In addition, Xybion’s enterprise-ready solutions help big pharma & life sciences streamline their clinical laboratory workflows in adherence to 21 CFR Part 11. The solutions create a secure environment to track electronic signatures, records archival, and reporting.

If this is not enough, Xybion’s fully integrated, preclinical software platform provides a built-in flexibility, which enables integration with GLP and non-GLP compliant laboratory environments.

Learn more about our data integrity solutions!

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