Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice) should be defined, maintained and continuously improved.
The definition and replication of GxP across a business depends on your ability to build a robust Quality Management System. And this QMS needs to be accessible and maintained by your workers, as well as easily auditable by regulators.
In a med tech development process, quality systems should help you:
- Document GxP requirements
- Control GxP activities
- Record indelible evidence that GxP has been maintained
In practical terms this means maintaining the integrity of data and documentation through
- Real time filing and indexing of key documentation
- Verifying and validating quality procedures
- Managing change control
- Publishing key documentation
- Managing and archiving records
- Managing retrieval systems
- Supporting future auditing processes
Given the complexity and shifting demands of a typical med tech development project, paper-based systems are likely to struggle to keep up with these demands, increasing the risk of non-compliance and project failure. But DIY digital solutions stitched together with Excel, Dropbox and Outlook, are just as likely to fall apart under the pressure.
Choosing an eQMS should give workers the integrated digital tools they need to create and maintain a QMS which is an ‘accessible and definitive source of truth’ around their company’s GxP.
These are the capabilities you should be looking for in a system to ensure the consistent delivery of quality across your operations.
9 ways the right eQMS software can help you maintain GxP compliance
- A good digital eQMS gives you the tools to define and document your SOPs in ways that make them understandable and relevant to your workers. The best eQMS helps you graphically map out SOPs, supporting written documentation with videos and photos to show what is expected. It locks these documents down for editing, but allows for them to be easily updated, subject to required change control procedures
- Helps establish and impose change control procedures while automatically recording version histories of critical quality documentation. The right software will ensure GXP documentation is up-to-date and all changes are approved by key stakeholders The system will notify users when approvals are required and track the history of changes for future auditors
- Supports hierarchies of document access and editing privileges. These features protect information against unauthorised access and change, ensuring data and documentation integrity
- Offers high level of authentication around changes and sign off on business-critical documentation. For example, it should support the best practice use of electronic signatures (FDA 21 CFR Part 11) promoting complete traceability and accountability in all your organisational decision making
- CAPA - A good eQMS will support the effective management and documentation of corrective and preventive actions. There are extensive GxP requirements around the way a businesses should proactively monitor for non-conformities in products and update their procedures to prevent their reoccurrence
- Supports the validation of Computerised Systems - a digital QMS can assist with the formal organisation of the validation process, storing and indexing the documentary evidence for verification and validation of the systems you deploy
- Auditing capabilities - Preparing, storing and managing your records and documents using the principles of GDocP - a good QMS will ready you for inspection and auditing by external bodies
- A good EQMS will help you embed GxP throughout your organisation. Maintaining a process-driven intranet is a key way in which procedures and documents can be made easy for workers to access and contextualise
- Continual Improvement. Sharing and publishing GxP requirements across an organisation helps everyone define, review and refine best practice - improving their effectiveness and the quality of end products
GxP compliance is all about having the ability to implement (and prove you have implemented) all the controls identified as necessary for the delivery of a reliable, safe and usable end product or service.
Compliant businesses mitigate the risk of product failure (and, therefore, harm to consumers) through consistent process definition, training, procedural control and record keeping around all their working practices.
The right eQMS will give you the tools to manage and maintain all these responsibilities.