Complying with the 21 CFR Part 11 standard is essential for organizations in FDA-regulated industries that use electronic records and electronic signatures. This regulation ensures the integrity, reliability, and security of electronic documents and forms a crucial part of regulatory compliance. In this article, GOL Solutions will guide you through the key steps and strategies to effectively meet the 21 CFR Part 11 requirements, helping your organization maintain compliance and streamline operations within the legal framework set by the FDA.

What is 21 CFR Part 11 standard?

21 CFR Part 11 is a critical regulation issued by the U.S. Food and Drug Administration (FDA), which sets the standards for using electronic records and electronic signatures within regulated industries. Compliance with this regulation is mandatory for organizations that choose to maintain records or submit required documentation electronically in lieu of using paper records and handwritten signatures. Here’s a detailed breakdown to understand the standard better:

Implementation and Scope

• Electronic Records as Official Records: Organizations can replace paper records with electronic ones and handwritten signatures with electronic signatures, provided they adhere to the standards specified in 21 CFR Part 11.
• Submissions to the FDA: Electronic submissions must meet the regulation requirements and should be prepared as specified in public docket No. 92S-0251, identifying what the FDA accepts in electronic form.

Controls and Security Measures

• For Closed Systems (with restricted access controlled by responsible parties): There must be specific controls to ensure authenticity, integrity, and confidentiality of electronic records. This includes system validations, audit trails, system access limitations, and use of secure electronic signatures.
• For Open Systems (where access isn’t controlled by content responsible parties): Similar controls are required with additional measures like encryption and the use of digital signatures to maintain record security from creation to receipt.

Electronic Signatures

• Uniqueness and Security: Each electronic signature must be unique to the individual and not reusable by or reassigned to anyone else. For non-biometric signatures, two distinct identification components are required, such as an ID and a password.
• Biometric Signatures: These must be set up to ensure that they are not replicable and are unique to the individual user.

Operational Protocols

• Certification to the FDA: Organizations must certify to the FDA that their electronic signatures are intended to be the legally binding equivalent of handwritten signatures.
• Signature Components and Controls: Covers specifics on how electronic signatures should be managed and authenticated, ensuring they are protected against unauthorized use.
• Password and ID Management: There must be stringent controls to maintain the security and integrity of identification codes and passwords.

By adhering to these regulations, organizations can ensure their electronic documents are managed in a secure, efficient, and compliant manner, thus upholding the integrity and confidentiality necessary for FDA-regulated activities. This regulation not only supports modern digital operations but also enforces stringent standards to protect data and verify identities in the healthcare and pharmaceutical sectors.

Who is required to be compliant with 21 CFR Part 11?

Compliance with 21 CFR Part 11 is required for any organization in industries regulated by the FDA that chooses to use electronic records and electronic signatures instead of paper-based documents and handwritten signatures. These industries include:

• Pharmaceutical Companies: Manufacturers of prescription drugs and over-the-counter medications.
• Biotechnology Firms: Companies involved in the research, development, and production of biological products.
• Medical Device Manufacturers: Organizations that produce medical equipment and devices.
• Dietary Supplements Companies: Manufacturers and distributors of nutritional and dietary supplements.
• Food and Beverage Industries: While less commonly impacted by Part 11, companies in these sectors may be affected when they conduct regulated research or submit certain documentation to the FDA.
• Clinical Research Organizations (CROs): Entities that conduct clinical trials must ensure that their data handling processes for electronic records comply with Part 11 when the trials involve products regulated by the FDA.

These entities must ensure that their electronic data handling systems are capable of producing records and signatures that are trustworthy, reliable, and equivalent to paper records and handwritten signatures. Compliance helps in ensuring data integrity, security, and traceability within regulated environments.

How to achieve compliance with 21 CFR Part 11?

Achieving compliance with 21 CFR Part 11 involves implementing a comprehensive set of practices and technologies that ensure the integrity, confidentiality, and reliability of electronic records and signatures. Here’s a structured approach to ensure compliance:

Conduct a Gap Analysis

Begin by assessing your current systems and processes to identify any gaps between existing practices and the requirements of 21 CFR Part 11. This includes evaluating how electronic records and signatures are created, modified, maintained, archived, retrieved, and transmitted.

Implement System Validation

Validate all computer systems used to handle electronic records to confirm their ability to produce accurate and reliable results. This process should verify that the systems can consistently perform as expected and adhere to approved specifications and functional requirements.

Ensure Secure and Unique Electronic Signatures

Implement measures to ensure that electronic signatures are secure, unique to the individual, and linked to their respective electronic records. Ensure that the signatures cannot be repudiated and are as legally binding as traditional handwritten signatures.

Establish Robust Audit Trails

Enable secure, computer-generated, time-stamped audit trails that record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit trails should be designed to ensure the traceability of actions and changes without obscuring or deleting the original data.

Limit System Access

Control access to systems managing electronic records to authorized individuals only. Use secure login processes, including two-factor authentication or biometric verification, to strengthen access controls.

Maintain Data Integrity and Security

Ensure that electronic records are accurate, legible, contemporaneous, original, and attributable (commonly referred to as ALCOA principles). Implement data protection measures such as encryption and regular backups to safeguard data against loss, corruption, or unauthorized access.

Develop SOPs and Training Programs

Create and maintain standard operating procedures (SOPs) that cover the use, maintenance, and auditing of electronic records and signatures. Provide training to all relevant staff to ensure they understand their responsibilities under 21 CFR Part 11 and how to operate in compliance with the regulations.

Regularly Review and Audit Compliance

Regularly audit your systems and processes for compliance with 21 CFR Part 11. These audits can be conducted internally or by external experts. The insights gained from these audits should be used to continuously improve compliance practices.

Document Everything

Keep thorough documentation of all systems validations, audits, training records, and policy changes. Documentation should be readily available and capable of supporting regulatory review and inspections.

Implement Continuous Improvement

Compliance with 21 CFR Part 11 is not a one-time event but an ongoing process. Regularly update systems and processes as technologies and regulatory requirements evolve.

By following these steps, organizations can ensure that their use of electronic records and electronic signatures meets the stringent requirements set by the FDA under 21 CFR Part 11, thereby supporting regulatory compliance and enhancing the reliability and security of their digital records.

How can GOL help you comply with the 21 CFR Part 11?

Utilizing GOL’s expertise and technology solutions can offer several benefits in achieving compliance with 21 CFR Part 11:

• Tailored Compliance Solutions: With over two decades of experience in providing technology solutions for the logistics industry, GOL understands the complexities of regulatory compliance. Their expertise allows them to tailor solutions specifically designed to meet the requirements of 21 CFR Part 11, ensuring that your electronic records and signatures adhere to FDA standards.
• Comprehensive e-Compliance Services: GOL specializes in e-logistics, e-compliance, and e-government solutions, making them well-equipped to address the unique challenges faced by companies in maintaining compliance with regulatory standards such as 21 CFR Part 11. Their comprehensive services cover aspects ranging from registration with the US FDA to market standard consultations for food, cosmetics, medical devices, and pharmaceuticals.
• Proven Track Record: With a vast client base of over 5000 companies, GOL has demonstrated its ability to deliver effective trade compliance and supply chain management solutions. Their track record speaks to their reliability and proficiency in assisting organizations across various industries in achieving and maintaining regulatory compliance.
• Expert Guidance and Support: GOL’s team of experts offers valuable guidance and support throughout the compliance process. Whether it’s navigating the intricacies of FDA regulations or implementing technology solutions to ensure compliance with 21 CFR Part 11, their knowledgeable professionals are available to provide assistance every step of the way.
• Streamlined Processes: By leveraging GOL’s technology solutions, companies can streamline their compliance processes, reducing manual effort and minimizing the risk of errors or oversights. GOL’s efficient systems help organizations manage electronic records and signatures in a manner that aligns with FDA requirements, enhancing overall efficiency and productivity.

Overall, partnering with GOL can provide companies with the expertise, technology, and support needed to effectively comply with 21 CFR Part 11 and other regulatory standards, thereby mitigating compliance risks and fostering business success in the highly regulated environment of the logistics industry.