Validation is a key process for effective Quality Assurance (QA). However, it is often not given the time, money, and resources it deserves. This is a risk which can make or break the reputation of any organization, but especially those in heavily regulated industries where validation is a non-negotiable practice.
Validation Needs to Run the Show
Validation is a continual, consistent process of checks and balances designed to ensure that a system operates as intended. Ultimately, it is employed to ensure that organizations are proactive, not reactive. When a Master Validation Plan (MVP) is treated as an afterthought and is not initiated at the start of a process, it can leave organizations vulnerable to potential issues that may slip by unnoticed.
To prevent this, the scope of testing should be documented and approved in a Master Validation Plan during the early phase of development. This will ensure that any issues are addressed early on, instilling reassurance and confidence in an organization to move forward. Allocating the proper resources and securing accurate timelines for validation will greatly increase the chances of an effective and functioning system.
The Benefits of Validation in Regulated Industries
Appropriate and timely validation increases the probability that products will be safe, effective, and appropriate for their intended use. Validations accomplish many objectives, including determining worst case scenarios and risks during manufacturing, investigating deviations during the manufacturing process, minimizing the risk of regulatory non-compliance, and decreasing the chance that a product will fail.
Regulatory Nightmares of Poorly Planned Validations
The economic impact of regulatory fines is costly. In 2009, a well-respected pharma giant paid a $2.3 billion settlement, including a record-breaking $1.3 billion criminal fine. In 2012, another pharmaceutical company was fined $3 billion for its violations.
But as debilitating as fines can be for an organization, they are still not the worst consequence of regulatory non-compliance due to sub-standard validation; the worst-case scenario is loss of consumer life. In the instantaneous, 24/7 world we live in, catastrophes move at the speed of the Internet, and the negative consequences of diminished consumer confidence can linger long after regulatory fines have been paid.
Best advice? Validate:
- Early (Validations should be planned in your initial steps)
- Carefully (Use data that correlates to the real world, not just sample data)
- Often (Be proactive, you can’t be too careful)