Opinions expressed by CSols Inc. contributors are their own.
In this blog, Charlie examines the Computer System Assurance initiative from the U.S. Food and Drug Administration (FDA) against the long-established CSV approach. For more blog information from Waters experts, click here: blog.waters.com.
No more validation.
CSV is a thing of the past.
These are just some of the attention-grabbing headlines I’ve seen in various blogs and LinkedIn posts over the last 12 months about Computer System Assurance (CSA), and the reality couldn’t be more different.
The U.S. FDA originally targeted their Case for Quality initiative (2011) at improving medical device quality and usability for patient safety. More recently, FDA’s Center for Devices and Radiological Health has sponsored an industry pilot team1Grateful thanks are given to the members of the CSA industry team whose materials this blog has leveraged. under the CSA title to improve Computer System Validation (CSV) approaches, as the existing practices were identified as a barrier to the adoption of new technologies.
But, really, how much difference can there be between Validation and Assurance?
Underneath all the hype and excitement, in practical terms, CSA is fundamentally the risk-based approach promoted by the FDA in 2003 and applied to CSV by GAMP 5 in 2008. We’ll look at the pros and cons of the current CSV methodology and understand where industry has failed in applying critical thinking and risk-based approaches.
By understanding the CSA principles, we can then move on to embrace the benefits of CSA, such as:
Additional Reading: CSV is Not a Commodity
Properly applied, CSV uses a documented risk assessment to focus effort on the highest-risk system functionality, and uses scripted testing to demonstrate that those risks are mitigated by the system configuration and applied controls. It provides documented evidence that the system is fit for its intended use within a regulated environment and will protect patient safety, product quality, and data integrity.
That’s what properly applied CSV achieves. The issues I’ve encountered too many times over my career in CSV include:
These issues are not failings of the CSV risk-based approach so expertly laid out in ISPE GAMP 5; rather they are failures of industry to apply this approach effectively.
CSA requires the use of critical thinking, whereby facts are analyzed impartially to identify patterns, to assess trends and theories, and to evaluate outcomes.
This critical thinking should be combined with the risk-based approach to ensure the focus of effort is on the system, software, or function that can directly impact patient safety, product quality, and data integrity. Understanding of the potential impact is aided by defining the business process and data flows, and assessing the risk based on the overall business process, not just on an individual step in a system; e.g., are there further controls downstream that would highlight an error that occurred?
The key to CSA is that credit is given for all testing, including:
Test activities must add value to the assurance that the system is fit for purpose. Test efficiency can be further enhanced by:
The FDA Case for Quality program started with Medical Devices, but the CSA approach is now being applied successfully to computerized systems used in other regulated areas, e.g., pharmaceutical organizations.
In the context of a Chromatography Data System – used in a pharma QC lab with a high direct impact on patient safety and product quality – CSA would allow the focus to be on:
A combination of ad-hoc unscripted testing for error guessing and intended use verification, and robust scripted testing to demonstrate reliability for the highest-risk items, would be used for these functions.
Potentially the application views and menu navigation, the ability to create custom summary reports (which are neither original records nor complete data and therefore should not be used for decision-making), the management of pre-defined reasons, and other typically lower risk functionality, will leverage the supplier development testing. If standard functionality has been adequately tested by the supplier, there is no need to repeat any testing for those aspects. The need for any additional scripted testing can be evaluated by considering factors such as simplicity/complexity, novelty, detectability, and degree of configuration or customization, as well as any process-specific risk factors.
Computer System Assurance is not a replacement for, nor a contradiction of, current Computer System Validation approaches as defined in GAMP 5 but rather a reinforcement, or restatement, of the GAMP 5 key principles of product and process understanding, quality risk management, and leveraging supplier activities. CSA combines risk-based testing with risk-based documentation. It is the risk-based approach “on steroids”, and my hope is that CSA provides the momentum for regulated companies to finally, effectively, embrace that risk-based approach for the ongoing safety of their patients.
Do you believe that less documentation will result in a lower quality of validation?
Would you feel confident to face a regulatory inspection with formal test documentation covering mainly the high-risk functionality, with limited scripted testing or even no testing of other functionality?