Once you have completed your Quality Management System (QMS) gap analysis your next step will be to update and add to your documentation set as needed. We can’t stress enough at this stage that developing your QMS does not need to be a huge undertaking, and the focus should be on fit for purpose, pragmatic and usable documentation.
The Fastest Route to a Compliant QMS
Once the QMS assessment and gap analysis has been performed, the third step in our five step process is to make the updates to the QMS documentation. As we described in step two, these documents are typically in the following formats:
- Working Practice Documents
- Job Descriptions
In some cases we are also looking at training materials, although these do not typically form part of the QMS, but need to be in accordance with the processes laid out in the QMS.
All documentation will be reviewed with the customer in draft format before being updated and finalized.
Quality documentation may need review with SOP owners, stakeholders, operations teams and QA before we can be sure it is ready to be finalized. TRI will facilitate the review and ensure the QMS can be finalized with confidence.
Why Use TRI?
Having already performed a number of QMS updates for the purpose of ICH E6 (R2), TRI have the skills, experience and assets in order to make your updates as quickly and efficiently as possible. If you follow our blogs at all, you will already know that our mantra is pragmatism and usability.
Having built a set of templates and sample SOPs, we can adapt these quickly for each client’s needs. New process areas such as Risk Assessment and Risk-Based Monitoring can be challenging to develop from the ground up. Having the knowledge that you have a complete, compliant set of QMS documentation will allow you to move forward into staff training and trail execution with confidence.
What Should I Do Next?
To contact us and find out how we are helping companies to prepare for ICH E6 (R2) and how we could help accelerate your route to compliance.