Achieving FDA Title 21 CFR Part 11 Compliance with CMMS Software in Life Sciences Industries
Industries regulated by the FDA (U.S. Food and Drug Administration) must follow a strict set of standards intended to protect consumers’ health and safety achieving FDA Title 21 CFR Part 11 compliance. FDA Title 21 CFR Part 11 is an important policy that outlines the requirements for electronic recordkeeping for organizations in the life science industry that do business in the United States. Because of the complexities and nuances of the policy, manufacturers can think they are achieving 21 CFR Part 11 regulatory compliance only to find that they are not.
The following guide explains the requirements for 21 CFR Part 11 compliance and how life sciences maintenance teams can achieve compliance by leveraging an effective Computerized Maintenance Management System (CMMS) software within pharmaceuticals, medical device manufacturing, lab equipment maintenance, and more.
What is 21 CFR Part 11 Compliance?
CFR (Code of Federal Regulations) 21 is the policy governing manufacturing standards for organizations whose products are regulated by the FDA. Part 11 of the regulation, released in 1997, specifically establishes the criteria for ensuring that electronic records are as reliable and trustworthy as paper records. 21 CFR Part 11 requires regulated businesses to make sure electronic records and signatures are “trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper” (CFR Part 11.1 (a)).
To maintain, sign, and submit FDA documents digitally, a process familiar to research sites and sponsors, knowing Part 11 is essential.
21 CFR Part 11 compliance is the state of being officially recognized as compliant by the FDA. Businesses can use their organizational systems, controls, and processes, in combination with software to optimize their compliance–for example, implementing a system by which employees are required to record their maintenance work digitally, and utilizing a software that records actions and establishes controls in a manner that adheres to 21CFR Part 11.
Maintenance software, like Computerized Maintenance Management System (CMMS) software or Enterprise Asset Management (EAM) software, can be a powerful partner in the quest for 21 CFR Part 11 compliance. A CMMs or EAM can provide features like a detailed audit trail, data security, and password-protected electronic signatures.
Achieving compliance with Part 11 is the responsibility of businesses – but having the right maintenance software can make the difference when it comes to being ready for auditors and confident in your compliance.
What is the History of 21 CFR Part 11?
As digital recordkeeping became more commonplace starting in the 1980s and 1990s, recordkeeping technologies came with both benefits and risk factors. Electronic records enabled fast information exchange, made it possible to quickly search and retrieve records, and reduced errors through automated data collection and recording.
However, electronic records often failed to measure up to the reliability and authenticity standards of traditional paper-based records. For example, electronic records are easier to falsify compared to paper records. Title 21 CFR Part 11 solved this problem by outlining clear standards for how electronic records are logged, validated, traced, and stored.
Why is 21 CFR Part 11 Compliance Important?
The consequences of not complying with Title 21 CFR Part 11 are significant for manufacturers. For one, compliance is mandatory for any company that seeks to sell their products in the United States. Failing to meet compliance standards can also lead to an operational shutdown, costing valuable production time while concerns are resolved.
Beyond the costs of non-compliance, 21 CFR Part 11 plays a key role in digital recordkeeping security. The regulation ensures data integrity, so that practices are in place to verify the authenticity and confidentiality of digital records. It also makes sure the right tools are in place to retrieve essential data and documents.
When it comes to establishing controls over key actions, 21 CFR Part 11 requires both operational and security controls. Regulated businesses are called to build automated workflows that guide processes through a safe and logical sequence, and to restrict users to only appropriate actions within digital platforms.
Maintaining a detailed history of actions and changes is also essential to 21 CFR Part 11 – an audit trail that provides traceability for users’ actions, so that supervisors can review what changed, when, and who performed the change.
A last vital role of 21 CFR in electronic recordkeeping security is in validation: the documentation of how processes should work, and testing to validate functions are as expected.
Which Industries Must Comply with 21 CFR Part 11?
Title 21 CFR Part 11 applies to pharmaceutical companies, biotechnology institutions, medical device manufacturers, cosmetics companies, and more. It applies to all FDA-regulated industries, as well as businesses that provide raw materials for retail distribution. It also includes the use of operating lab equipment for research and development. Other regulated businesses and organizations include research sites, clinical trial sponsors who are performing FDA-regulated research, and Clinical Research Organizations (CROs). Clinical research personnel working on FDA-regulated studies, along with personnel involved with purchasing digital recordkeeping systems or software, should know the fundamentals of 21 CFR Part 11.
A technology platform does not necessarily require validation. Defining how you will use the platform is important to understanding whether you need to be considering 21 CFR Part 11 compliance. What actions will your team perform with the platform? Will the platform be handling or changing electronic records, the integrity of which needs to be safeguarded? Will your team be signing electronically to approve key actions?
Do your research to ensure your digital documentation is compliant.
4 Key Areas to Ensure 21 CFR Part 11 Compliance
The FDA conducts audits on facilities using a comprehensive checklist that marks internal systems for security, traceability, valid use, and reference purposes. While not an exhaustive list, the following are four key areas to focus on when reviewing your 21 CFR Part 11 compliance and preparing for an audit:
1. Validate Controls and Procedures
Title 21 CFR Part 11 states that internal systems must be validated to ensure they are accurate, reliable, and consistent. To protect security and access controls, only authorized personnel should be allowed to operate the system to sign production records, update existing documentation, and open core files or directories. If unauthorized access to the database is detected, immediate action must be taken to report the incident to a security unit or IT manager.
2. Establish an Audit Trail
The 21 CFR Part 11 checklist requires that manufacturers are able to produce accurate, complete, and time-stamped records of changes made to the system during normal operation, including creating, modifying, or deleting files. To ensure traceability, organizations must also be able to produce copies of previous audits at the FDA’s request.
3. Follow Electronic Signature Requirements
Electronic signatures must have the signer’s name, the signed date/time, and the “reviewed” or “approved by” indicator. Real names are required and cannot be substituted with job titles. Likewise, the signature must be attached to a specific document. Companies should also avoid mixing up electronic signatures on digital documents and scanned signatures on physical copies, as scanned signatures are not considered electronic records.
4. Retain Complete and Accurate Copies of Inspection Results
The 21 CFR Part 11 compliance checklist explains the need for producing accurate and complete copies of files in multiple formats. These must be stored in a secure system to serve inspection and review purposes. A robust system should support multiple file types, including PDF, XML, or SGML. Records should be stored and ready for retrieval throughout the duration of a record’s retention period, defined by a “documented risk assessment and a determination of the value of the records over time” (FDA).
How an Efficient CMMS Helps with 21 CFR Part 11 Compliance
To facilitate compliance, organizations are implementing computerized maintenance management system (CMMS) software for core capabilities such as:
- Assigning user permissions
- Centralized document and data storage
- Tracking work orders
- Logging equipment and inventory
Just having a CMMS does not automatically guarantee compliance with 21 CFR Part 11, but an effective life sciences CMMS does provide the tools and functionality to help achieve compliance.
To comply with Title 21 CFR Part 11, your CMMS should provide the following capabilities to protect the reliability, completeness, and authenticity of your digital records:
- Management of digital signatures with multiple levels of approval
- Access to records of maintenance activities, including time-stamped records of modifications and revisions
- Strict security and data privacy, including restricting user access and permissions
Contact us today to learn how a life sciences CMMS can help with 21 CFR Part 11 compliance.
