Top 3 Challenges of GxP Software Deployment (And How to Solve Them)

GxP software must meet stringent regulatory requirements. With new development methodologies and platforms available, deployment of any new system in a GxP environment is going to include challenges, so it’s important to plan ahead to overcome those challenges for a successful launch.

Here are three of the most common challenges you will encounter, along with some suggestions for overcoming them:

1) Integrations: Technical and process challenges are inherent in integrating modern systems with their older counterparts. Legacy systems often lack proper documentation and rely on siloed, manual configurations, and workflows.

Solution: Plan for robust validation efforts, and use Infrastructure as Code (IaC) to ensure that system setups are the same across legacy, testing, and live environments.

2) Data Migration and Audit Trail Integrity: Moving historical records, audit logs, and time stamps without loss of information is a common struggle. These errors can affect traceability and data integrity.

Solution: Robust trial mitigation (e.g., risk management plans, simulated actions) followed by full reconciliation and timestamp verifications on transformed data prior to launch ensures audit trails are validated.

3) User Preparedness: When users lack training or an understanding of the benefits and expectations for the new system, they may reject or misuse it, leading to deviations in progress and compliance issues.

Solution: Accurate, complete, and timely training, with hands on walkthroughs of the new system prior to deployment; and feedback sessions with the users following deployment to continue to evolve effective training and workflows.

Software deployment in a GxP environment comes with critical regulatory requirements, and meeting those requirements successfully requires mitigation of as many challenges as possible. Starting with plans to address the most common challenges will put you one step closer to a strong and successful deployment.