For life sciences organizations, CFR Part 11 is a regulatory requirement for validating authenticity, integrity, and confidentiality of electronic records and electronic signatures. A compliance checklist for 21 CFR Part 11 thus plays a significant role in enabling an organization to become and stay compliant with FDA regulations, mitigate risk, and meet required standards around electronic documentation.

This guide describes the main elements of a CFR Part 11 compliance checklist and how you can streamline your compliance process.

What is 21 CFR Part 11?

21 CFR Part 11 is an FDA regulation that outlines the requirements for managing electronic records and electronic signatures. It makes sure that records created, modified, maintained, or transmitted electronically possess at least the same degree of trustworthiness, reliability, and integrity as paper-based records. This regulation affects companies operating in industries under FDA oversight, including pharmaceuticals, biotechnology, and medical devices.

The companies that need to become 21 CFR Part 11 compliant should strictly adhere to a comprehensively defined system that can address all the fundamental regulatory issues with regard to system validation, audit trails, user access control, and electronic signatures. In order to fully understand how far along your organization is in terms of complying with the principles of the Part 11 guideline, feel free to refer to the following checklist:

CFR Part 11 Compliance Checklist

1. System Validation

a. Has the system been validated? All the electronic record systems must be validated, ensuring the sanity and accuracy of data.

b. Are records retrievable in a timely manner during the retention period? Electronic records shall be archived in such a way that they can be accurately retrieved quickly to enable their review, examination, or auditing by authorized persons during their retention period.

c. Does validation use a risk-based approach? FDA recommends the use of a risk-based approach to ensure the validation is representative of the influence the system provides to product safety and data integrity.

d. Does the system allow access only to authorized people? For data integrity and security, a system should provide access to only authorized users.

e. Does it highlight any invalid records or records that have been tampered with? To assist your organization in keeping compliant, the system must identify records that are tampered with or invalid.

2. Audit Trails

a. Is there a secure, time-stamped audit trail? The system has to generate audit trails automatically. Audit trails should record events such as creation, amendment, or deletion of records.

b. Are audit trails implemented for critical records? Critical records are those where the FDA’s guidance requires audit trails. The checklist has to ensure that the organization identifies and applies audit trails where it’s necessary.

c. Are audit trails retrievable throughout the record retention period? It is imperative in this that audit trails will be made accessible for review throughout the life of the record.

d. Are audit trails available for FDA review and copying? There must be a system to accommodate the exportation or copying of audit trails, when requested, by FDA investigators.

3. Electronic Signatures

a. Are electronic signatures unique to individuals? Each individual electronic signature shall be assigned to, and used by, one individual only and shall not be reassigned to, or used by, another person.

b. Is the identity of the individual to be assigned electronic signatures authenticated before assigning electronic signatures?: Before an electronic signature can be used, the identity of the individual must be properly verified.

c. Are electronic signatures applied only where necessary?: According to the FDA guidance, electronic signatures should be used only when necessary, based on predicate rules.

4. Record Retention

a. Does the system generate accurate copies of electronic records?: The system should be able to generate accurate and complete copies of records that are in an electronic format as well as on paper, as required by the FDA.

b. Does record retention strategy pertain to both electronic systems and paper-based systems?: In the case of hybrid systems, the checklist should check if the record retention policies are at least equivalent for electronic and paper records.

c. Are there procedures for the management of user access when an employee terminates?

d. Systems should have procedures for record access revocation in cases of employee role change or termination from the company.

An intelligent and comprehensive policy for compliance can help reduce a lot of the manual effort in keeping compliant with the regulation while helping detect errors that could be costly to the organization.

How to Create an Effective Compliance Policy for Part 11?

There are a variety of innovative solutions that organizations can leverage to build a powerful end to end policy for compliance with the Part 11 regulation. A few solutions that have become a standard in the industry include:

Automated Audit Trails: Automatically generate detailed audit trails based on the various actions performed by the users of an organization, such as date, time, user ID, and action type.

Electronic Signatures: Record electronic signatures; all signatures must be attributed to the proper users while meeting FDA requirements of dual-factor authentication.

System Validation: Automated data capture in a way that reflects the regulatory requirements for accuracy and integrity of data.

Data Security: The security features of the platform involve encryption and password management that ensures sensitive data is well protected against unauthorized access.
Further security is provided by password aging and account lockout after retries.

Why a Checklist is imperative for compliance

A 21 CFR Part 11 compliance checklist becomes a very important tool in the process of any organization that operates electronic systems to handle FDA-regulated data. It quickly shows points of risk, corrective actions to be performed, and general compliance for all areas dealing with electronic record management. It minimizes non-compliance risks by ensuring audit trails, electronic signatures, and access controls are in place, thus enabling an organization to pass any inspection by the FDA with ease.

Who is CIMCON Software

CIMCON Software has been helping hundreds of clients with compliance of pharmaceutical regulations like CFR Part 11 for over 25 years. Through our experience, we have perfected controls that provide the functionality we recommend above to keep your documents secure and mitigate the risks discussed in this article. That is why we count 8 out of the Top 10 life science companies as our customers. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe, CIMCON can support your implementation at a single site or across the enterprise.

For life sciences companies, CFR Part 11 compliance is a regulatory requirement that ensures the authenticity, integrity, and confidentiality of electronic records and electronic signatures. The 21 CFR Part 11 compliance checklist plays a crucial role in helping organizations adhere to the FDA regulations, reducing risks, and meeting the required standards for electronic documentation.

This guide outlines the key components of a CFR Part 11 compliance checklist and how leveraging solutions like CIMCON’s eInfotree Excel Desktop can streamline your compliance efforts.

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation issued by the FDA that governs the management of electronic records and electronic signatures. It ensures that records created, modified, maintained, or transmitted electronically meet the same standards of trustworthiness, reliability, and integrity as paper-based records. This regulation applies to companies in FDA-regulated industries such as pharmaceuticals, biotechnology, and medical devices.

For companies to achieve 21 CFR Part 11 compliance, it is essential to maintain a well-defined system that addresses key regulatory requirements like system validation, audit trails, user access control, and electronic signatures.

Key Areas of a CFR Part 11 Compliance Checklist

1. System Validation

• Is the system validated?: All systems managing electronic records must be validated to ensure they function as intended and preserve the integrity of the data.
• Are records readily retrievable throughout their retention period?: Electronic records must be stored in such a way that they can be easily retrieved for review or audits during their required retention period.
• Is a risk-based approach used for validation?: The FDA recommends using a risk-based approach to ensure that the system’s validation reflects its impact on product safety and data integrity.
• Does the system ensure access is limited to authorized individuals?: Only authorized users should have access to the system to maintain data security and integrity.
• Can invalid or altered records be identified?: It is essential that the system can flag any tampered or invalid records to maintain compliance.

2. Audit Trails

• Is there a secure, time-stamped audit trail?: The system must automatically create audit trails that record actions such as the creation, modification, or deletion of records.
• Are audit trails implemented for critical records?: According to the FDA’s guidance, audit trails are only required for critical records. The checklist should ensure that the organization identifies and applies audit trails where necessary.
• Are audit trails retrievable throughout the record retention period?: It is critical that audit trails remain accessible for review throughout the record’s lifecycle.
• Are audit trails available for FDA review and copying?: The system must provide the capability to export or copy audit trails during FDA inspections.

3. Electronic Signatures

• Are electronic signatures unique to individuals?: Each electronic signature must be linked to an individual and must not be reused or reassigned to another person.
• Does the system use at least two identification components for electronic signatures?: Electronic signatures must use dual-factor authentication, such as a password and identification code, to ensure security.
• Is the identity of the individual verified before assigning electronic signatures?: Before an electronic signature can be used, the identity of the individual must be properly verified.
• Are electronic signatures applied only where required?: According to the FDA guidance, electronic signatures should be used only when necessary, based on predicate rules.

4. Record Retention

• Is the system capable of producing accurate copies of electronic records?: The system must be able to produce accurate and complete copies of records, both digitally and on paper, when required by the FDA.
• Does the record retention strategy apply to both electronic and paper-based systems?: For hybrid systems, the checklist should ensure that record retention policies apply equally to both electronic and paper records.
• Are procedures in place to manage user access when employees leave the organization?: Systems must include procedures for revoking access to records when employees change roles or leave the company.

Benefits of Using CIMCON’s eInfotree Excel Desktop for 21 CFR Part 11 Compliance

Ensuring CFR Part 11 compliance in environments where spreadsheets are used for GxP (Good Practice) applications can be challenging. CIMCON’s eInfotree Excel Desktop provides a solution by simplifying the process through automation and secure data handling. Here’s how this tool helps ensure compliance:

• Automated Audit Trails: The eInfotree Excel Desktop automatically captures detailed audit trails for every action performed, recording data such as the date, time, user ID, and type of action. This ensures compliance without the need for manual tracking.
• Electronic Signatures: The tool supports the use of electronic signatures, ensuring that all signatures are linked to individual users and meet FDA requirements for dual-factor authentication.
• System Validation: With eInfotree, you can maintain system validation with automated data capture, ensuring that the data is accurate and consistent with regulatory requirements.
• Data Security: The platform offers encryption and password management features to ensure that sensitive data is protected from unauthorized access. Password aging and account lockout after retries add further security.
• Record Retention: The system supports the storage and retrieval of both electronic and paper records, simplifying the process of record retention for audits and inspections.

Why a Checklist is Essential for Compliance

A 21 CFR Part 11 compliance checklist is a critical tool for any organization using electronic systems to manage FDA-regulated data. It helps identify areas of risk, implement corrective actions, and maintain compliance across all aspects of electronic record management. Ensuring that audit trails, electronic signatures, and access controls are in place minimizes the risk of non-compliance and enhances the organization’s ability to pass FDA inspections.
Using a tool like CIMCON’s eInfotree Excel Desktop can further streamline compliance efforts, saving time and reducing the potential for human error. Automated features like audit trails and electronic signature management ensure that the system meets FDA requirements while maintaining data integrity.

Conclusion

CFR Part 11 compliance is essential for life sciences companies operating in regulated industries. A thorough compliance checklist is a powerful tool to ensure your organization is meeting the necessary standards for electronic records and signatures. With the right systems and processes in place, companies can not only maintain compliance but also enhance the efficiency of their operations.

By utilizing a solution like CIMCON’s eInfotree Excel Desktop, companies can automate their compliance processes, ensuring data integrity and security. The CFR Part 11 compliance checklist is more than just a formality; it’s an essential part of ensuring operational efficiency, data security, and regulatory adherence.