Early GxP system validation: the key to project success
Summary
If new digital capabilities and top-notch data are critical to process efficiency and competitive advantage, it makes no sense to leave validation (proof that they fulfil what’s required) until the latter stages of the project lifecycle, say Ulrich Lein and Stefani Godoy Herrera of MAIN5.- Author Company: MAIN5
- Author Name: Ulrich Lein / Stefani Godoy Herrera
- Author Email: Stefani.herrera@main5.de / Ulrich.lein@main5.de
- Author Website: http://www.main5.de
Any systems relevant to GxP (‘good practices’) must be validated as fulfilling their intended purpose. Yet, too often, computer system validation (CSV) or assurance (CSA) is treated as a distracting compliance exercise, when it could be used to ensure strategic benefits – such as seamless data sharing, and repurposing of data across functional boundaries.
The alternative is projects not delivering and having to be reworked, at great expense and delay. Ultimately, it could mean patients failing to gain prompt access to safe, high-quality products.
Consider these pointers to get more out of validation:
1. Apply it early
Optimising the beneficial impact of CSV or CSA starts with early action, ideally when organisations start thinking about a project or the introduction/change of a system. Validation should be budgeted for as part of the project.
2. All needs and potential issues should be anticipated up front
Validation should be directed by someone with a holistic interest in the new project’s success, with input from subject matter experts across all affected departments.
Too often, issues don’t arise until after an inspection. EMA and FDA findings are made public too, so there could be reputational damage if systems are found not to comply with regulatory expectations. Quality management systems (QMSs) have been the focus of recent waves of inspections, , evidenced by recent warning letters published by the FDA. This is increasing the urgency around ensuring a continuous validated state.
3. The right intentions matter
Although validation approaches must move with the times, the CSV vs CSA debate has been a distraction. Think of any guidelines as ‘recommended best practice’, focus on the essence of the provisions, and be pragmatic and flexible where necessary. Early collaboration between validation and IT teams can help with this, to pre-empt any issues and determine the associated level of risk and provisions.
4. The total cost of system ownership is the real project cost
The Good Automated Manufacturing Practice (GAMP) community estimates that if companies approach validation pre-emptively and with the right intent it should account for 10 per cent of the overall project budget. If neglected, it will cost considerably more. That’s even without the impact on any indirect co-dependencies, the increased risk, or the cost of missed benefits.
The total cost of system ownership is that of achieving a successful operational system that does what it promised - once live, and over time.
5. Link validation to the choice of supplier
Finally, choosing the right supplier will further boost the likely success and validation of a project’s output. Consider, too, that the bigger and more globally dispersed the organisation, the greater the need for agreed structure around how systems work and how data is defined, to overcome undesirable variances across user groups.
