The main purpose of 21 CFR Part 11 is to ensure that these electronic records and electronic signatures are as trustworthy and reliable as their traditional paper equivalents. This means that companies need to have systems in place that limit user access and privileges, including unique usernames and passwords for each user, the ability to detect and prevent unauthorized system access, and processes for locking compromised accounts.
For small-sized and early-stage companies, understanding and complying with this regulation is essential. It is important to note that the FDA does not provide a “one-size-fits-all” solution, and companies must develop their own system for compliance. And there are multiple ways to approach this depending on resources and needs.
Implementing an eQMS
An Electronic Quality Management System (eQMS) is a key tool in achieving compliance with FDA 21 CFR Part 11. This system manages and controls documents, processes, and tasks to maintain quality assurance. The reason for the rise of eQMS over paper-based Quality Management Systems is because it better aligns with the requirements and expectations of modern businesses. By offering flexibility, facilitating remote collaboration, simplifying global regulatory compliance, and enabling data-driven decisions, eQMS is paving the way for businesses to maintain high-quality standards while navigating the complexities of the digital age.
Here are some points to consider:
- System Validation: To make sure that the eQMS is working properly, it needs to be validated. This involves testing all parts of the system, like data security, backups, and recovery functions. Additionally, you should think about how those systems could affect the accuracy, reliability, integrity, availability, and authenticity of necessary records and signatures.
- Data Integrity: The system must have security measures in place to prevent unauthorized access or tampering with the data. This includes unique usernames and passwords for each user, and processes for locking compromised accounts.
- Audit Trails: The eQMS must have automatic audit trails for actions related to electronic records. This ensures traceability and accountability.
- Electronic Signatures: The system must enable the use of electronic signatures that are connected to their corresponding electronic records. These signatures should have date and time stamps and be considered equivalent to handwritten signatures, initials, and other necessary signatures as per the applicable rules.
Compliance on a Budget
To achieve compliance, many companies leverage an Electronic Quality Management System (eQMS). This system manages and controls documents, processes, and tasks to maintain quality assurance. Implementing an eQMS involves considering system validation, data integrity, audit trails, and electronic signatures. The company has several options for building the system: they can use their internal IT and Quality team, they can hire external consultants with more expertise, or they can look for eQMS platforms that offer both tools and expert services.
For startups operating on a tight budget, the cost of implementing an eQMS might seem intimidating. However, there are ways to navigate the compliance process at a low cost. Leveraging online tools like Google Drive for document management, DocuSign for electronic signatures, investing in team education and training, and conducting regular audits can aid in maintaining compliance. To ensure compliance, it’s important to involve all stakeholders and have a clear understanding of the FDA requirements that apply to the company’s operations. Establish a system that includes requirements, procedures, work instructions, and relevant records to meet the 21 CFR Part 11 requirements and any applicable predicate rules.
However, for those startups that have some budget to spare, turn-key eQMS platforms are available. These platforms provide a comprehensive solution to manage all aspects of quality management. They typically charge an annual fee based on the number of users and offer features such as integrated training, change control, system validation, electronic signatures, documentation&record control, limited system access to authorized individuals, and audit trail. Examples of these platforms include MasterControl, Greenlight Guru, and Qualio.
Case Study: A Startup’s Path to Compliance
Let’s illustrate this with a hypothetical case study. MedTech Innovations, a medical device startup, leveraged Google Drive for document storage and management, and DocuSign for electronic signatures. They faced challenges in maintaining an audit trail but overcame this by relying on the version history feature in Google Drive, and by keeping detailed records of the changes.
To ensure compliance with 21 CFR Part 11, MedTech Innovations focused on user access control and system security. Access to quality documents and records on the Google Drive system is restricted to authorized personnel only. They must use their employee account with a protected password to log in and review, edit, or approve these documents. They set up a comprehensive training program for their personnel so that everyone had an understanding of the applicable regulations. The team also conducted regular internal audits to check whether all processes were in accordance with the FDA requirements.
However, as MedTech Innovations grew, they found managing their compliance activities through disparate systems cumbersome. After assessing their budget and needs, they decided to invest in a turn-key eQMS platform. This platform streamlined their quality management processes, made audit trails easier to maintain, and improved their overall compliance status.
Conclusion
In conclusion, whether you’re a bootstrapped startup leveraging low-cost online tools, or a small company investing in a comprehensive eQMS platform, compliance with FDA 21 CFR Part 11 is achievable.
Ultimately, compliance with 21 CFR Part 11 is not just about meeting regulatory requirements; it’s about ensuring product quality, safeguarding patient safety, and maintaining a strong reputation in the marketplace.
Lab-2-Market Consulting provides regulatory compliance solutions for medical device companies, specifically tailored to their needs. Our regulatory specialist can offer assistance with system validation, data integrity, audit trails, and electronic signatures, all while taking into account the complexities of 21 CFR Part 11. Contact us today for a free consultation and to take the first step towards compliance for your company.
Reference
- FDA. (2003). Part 11, Electronic Records; Electronic Signatures – Scope and Application. U.S. Food & Drug Administration. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
