21 CFR Part 11 – How to Make Sure You Meet Regulatory Requirement

December 9th 2021

21 CFR Part 11 has allowed many companies to realise the benefits of a paperless data-management system. While many believe that it is just an additional regulatory hill to climb, it’s important to give credit to the many benefits of a paperless laboratory or manufacturing facility. The FDA regulations are there to ensure that companies choosing to use an electronic record-keeping system maintain document security and authenticity. It ensures accountability and traceability, which are of upmost importance for companies in the pharmaceutical or medical-device sector.

But what does it entail?

The FDA guidelines ensure that:

  • Access to electronic records is limited to authorized individuals
  • Account sharing between individuals, groups or departments is not permitted
  • Adequate security protocols are followed to ensure the integrity of passwords and login credentials for all users
  • Electronic signatures cannot be transferred or copied between documents
  • Electronic signatures are certified to be the same as handwritten signatures, and that the certification is mailed to the FDA
  • Records are tracked through document controls and an audit trail that monitors changes and discerns invalid or altered records


So how do you make sure that you are properly compliant? Below is a quick step-by-step guide of how to manage your compliance in the best way.

  1. Determine whether 21 CFR Part 11 applies to your company

First, you need to make sure that the regulation applies to your business. A common phrase we hear from businesses who think that 21 CFR does not apply to them, is that their master records are all paper based. But then, the documents will afterwards be uploaded to a central file system or internal database. They think that a paper-based record, means that they won’t have to deal with 21 CFR Part 11 at all, however as soon as this document is scanned and uploaded to the server, the company should be complying with 21 CFR Part 11.


  1. Follow best practices in data protection and password security.

All staff members with access to the systems need to have the correct levels of permissions and access. Best practises regarding passwords should also be applied. Having a piece of data collection technology such as VIDA, which can allow different levels of access to different members of the team whilst collecting data and transfer data securely to the internal system can help combat this.


  1. Establish clear audit trails for traceability.

You need to have clear audit trails to show records of which user performed which action, using which piece of kit and at what time. There must be trails of when records were created, modified, and deleted. Gathering this level of metadata is something with VIDA’s data collection system can do automatically. So considering adding in a piece of data collection hardware to your laboratory could help to combat this problem.


  1. Follow guidelines on electronic signatures.

Information must be reviewed and approved using a form of electronic signature. This can be done using a biometric, a digital signature, scanning, handwriting capture or an electronic signature. VIDA allows users to scan into the system using an RFID card each time they use it. This allows full monitoring and authorisation of data produced.


  1. Validate for IQ, OQ, and PQ.

These acronyms stand for installation qualification, operational qualification and performance qualification. If you were to add a VIDA data collection device, it would be fully installed by a member of the technical team, or they would guide you remotely through the installation set-up. Installation has purposefully been made to be very simple and easy for anyone to follow, meaning it is very easy to comply to this guideline.


  1. Consider using data collection technology.

By using a piece of data collection technology such as VIDA, you can ensure 100% accuracy and traceability across your electronic records. The metadata gathered by VIDA will enable your workplace’s compliance with 21 CFR Part 11. It will allow your older lab equipment to maintain compliance, without having to upgrade them to newer models. It’s important to note that compliance is ongoing and must be maintained and upkept consistently.


Contact us today on +44 (0)1207 290 266 to find out more about how VIDA could help you comply to 21 CFR Part 11!

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