Audit Management
Plan ahead with an Audit Program
For the smoothest possible audit experience, experts agree: prepare, prepare, prepare.
With Aligned eQMS you are in an excellent position to provide compliance proof of your continuously consistent QMS state with minimal effort.
Set up an Audit Program and plan all audit types well ahead in one central location. Consolidate internal, external, and supplier audits under one unified view.
Built-in compliance proof — with created audit programs that stand up to regulatory scrutiny with a documented, repeatable process.
Prepare smart, execute efficiently
With seamless access to previous findings and real-time QMS data, the planning and execution of targeted audits can be conducted with minimal effort and maximum impact.
Gather QMS artifacts automatically by pulling relevant documents, records, and previous audit results directly from your eQMS.
Drive insight-based audits by using past performance and recurring issues to guide where and how you audit.
Act on Audit Results and turn findings into improvements
Respond swiftly and systematically to audit findings by recording nonconformities, initiating corrective actions, and monitoring progress in real time.
With a clear action plan, you assign tasks, owners, and deadlines to make sure no audit finding is left unresolved.
Provide solid proof of continuous improvements through compliant records of audit result control, while monitoring sign-offs of completed follow-ups.
Genuine Voices, Tangible Results
Genuine Voices, Tangible Results
Amazing to see how adaptable AE is to our development process and risk management process, giving us the ability to work swiftly without any unnecessary constraints!
Jaimin Patel
Thanks to the Linked projects-feature, we are able to reduce the duplication of module documentation to a minimum.
Christoph Karthaus
I can sincerely recommend Aligned Elements to any Medical Device company looking for a single tool to manage requirements, specifications, risks and design reviews.
Victor Steinacher
Aligned Element have made life easy working with requirement/verification including traceability. We could easily make a structure suitable for us, for all our different products and their specifications.
Anna Norlander
Aligned Elements supports a structured way to, starting from requirements, create a traceable set of documentation through the whole lifecycle.
Claes Nilsson
We benefitted by being able to create risk analyses for various product groups quite quickly and easily. We could now focus more on the content, and leave the form to the system.