eQMS Implementation and 4 points to consider

Although numerous articles describe the standard procedures for transitioning from paper-based systems to an eQMS, and vendors of these systems provide valuable insights on their websites, it is important to consider several additional factors that may assist organisations in this new phase of their operational processes.

Most commercially available systems will involve a validation phase and customer onboarding as part of their service offerings. However, the starting point must be a User Requirement Specification defining the requirements of the system to meet the specific requirements of the organization. This should be generated by team members with appropriate experience or by leveraging external support.

Here are some additional points that may assist you in addressing previous challenges and ensuring alignment with your supplier in the phase preceding implementation:

Point 1 – Change Control

It goes without saying that the introduction of an eQMS in any organisation is a critical change in the operations and so must be managed and controlled accordingly. One of the first steps must be to raise a detailed change control establishing the pre and post implementation actions for the system, the action owners and any effectiveness checks that may be required. The change needs to be assessed by all stakeholders to verify that all potential areas of impact have been considered and documented.

Point 2 – Supplier engagement and experience

When engaging with your supplier, it is essential to ascertain whether they employ professionals with training and experience in the pharmaceutical industry. This inquiry is crucial to ensure that the engineering team is adequately prepared to address your questions during the implementation phase as it is important that these inquiries do not come as a surprise to them.

Point 3 – Sandbox testing

During the preliminary functionality checks of the system, typically conducted in a sandbox environment by the internal team, it is important to establish if the system is capable or replicating your internal process per your SOP.

Point 4: System support and Service Level Agreements/Quality Technical Agreements

It’s important to evaluate the response times for issues raised with the system (should any arise) and the methods used to request assistance from the technical team. While your vendor may offer information on response times based on different levels of complexity, it is advisable to specify such response times in one or both of a Service Level Agreement or Quality Technical Agreement.

MIAS has recently implemented its own eQMS for the management of all our internal systems. We are more than happy to share and discuss our experience and knowledge gained in order to support you on your eQMS implementation journey.