The Medicines and Healthcare products Regulatory Agency (MHRA) are constantly updating and changing requirements to ensure medical devices and medicines supplied in the UK are safe and fit for purpose.
Your business needs agile processes, complete visibility and a collaborative approach in order to respond rapidly to any changes.
Our software provides you with an integrated management system so that compliance can underpin every decision made, every process is properly recorded and risks are identified before it impacts your product. With free end users and unlimited supplier portals, you can be confident in your approach and demonstrate best practice throughout your business.
Best of all, we provide a complete validation package so you’ll have a validated product from day one and a proven validation methodology which will help ensure your systems and processes move with the times.
Audit trails and workflows
Our system records everything so when an auditor or customer visits you can demonstrate just how organised, proactive and diligent your business truly is.
Collect risk data from across your business.
Real time reporting enables your business to act faster and make stronger, collaborative decisions.
Track supplier performance over time and monitor any changes to products and supplies provided.
Plan and manage training in a central system. No more messy spreadsheets.
Document important information such as your Trial Master File (TMF). Our software provides a robust framework for good documentation control.
Learn about our five-phased approach to managing computer systems validation, and how we help you to comply with regulations and Standards such as ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, Eudralex Volume 4 Annex 11, and the EU Electronic signatures directive.
Don’t just take our word for it. See all the great results our customers have achieved using our software.