Ensuring CFR21 Part 11 Compliance with Precisa

The Code of Federal Regulations (CFR) 21 part 11 compliance ensures data integrity in a digital world for reliability, authenticity and integrity of all electronic records. Having laboratory balances that comply with CFR21 is vital to meet Good Laboratory Practices (GxP).

Key points

  • The purpose of CFR21 part 11 is to ensure data integrity in a digital world for reliability, authenticity and integrity of all electronic records
  • Compliments the GxP principles, as both revolve around data integrity
  • Ensuring electronic integrity includes having defined user profiles which are password protected, signatures, alibi memory and an audit trail within your balance.

What is CFR21 part 11 compliance?

CFR21 part 11 compliance is a set of rules outlined by the USA to ensure that drug manufacturers and other relevant companies comply to the same standards. This set of guidelines is aimed at providing guidance towards electronic documentation in laboratories and similarly controlled companies, but is still a standard that paper-based companies can adhere to.

How is CFR21 part 11 compliance different to other FDA data compliance?

CFR21 part 11 was introduced due to laboratories moving towards a digital way of storing data rather than the conventional paper-based method. Companies looking to comply with CFR21 part 11 will be looking to store their data digitally, whilst maintaining the same level of traceability and accountability of paper-based methods.

Why is CFR21 part 11 compliance important?

To ensure that all relevant companies adhere to the same quality standard, and that any code violations are detected and prevented in order to produce quality drug products that are safe and efficient.

An important aspect of CFR21 part 11 compliance is ensuring that you have a digital record that cannot be tampered with, so that you have a comprehensive log of all events leading to the creation, modification and deletion of data. This is achieved through an integrated audit trail within Precisa balances. Additionally, the alibi memory complements this system, and stores all weighing results digitally, which can be exported.

How does CFR21 part 11 link to GxP?

Both CFR and GxP are aimed at data integrity and security, but they do have distinct differences.

CFR21 part 11 is a regulation established by the FDA, which outlines guidelines to ensure compliance digitally. Whereas GxP is a set of quality guidelines and regulations to ensure consistency, reliability and uniformity within various disciplines.

Who is responsible for ensuring compliance?

Ultimately, everyone who works in a regulated lab which complies with CFR21 part 11 is responsible for ensuring that they comply.

Overall, management, such as the study director or lab manager are responsible to ensure that their team are complying, but each employee is responsible for themselves, to ensure the work they are completing meets these standards.

How do Precisa balances meet CFR21 part 11 compliance requirements?

Various key features have been developed to ensure you meet CFR21 part 11 compliance, such as user-specific profiles, integrated audit trail and alibi memory.

Overall, electronic data integrity needs to be ensured if you want to comply to CFR21 part 11, and due to many laboratories moving over to electronic records, it is vital to utilise laboratory equipment that will meet your needs.

How do you ensure data integrity digitally?

User-specific Profiles: All data generated should be attributable, and state clearly who performed the action and when. For compliance to CFR21 part 11, that means ensuring that electronic records are as accurate and reliable as their paper-based counterparts. To achieve this in a digital world, balances should have user-specific profiles which are password protected with the ability to individually set access rights. This allows individual permissions to be defined, with modifications to system settings limited to specific user roles.

Signature: It is essential for data to be attributable. With the series 390 and 520PT balances, a printout of results will include the username of the individual. Additionally, balances which contain an audit trail allow for the traceability of all data digitally, with the audit trail correlating with the username of the individual. Alternatively, you can print off your balance results, which allows the user to sign the relevant documents by hand for other series of balances such as the 360. Both of these methods allow for your data to be attributable and the balance can adapt to your laboratories requirements, depending on whether or not you require a signature digitally or on paper.

Alibi memory and audit trail: A key component of compliance includes data management and modifications, which means having a permanent, tamper-protected, time-stamped log of all events – this is also vital for GxP compliance. The general rule is, if it isn’t documented then you can’t prove it happened. Therefore, having an electronic log that allows the reconstruction of events related to the creation, modification or deletion of data means that you will always be able to prove what happened and when. To achieve this digitally, balances should have an audit trail. Additionally, alibi memory software stores all weighing results. These systems complement each other to ensure data integrity, which can also be exported onto a USB, ensuring safe data transfer which can’t be tampered with.

Precisa balances: which one is suitable for me?

This is dependent on your laboratory’s needs and application, and whether or not you require full digital compliance.

Precisa 390 balance range allows CFR21 part 11 compliance

To ensure complete digital compliance with CFR21 part 11, the Series 390 or 520PT balances are the ideal choice, due to their advanced features, allowing for full traceability, accountability and integrity. These features include:

  • User defined profiles
  • Integrated audit trail
  • Alibi memory
  • Ability to either digitally sign or print the results to sign by hand

Alternatively, if you do not require complete electronic compliance and have a smaller budget, the Series 360 balance is the ideal choice for your laboratory. Several of the innovative features are still included, allowing for password protected user profiles, as well as space for a handwritten signature to be added to result printouts.

To learn more about the Series 390 balance and its wide range of features, and our other range of products visit;

Series 390 Balances – Semi-Micro and Analytical Balances

Series 520 Balances

Suggested reading:

GxP Compliance and Techcomp Lab Products by Precisa

Good Laboratory Practice When Weighing