The process of ensuring compliance with 21 CFR Part 11 has always been a challenge for life science companies, as it requires unquestionable evidence that the organization is following the FDA regulations in this regard. Even with the use of a Quality Management System (QMS) software, compliance for digital signatures and documentation for FDA 21 CFR Part 11 can be complicated, as you still need to dot your i’s and cross your t’s while keeping your documents safe and secure. Your entire team needs to understand how to manage and handle documents and signatures.
The first step of any Part 11 compliance program is to perform an assessment of your current system to determine what is needed to bring it into compliance with FDA expectations. To ensure compliance, you will need to identify current areas of risk and adhere to key components of compliance. As we all know, validation will always have a lasting impact on the quality of your product, and there are criteria that must be met to ensure that your quality system documents are secure and authentic. For example, to ensure that you’re safe from audits and potential compliance issues, you need to establish clear audit trails within these systems or a series of records that demonstrate you are following FDA regulations and guidelines.
These trails will provide specifics to document your quality management and product development processes to protect from potential audits. To ensure that you’re creating an acceptable audit trail, your system must address certain requirements, such as retrievable audit trail, availability of previously recorded information, and availability of a formal change control procedure for system documentation that maintains a time-sequenced audit trail for those changes made by the organization.
In addition to creating an audit trail, you also need to ensure that your electronic compliance technology will provide copies of your records, as the FDA requires that these copies are easily accessible to one of their representatives. To ensure that your system can provide the copies of records necessary to remain compliant, you want to make sure that the system can produce accurate and complete copies of electronic records on paper.
Another critical aspect of achieving 21 CFR Part 11 compliance is securely storing old and original records and signatures. According to the FDA, you should base these records on predicate rule requirements. While the FDA does not require these records to be electronic, they require that the “records should preserve their content and meaning,” which is difficult to do with paper records.
At Synergy Bioscience, our experts are current on all the latest trends and have the expertise to provide your organization with robust computer system validation documents that will withstand the regulatory scrutiny of the FDA inspectors.
Our assessment reports are thorough and detailed with specific per system recommendations. We do not take a simple check list approach, but instead determine the aspects of the system that pose regulatory or product quality risk and how to solve those issues. We can help you determine how to use a risk-based approach to prioritize your computer system validation projects as well as write the Master Plans, protocols, and final reports required.