Switching to a modern digital eQMS from a paper-based QMS will save a medical device start-up time and money by supporting virtual collaboration, digital signatures and automating your processes. Going digital on an eQMS can actually become a requirement. When your documentation history grows, in order to stay compliant with regulation, the cost of running a paper-based system becomes too high and the possibility of making mistakes will increase. The transition to a digital eQMS raises some concern and two topics we hear about are:
- Migrating historical documentation is too heavy a workload for a team focused on product development
- There is a compliance risk if migrated records are questioned on integrity
The key is to have a plan for dealing with your document history. This plan can either be created and executed by yourself or you can get help from external partners.
Planning the data migration
In most cases it makes sense to move all current valid documents into the digital system. Hereby, you will be creating one single digital repository of documentation and one process for preparing and maintaining your records digitally moving forward.
Deciding on how to handle your documentation history and what to migrate to your new eQMS is a central part of your migration plan.
The migration plan identifies your current documentation which could be Standard Operating Procedures, training records and parts or complete technical files/design history files of your medical device. Step one is to locate all files, create an index of all records and establish who is the document owner.
Companies moving from a manual QMS often have a blend of uncontrolled files in a file folder combined with printed copies with wet-ink signatures placed in paper binders. The paper binder records should be scanned to pdf format ready to be migrated to your eQMS serving as your baseline document. This is the formal starting point in your eQMS including the historical approval. The corresponding digital source copy e.g. in word format should also be migrated as this is the version you will use when preparing future versions of the record in your eQMS.
This detective work is valuable as you often identify missing documents and/or approvals which you have time to correct in your old QMS before migrating.
After establishing an initial overview of the history, you need to decide if documents are to be migrated as-is (typically your Design History Files) or if documents needs to change as part of switching to an eQMS. Examples of documents needing changes are Standard Operating Procedures like your document and change control procedures, that as part of the project changes, and there most be an action plan for implementing this change.
The migration plan also needs to specify the method for doing the actual migration. This can be an automated process, which has the capacity to migrate thousands of documents in minutes. Or it can be a manual process where a migration team handles a smaller amount of records manually using a normal user interface.
External resources can easily do most of the above-mentioned work. Your team will define the migration scope, find the records and review any proposals for procedure changes.
Testing your migration routine
Data integrity is a key topic as you need to establish proof that the records you migrated to your eQMS are valid and cannot be questioned later. This involves a test of your migration-plan and migration-routine to document that the migration did not change your records unintentionally. After finishing the migration, planned and actual data are compared, and a report of checks, findings and issues should be summarized. Needed corrections are done and retesting is carried out until all issues are eliminated.
Testing ensures you have control of both your content and the migration process. Furthermore, it ensures that you have documentation of your data integrity. A last important benefit is that you and your coworkers will see how your content and processes will be presented in eQMS at go live. This is done without actually going live – and where there is time for more training, which builds up your internal system and process expertise.
This part of the process can also be handled by an external partner, which can load all data in draft status. This means that your team will only be responsible for the final review and approval. The external team can also prepare the documentation of the test for your final approval.
Data migration – for real
The last action before going live on your eQMS is doing the final migration of documentation. This exercise is done as part of a cut-over plan which outlines all actions needed when switching from your current QMS to the eQMS. This is also the time where the migration of documentation is done to the production environment.
This exercise is a repetition of what was done during the test and most often runs without any surprises. Until the migration and cut over is completed successfully there is an opportunity to abort cut over and return to the current QMS. This ensures that you have control of when to switch to your new eQMS system. It also means that you can make sure all is in place before firing up your new eQMS.
It’s doable and value creating
Migration of your history to an eQMS is a must-have, doable and value creating activity. It must be done to establish your eQMS documentation baseline. It also forces an evaluation of your existing documentation -identifying potential gaps and errors that you have time to correct.
Testing the migration plan and routine shows you how the eQMS will present your content at go live. It also gives you an opportunity to evaluate if you are ready for a smooth and controlled transition.
Documentation of the migration plan, tests and actual results ensures proof of data integrity and that your migrated records can be accepted in a digital format.
Finally, you should consider if your team or an external partner should handle the time-consuming preparations, the testing and the proof of data integrity. The central tasks, which you and your team is responsible for is locating the records for migration, approving plans and progress and digitally reviewing and approving migrated records to a final state.
SimplerQMS is a Ready-to-use eQMS for Medical Device Startup’s. We help you take a shortcut to market access by getting the required processes, templates and records in an Electronic Quality Management System accepted by the regulatory authorities. We are 21 CFR Part 11 Compliant and Validated according to GAMP5. This means that you can rely on a QMS and DHF that runs 100% digitally. Get rid of the paper binders, save time and start working more efficiently. www.simplerqms.com