SimplerQMS has more than 30+ years of experience implementing software in life science companies. We are ready to help, no matter if you are about to build your QMS, already have a “paper-based” QMS on a file drive or if your QMS is fully digital.
We use the following proven process, which ensures quick and thorough implementation. Thereby, we deliver a validated system, under change control and which runs on a qualified data center ready for regulatory audits and inspections.
“We have approached other eQMS vendors, but none of them had the nessesary knowledge about the regulatory requirements in our industry. SimplerQMS speaks and understands the same ‘regulatory language’ as us. Furthermore, their ISO 13485:2016 certification is an important stamp of approval.”
– Malene Schrøder, CEO of Fluisense
- Review your current Quality Management System content
- Perform a GAP analysis by comparing your current content with the formal regulatory requirements
- Review current document types, templates, existing quality manual, SOPs, Design History Files and other relevant documentation
- Walk you through configuration decisions which are documented in a user requirement specification
- Capture requirements for migration of existing documentation to SimplerQMS
SimplerQMS is configured according to the user requirement specification including future document templates. A test version of SimplerQMS is made available for your users with agreeded security settings.
TRAINING & TEST
- We train your users in system access and all processes related to their job function.
- After training is completed the users participate in testing of the system.
- When all tests are passed with no critical issues, the production system is released. This completes the validation activities.
- All validation deliverables are archived and change control is enforced for both the test and production system.
- Migration of documents from the Quality Manual, Design History Files and other relevant documentation.
- All documents go through a review and approval flow which creates the document baseline for SimplerQMS.
- When SOP’s are approved, training activities are automatically created based on employee job functions.
- We recommend that a formal audit is executed by an external auditor checking for regulatory, QMS and planned project activity completeness.
- The project is closed when planned project activities are completed and no critical issues are unsolved.