One of many systems, but the eQMS is the most important
Many systems and tools are available to help life science companies manage their business, but the eQMS is one of the most essential systems to ensure companies comply with regulatory requirements. Regulations are primarily about documenting what you are going to produce and the process of doing it. And you have to prove to the FDA that you have mitigated any risks in your processes and products. This means ensuring that colleagues are using the latest approved version of a standard operating procedure (SOP) or material safety datasheet. Or certifying that the relevant people are trained and authorized. The easiest way to do that in today's digital world is to do it electronically. And a modern eQMS has the features and capabilities to help you.
For instance, when the FDA conducts an audit, the auditor often evaluates certain aspects:
- The staff understands documents: with eQMS functionalities such as electronic signatures, the employees can sign the “read and understood” statement. This verifies and gives your organization traceability from the eQMS that staff have performed training as expected.
- Documents are where they are supposed to be in the system with the correct approved version accessible to the relevant users: the eQMS manages and traces documents and provides authorization of users based on profiles and responsibilities.
- Operators know the settings for a production unit: the eQMS helps manage and document training and certification of staff.
The eQMS is particularly useful to comply with 21 Code of Federal Regulations (CFR) Part 11, which includes validation, time stamps, maintenance of electronic records, and electronic copies. And, of course, the audit report is stored in the eQMS.
Staying focused on areas of improvement – and linking it all together with the eQMS
The eQMS can capture customer complaints which could trigger an FDA warning letter if not handled correctly. With the eQMS, you can trace if someone has responded, if the complaint is routed to the right people or if your colleagues should elevate the complaint to a full Corrective Action And Preventative Action (CAPA). The proper departments are involved in analyzing what went wrong and working on how to fix it. This procedure will generate new documents for the CAPA, and all actions spin off into other documents. The eQMS provides full end-to-end traceability and links it all together.
Validating quality in the eQMS
Another critical aspect of the regulatory requirements is validating your processes to adhere to 21 CFR Part 820. This pertains to current good manufacturing practices (CGMP) for medical device manufacturers. For example, the FDA will want to see proof that you have validated whatever you said you were going to do. It could be your production process and your systems. What did you test? What did you use as your script? What were the results? What did you do as a consequence of the results? The answers to these questions result in validation reports to ensure quality, and the eQMS helps manage this process.
The foundation for continuous improvement
Your whole organization can take advantage of the features and capabilities the eQMS offers to continuously improve your organization and product: management of documents, risks, training, audits, CAPAs, and support for other quality processes. Everyone can use the eQMS which helps align all aspects of the organization and product. For example, the eQMS keeps you prepared and organized for audits with regulatory content ready and accessible. And if you are well prepared to meet regulations, you can deliver your product faster to the market without compromising quality.
