Validation Killed the GxP Star
Similar to what video did to the radio star in the 1980’s, GxP system validation became king in the late 1990’s by enhancing the quality experience and forcing many systems to be replaced and retired. However, this well-intentioned journey of improvement slowly became bloated. Today, achieving and maintaining validation compliance can be an expensive and potentially paralyzing productivity killer, but does it need to be?
Let’s say your job, or at least one of your likely too many jobs, is being responsible for ensuring that one or more GxP systems are properly validated. So, you do what most good professionals would do…
Coordinate with all the key stakeholders to understand timing of the business and IT drivers for production use.
Liaise with the system implementation team (which perhaps you are also managing) to understand the implementation timeline and work backwards from the target production date to figure out how much time is available to complete validation.
Realize you don’t have enough dedicated staff to hit the date and work out arrangements with managers in the stakeholder groups to “borrow” them for no more than 4-8 hours per week for the project duration.
Refer to your SOPs and ensure the team is trained to follow the likely manual validation process.
Seek out current validation expertise for planning and oversight, which is likely not within your department.
Go team! Right?
Well, yes, but there are inherent challenges with that approach. Those people you are borrowing, for all their best intentions and manager’s time commitment agreements, have day jobs in which their overall productivity will suffer. Also, their validation project work is likely to be completed in fits and starts which is inherently inefficient. They end up spending a few additional hours of their time each week. Maybe they are charging your budget for their time too. Was that a planned expense 6 months ago when annual budgets were created?
Then there is the challenge of manually creating and managing deliverables. The user requirements, validation plans, test protocols, trace matrices, and validation summaries may have become the patchwork of many who have volunteered their best efforts to the great cause. Even with SOPs, work instructions, and templates in place, there’s always room for differences in styles of everyone’s work without sufficiently applied tools to enforce consistency. This creates inconsistencies, confusion, and churn.
Speaking of your SOPs, they probably have been reviewed and updated in the last 1-2 years. However, have they been revised under the critical eyes of validation industry SMEs to eliminate unnecessary effort while maintaining low risk? Are your validation SMEs providing sufficient oversight throughout the project and is the project staffed with experienced validation leads to ensure risk assessment, planning, and testing processes are executed properly? Have you considered updating them based on the much-anticipated FDA CSA approach?
Moreover, throughout the year many of your organization’s GxP systems will be subject to maintenance upgrades and/or enhancements, each of which will require validation. You knew that at budget time last year, so you planned for X number of validation efforts per Y number of existing systems. Unfortunately, in many cases the scope of those validation efforts will be greater than expected. Still, we do what we must to brute force our way through it. After all, this isn’t anything new. This is the way we’ve always done it.
But isn’t that the root of all the problems? Doing things the way we always have becomes increasingly ineffective as our organization’s GxP system validation needs grow while budgetary and timeline pressures squeeze us from the other direction. It’s time to optimize the way system validation efforts are managed and executed. It’s time for Virtua Pharma Technology’s Validation as a Service (VPT VaaS).
Essentially, we need to do more with less; including working smarter, not harder and leveraging every opportunity that current technology makes available to us. With VPT VaaS, timeline, effort, and the resulting costs for validation efforts decrease dramatically while simultaneously increasing the level of quality and compliance. With VPT VaaS, you benefit from:
An established and comprehensive solution for your validation needs – new systems, maintenance updates, enhancements, and retirements, whether planned or unanticipated
A proprietary framework leveraging best of breed automated tools resulting in at least 30% less time to validate local, regional and global systems over traditional validation methods
Quality and compliance from validation experts who wholistically understand regulated system implementation challenges and how to apply the latest rules/regulations, and provide guidance to save time/money while minimizing risk
Flexibility to adapt to your organization’s SOPs or to use VPT’s SOPs
Can advise and/or assist in updating your SOPs
End to end management of your validation projects, with pre-defined milestones and minimized levels of effort for you and your internal staff, allowing teams to focus their productivity on your organization’s primary mission
Fully integrated electronic management of all documents which is used to automatically generate and maintain all auditable documentation in a globally consistent style and format including: User Requirements, Risk Assessments, Validation and Test Plans, Test Protocols, Test Execution Results, Trace Matrices, and Summary Reports
Leveraging VPT VaaS will greatly reduce the time, money, and stress associated with all your system validation needs and become a low-risk, high quality competitive advantage for your business. VPT also offers technical system implementation services which can be combined with VaaS for even greater overall time and cost savings.
So, if you need to validate a new system, an existing system in need of remediation, or a maintenance release of any system whether planned or unplanned, contact Virtua Pharma Technology and say, “I want my GxP!”