The FDA’s decision to induce a shift from CSV (Computer System Validation) to CSA came with many challenges in organizational enhancements. The focus on critical thinking over documentation was a significant shift from the norm, which brought with it an improved focus on testing, product quality, and most importantly, patient safety.
However, the companies interested in making this change must completely revamp their approach and practices – leading to increased costs, changing company attitude, and modifying training practices for employees.
However, the benefits of making the change to CSA far outweigh the costs. For instance, according to a test conducted by the Medical Device Innovation Consortium (MDIC)1 alongside the FDA, the benefits for companies that adopted CSA were:
- A 90% or higher reduction of errors in script and testers
- Time for validation was cut in half, or more, with an overall increase in implementation speed
- Lower project costs
- Higher quality and productivity
- An increase in time dedicated towards critical thinking versus documentation. 2
As important as it is to recognize the usefulness of CSA, it is also crucial to outline good practices for its transition. Namely:
- Evaluate the environment and validation processes. How much time is lost on planning, testing, documenting or on other areas related to assessment and resources?
- Leverage metrics to understand the current system environment. This is essentially a method to identify performance, costs, and time spent on validation based on a standard rubric. An easy way to make note of these metrics is to remember the four p’s: People, process, product, and project:
- People aspect – Measuring performance of team members in relation to objectives
- Process aspect – evaluating operation processes and identifying areas of improvement and consistency
- Product aspect – Identifying criteria that assist with research and development, manufacturing, marketing, and logistics to understand the success or failure of a product
- Project aspect – Measuring performance aspects associated with project management and control. Namely: quality, performance, cost, deadlines met or missed, and customer satisfaction.
- Build an organizational enhancement plan. How is the organization going to adapt to the changes brought by CSA? There will be substantial effects on product quality, documentation processes, and safety and operational efficiency.
- Ensure to carry out a vendor audit. This will help you determine whether the vendor’s documentation is up to par with the standard quality of SDLC (Software Development Life Cycle) and other IT processes. 3
Although there exist many smaller factors that actively affect the transition to CSA, creating a plan with the right communication and training programs – a preparation for change from the classical waterfall methodology to the modern agile methodology – is key to ensuring a successful transition. An important factor to note is the understanding of the concepts behind CSA. It’s crucial to note how it helps your organization through a focus on critical thinking, product quality, patient safety, and data integrity.
Bibliography:
- Understanding FDA’s CSA Guidance in the Context of Current Regulations and GAMP® | American Pharmaceutical Review – The Review of American Pharmaceutical Business & Technology
- Computer Software Assurance Alliance (CSA Alliance) – MDIC
- Computer Systems Assurance – Developing a Plan to Get There – Astrix (astrixinc.com)
Also Read,
Adopting and transitioning to Computer Systems Assurance (CSA)
CSA vs. CSV – Out with the Old, In with the New.
Considerations for Making the Change to Computer Software Assurance
