What is 21 CFR Part 11?
Title 21 CFR Part 11 is the portion of the Code of Federal Regulations that provides standards established by the Food and Drug Administration (FDA) for the use of electronic records and electronic signatures. With electronic records widely used in the Life Sciences industry, most companies will find FDA 21 CFR Part 11 applicable.
Part 11 helps companies safely maintain data securely so that it is not lost or corrupted, ensures companies are implementing systems and software correctly, makes sure there are data-trace changes and prevents falsified records.
Benefits of 21 CFR Part 11 Compliant Software
Data Integrity and Security
21 CFR Part 11 compliance maintains the integrity of electronic records and signatures to ensure that data is accurate, reliable, and complete. Incomplete or inaccurate data records can lead to issues of quality or safety concerns for patients.
Ensure compliance with FDA regulations and other international agencies to avoid non-compliance that can lead to warning letters, fines, or shutdowns. Avoid negative impacts on an organization’s reputation by committing to 21 CFR part 11 compliance.
Efficiency and Productivity
Streamline workflows and processes with adequate electronic record-keeping and signatures to improve productivity and efficiency. Automating tasks reduces the risk of manual errors and benefits document review and approval processes.
CFR 21 Part 11 compliance reduces the risk of fraud, data tampering, and unauthorized user access to sensitive information. Implementing controls and procedures highlighted in Part 11 assist in mitigating risks and ensures sensitive information is secure.
Part 11 compliance ensures electronic records are stored, archived, and retrievable for the needed retention period to meet legal and regulatory requirements. Part 11 mandates comprehensive audit trails that track all actions related to signatures and electronic records, providing a clear and detailed account of who accessed, deleted, or modified records.
Global Market Access
Countries outside of the U.S. experience smoother market entry and expansion into international markets by recognizing the importance of electronic record integrity by committing to 21 CFR Part 11 requirements.
Trust and Credibility
Companies that demonstrate 21 CFR Part 11 compliance exemplify a commitment to the safety, quality, and integrity of their data. By promoting standardized processes, a company can enhance its reputation and competitiveness in its industry.
21 CFR Part 11 Guidelines
The 21 CFR Part 11 guidelines established by the FDA pertain to the use of electronic records and electronic signatures in the medical device, pharmaceutical, and biotechnology industries. The goal of the guidelines is to ensure the integrity and reliability of electronic records and signatures. The key standards and guidelines of 21 CFR Part 11:
21 CFR Part 11 applies to FDA-regulated industries that implement electronic records required to be maintained by regulations and submitted to the FDA. Systems must have controls to ensure authorized users only have access to electronic records and involve authentication, role-based access, and password procedures. Secure and time-stamped audit trails must document any changes to electronic records and are regularly reviewed.
Electronic signatures must be unique to each individual user, and security controls are used to ensure their security. 21 CFR Part 11 requirements describe the use of electronic signatures and handwritten signatures executed on electronic records to ensure they are as secure as handwritten signatures on paper.
Life science companies that implement open systems (non-proprietary computer systems) must have additional controls to ensure electronic records are secure and meet integrity standards.
Electronic records of paper records must be validated as accurate and complete representations of paper records. Ensure the effectiveness of operating procedures by adhering to software validation principles.
Electronic records must be retained and easily retrieved throughout their required retention period so that they can stay protected from any loss or change.
Electronic records must be protected from unauthorized alterations by using secure, time-stamped audit trails and controls to prevent unauthorized changes.
Providing adequate training to personnel prevents electronic records from unnecessary changes by implementing procedures and processes that reflect 21 CFR Part 11 standards.
What are the Key Components of 21 CFR Part 11?
The key components of 21 CFR Part 11 compliance include all electronic records of data and information created, modified, archived, or transmitted electronically. Electronic signatures are included and used to highlight approval, authorization, or consent on electronic records. Electronic systems used to create, archive, and modify electronic records must be validated to ensure systems are reliable, accurate, and concise.
What is 21 CFR Part 11 in Pharma?
In the pharmaceutical industry, 21 CFR Part 11 pertains to aspects of drug development, manufacturing, quality control, and clinical trials. Part 11 mandates the implementation of access controls that restrict system access to authorized personnel to help protect sensitive pharmaceutical data. Part 11 also applies to electronic records and signatures implemented in clinical trials, ensuring data integrity and regulatory compliance in pharmaceutical processes.
What is the difference between open systems and closed systems in the context of 21 CFR Part 11?
Defined by 21 CFR Part 11, open systems are not designed for regulated environments like the pharmaceutical industry. Open systems are general-purpose systems and software that most likely do not have the intent of being used in regulated processes and are usually commercially available. Since they are not developed with 21 CFR Part 11 in mind, they require additional controls to ensure Part 11 compliance. Software validation, security measures, and documented processes are necessary to meet regulatory requirements. Closed systems are specifically designed for use in regulated environments. Their features align with Part 11 requirements and still require proper maintenance while reducing the need for extensive validation and controls.
What are the requirements for electronic signatures under 21 CFR Part 11?
Electronic signature processes involve having unique user identification to ensure signatures are compared to specific individuals. Password protection verifies the identity of the signer and should be kept confidential to prevent unauthorized access. Secure electronic signature binding makes it clear that the signature is the act of the appropriate individual. Signature authentication puts controls in place to ensure electronic signature authenticity by including identifiers for each signer and mechanisms to verify identities. Audit trails are records of any changes or processes related to electronic signatures, including who signed, when, and any additional changes or deletions of records.
How long do electronic records need to be retained under 21 CFR Part 11?
21 CFR Part 11 does not specify a required retention period for electronic records and is usually determined by other applicable regulations or internal policies. CGMP (Good Manufacturing Process) regulated companies like pharmaceuticals typically set a minimum of two years to include protection and control records. Clinical trial records are usually retained in accordance with applicable regulations governing clinical trials. Laboratory records requirements are subject to 21 CFR Part 58, which includes Good Laboratory Practice (GLP) regulations.
What security measures are required under 21 CFR Part 11?
Unique user identification, role-based access control, and password policies.
Time-stamped records of action that include details of who performed what activities.
Data encryption, data backup and recovery, and access restrictions to prevent unauthorized access, ensure data availability, and protect against data loss.
Ensures electronic systems create, modify, maintain, and archive electronic records accurately and reliably.
What training measures are required under 21 CFR Part 11?
21 CFR Part 11 does not have specific training requirements, but it does require individuals involved in electronic records and signatures to be trained to understand the responsibilities and procedures related to electronic records and signatures. Roles and responsibilities should be properly defined, security measures should be placed, and users should be trained on the proper use of electronic signatures. It is essential for life sciences to implement training programs that are tailored to their necessary processes and systems. The training should be adequately documented and recorded to demonstrate regulatory compliance.
What are the penalties for non-compliance with FDA 21 CFR Part 11?
The FDA issues warning letters to regulated organizations that are in violation of Part 11. A formal notice from the FDA indicates an organization is not in compliance with regulatory requirements, outlines the specific violations, and requires corrective actions within a set timeframe.
Fines and Penalties
The FDA may impose fines and civil penalties for not adhering to regulatory requirements highlighted in 21 CFR Part 11. The fines may vary but can be substantial if the violations are serious.
Product Recalls & Injunctions
If electronic records or signatures associated with manufacturing, quality control, or clinical testing are unreliable, the FDA will implement product recalls or injunctions to halt the production or distribution of affected products.
Loss of Regulatory Approval
Failure to comply with Part 11 jeopardizes the ability to maintain regulatory approval for an organization’s products. In effect, an organization risks severe reputational damage in its industry, loss of business opportunities, and increased regulatory scrutiny.
How does 21 CFR Part 11 compliance affect electronic records and electronic signatures?
21 CFR Part 11 establishes electronic records and electronic signatures as the legal framework for paper records and handwritten signatures, declaring that electronic records are legally equivalent to any handwritten document. Record-keeping and approval processes have more flexibility and efficiency with established protocols for electronic records and signatures.
How does 21 CFR Part 11 compliance relate to other global regulatory standards?
ICH E6 (R2) Good Clinical Practice (GCP)
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides global standards for clinical trials. Compliance with Part 11 further ensures data integrity and security in electronic records for global clinical trials.
ISO 13485 (Medical Devices Quality Management Systems)
ISO 13485 sets a global standard for medical device manufacturers and their quality management systems. Compliance with Part 11 assists medical device companies in meeting requirements for electronic records, a critical component for international market access.
PIC/S GMP (Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practices)
Countries that adhere to PIC/S GMP incorporate data integrity and record-keeping requirements that help pharmaceutical manufacturers adhere to 21 CFR Part 11.
EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
The European Union’s MDR and IVDR require data management and traceability that aligns with Part 11 and its strict integrity of electronic records and signatures, which is essential for devices in CE Marking and to achieve market access in Europe.
What industries or sectors are most affected by 21 CFR Part 11 compliance?
The Pharmaceutical industry adheres to 21 CFR Part 11 compliance to support research, development, manufacturing, quality control, clinical trials, and regulatory submission of drugs. Biotechnology is subject to Part 11 and works closely with pharmaceuticals in research and development. Medical devices include simple tools and complex equipment and are subject to Part 11 requirements.
Who must comply with 21 CFR part 11?
Regulated companies with documents or records in electronic format must comply with FDA 21 CFR part 11. Part 11 pertains to pharmaceutical companies, manufacturers of medical devices, biotechnology companies, CROs, biologics developers, and other companies regulated by the FDA.
How does 21 CFR part 11 apply to your company?
Even if your Life Sciences company relies on paper records, as soon as you upload a document to a server, your company must comply with 21 CFR Part 11. Under FDA regulations, 21 CFR part 11 applies to electronic records used as a digital representation of information that is maintained, created, modified, archived, distributed, or retrieved by a computer system. Even if your company relies on a paper system, validation is needed to confirm that the electronic copies match the paper records.
How do you become 21 CFR Part 11 compliant?
To support 21 CFR Part 11 compliance, data security measures like password standards should be in place to ensure the appropriate people have permissions to sensitive data. Clear audit trails should demonstrate creation, modification, or deletion to show traceability to the FDA. Implement 21 CFR part 11 guidelines on electronic signatures and ensure the FDA is aware of their use. Validate installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) to ensure software compliance. Always remember that FDA 21 CFR part 11 compliance is always the responsibility of Life Sciences companies, not the software platform.
Why Arbour Group for 21 CFR Part 11 Compliance
Arbour Group 21 CFR Part 11 compliance checklist assessment and remediation services help clients ensure that electronic records and electronic signatures are trustworthy, reliable, generally equivalent substitutes for paper records and traditional handwritten signatures and that those functions are in conformance with the requirements of 21 CFR Part 11 compliance.
Arbour Group's extensively trained professionals evaluate a client's use and documentation of electronic records and electronic signatures as governed by applicable regulatory requirements. The result of a 21 CFR Part 11 compliance checklist and assessment determines the effectiveness of a client's process within a highly regulated environment and suggests appropriate remedial actions as necessary.
21 CFR Part 11 Compliance focuses on six critical areas:
- Impact of 21 CFR Part 11 on the client's computer systems, including Quality Management Systems
- Identification of the client's computer systems and operating environment
- Hosting and interpretation of user interviews
- Review and consideration of client procedures
- Analysis of procedural documentation, validation, and audit data
- Regulatory significance of the computer systems
Arbour Group can give our clients an unmatched, in-depth, and thorough inspection of their systems and procedures. We ensure compliance with the requirements of 21 CFR Part 11 through our years of experience and solutions that are unique to you and your company's needs.
To learn more about Arbour Group's 21 CFR part 11/Annex 11 services in Europe, contact us today.
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