I have worked in numerous industries over the years implementing MDM, data quality and governance solutions for my clients, including Healthcare Distribution, Software Sales, Manufacturing, HR Services, Insurance, and Pharmaceuticals. In these experiences, implementing MDM solutions within validated systems has proven to be among the most challenging, with a unique set of considerations and processes that must be understood and carefully managed throughout the project lifecycle. Properly navigating through the compliance process and satisfying the validation requirements is a top priority, which can be achieved by understanding some key factors that will be critical to project success.
Validate What?
A “validated system” is essentially a system that is routinely audited by regulatory bodies such as the FDA, SEC or IRS. The degree and nature of these audits can be targeted at everything from the data within the system to the actual implementation processes, testing procedures, and standard operating procedures (SOP) that were followed while building the system. Validated systems are often found in highly regulated industries, such as Pharmaceuticals, Healthcare and Banking/Finance.
Although every company and industry has their own distinctive set of processes and regulatory compliance guidelines that need to be considered, here are the Top 7 Key Success Factors for implementing MDM within a validated environment:
- Planning, planning… and more planning
Proper planning is always key for any project, no matter the company or industry. It’s not news that successful projects employ strong project leadership, and build detailed plans that take into consideration the defined scope as well as any contingency-adding variables. It is the case that with validated systems every document (user and functional requirements, all design specifications, every individual test case, installation procedures, validation plans…) must go through a very formal and stringent document lifecycle. This can add weeks, if not months, onto the project timeline. The plan must be built and managed to a very granular level, allowing the Delivery Manager to account for document review and approvals, accurately estimate project phases and quickly identify timeline risk. - Understand Compliance and Validation Policies and Procedures Up-Front
Ensure that project leadership is well versed in validated systems implementations. Having the experience and battle scars that comes from having “been there and done that” can pay large dividends as the project marches on. However, even with experienced project leadership it is essential to meet with the company’s Compliance and Validation Managers at the very onset of the project and walk through the nuances of all related processes and procedures. Schedule weekly checkpoints with Validation/Compliance Managers to keep them close, and proactively address any compliance issues before they become a bigger problem late in the project. - Preparation and Execution of Validated Testing Cycles
In validated systems implementations, systems in the production environment are not the only ones subject to audits and comprehensive compliance oversight. QA is also a validated environment, and everything from the test plan, test cases, test data, to the code itself has to be validated and approved before it can be moved into the QA environment. After the necessary approvals, the testing cycles are very rigid in their execution. Even an error/typo in the test case is cause for filing a formal discrepancy and can have schedule impact. Preparation is the best way to mitigate this risk, along with having seasoned Test Leads for functional and user acceptance testing that can guide the teams through an efficient testing phase. - Avoid Outside Project Deadlines
If possible, proactively work through all major scope decisions and validation requirements ahead of time. A final, all-inclusive list of deliverables needs to be compiled based upon these validation requirements, and clearly recorded within both the project charter and the official project plan. Significant changes to this list during the course of the project could make or break your ability to deliver on-time and under budget. The importance of compliance will almost always trump other timeline determining factors, so a deadline that is set in the absence of awareness of the validation requirements will not be met. Avoid a project deadline that is determined by outside factors, and make sure that the scope of system functionality, deliverables and validation requirements are what ultimately drive the final go-live date. - Build Documentation Approvals and Phase Gates into Plan
It is crucial to build the entire document lifecycle into the project plan for every deliverable. This includes all phases of document completion; beginning with the initial draft, initial-review, final draft, circulation for pre-approval, and formal signatures and approval. Often, companies have their own documentum systems which manage the workflow and version management of these documents. The validated system methodology often requires formal approval of most documents within the documentum system in order to proceed from one phase gate to the next; for example, transitioning from the Analysis to Design or from the Build to Testing phases. The time involved for each step of the lifecycle can significantly disrupt the timeline if not properly accounted for in the plan. - Working Through the Defect Resolution Process
Similar to the documentation lifecycle, the defect resolution process in validated system testing can be much more rigid and formal than is typical. From the initial logging of the defect, it is imperative to have a dedicated Delivery Manager to spearhead the process of investigation, bug fixing and unit testing, documentation updates/reviews/approvals, code migration and re-test. It is also critical to build multiple defect resolution cycles into the plan before the project timeline is set in stone. It is not enough to plan for general testing cycles for functional, defect re-testing and regression. In addition to traditional testing cycles, having detailed defect resolution sub-cycles with several anticipated code pushes built into the plan will ensure the team doesn’t find itself swimming upstream against the validated testing process. - Training for Project Resources
Validation process and SOP training is not only a good idea, it is often mandatory. Ensure this is part of your onboarding plan for all consultant and client resources. When developers, testers and project managers truly understand and are trained on the compliance and validation processes they must adhere to, it can drastically decrease project risk.
If these key success factors are understood and utilized during the project lifecycle, achieving all-around success in a validated systems implementation is certainly possible. Don’t resist; instead, embrace the validation process by taking proactive planning measures to make the project more efficient rather than reacting later to compliance enforcement.
Steve Ruff is a Senior Consultant at Infoverity, serving as a Delivery Manager and Integration Architect on project engagements. For more information, he can be contacted at SRuff@Infoverity.com.
Steve Ruff
Senior Consultant
SRuff@infoverity.com
