What to Know About Data Management and 21 CFR Part 11 and EudraLex Annex 11 Compliance

by Braj Nandan Thakur | December 6, 2023

Scientist sitting a desk, in a lab, smiling, using a bioprocessing software to help with 21 CFR part 11 compliance

Accurate and timely record-keeping is essential to ensure quality during the drug manufacturing process. For this purpose, paper-based records can be more problematic than effective. Not surprisingly, paper-based records are being replaced by software that provides a process to collect and manage records and signatures in electronic formats.

Electronic records and signatures are considered equivalent to paper-based versions if several key criteria are met. Electronic records and signatures must:

  • Be created, maintained, and archived to ensure authenticity and integrity
  • Link to individual users with the ability to create, modify and approve them
  • Be unique to each user
  • Created and managed by a system that is validated to ensure accuracy, reliability, and consistent performance

Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) established United States Food and Drug Administration (FDA) regulations to help ensure that electronic records and signatures are reliable and can be considered equivalent to paper records and handwritten signatures for FDA purposes. Similar regulations are provided by the European Union’s EudraLex Volume 4 Annex 11 (Annex 11).

With the right software, paper-based record keeping and handwritten signatures can migrate to an electronic format and deliver a set of benefits including:

  • Defining user roles and permissions
  • Creating an immutable audit trail
  • Increasing record reliability and accuracy
  • Facilitating the search process to support audits and investigations
  • Ensuring data backups and redundancies
  • Enabling more robust collaboration

Among the regulations covered by 21 CFR Part 11 and Annex 11 are those for controls for closed systems, signature attributes such as time and date of signature, unique signatures,  validation documentation, and data accuracy.

Learn more about these regulatory expectations as well as key considerations that will help ensure a smooth transition to electronic records.

Explore how our data analytics solutions can help support compliance with regulations outlined in 21 CFR Part 11 and Annex 11.

Global Product Manager

Braj Nandan Thakur is the Global Product Manager for data analytics and automation software. He works to build roadmaps and strategy for the software that meet and anticipate industry needs and assist companies in their digital transformations. Braj has implemented enterprise-level digital solutions from R&D through to manufacturing. He holds a master’s degree in bioinformatics from the University of Allahabad and a PGDM from the Institute of Management Technology, Hyderabad, India. 

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