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:
In practical terms this means maintaining the integrity of data and documentation through:
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.
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.
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.
These features protect information against unauthorised access and change, ensuring data and documentation integrity.
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.
See how Cognidox can help you with your eQMS
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.
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.
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.
Maintaining a process-driven intranet is a key way in which procedures and documents can be made easy for workers to access and contextualise.
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.