Promoting a Validation Mindset: Overview


Among our cadre of validation engineers and specialists we offer an experienced and knowledgeable team of personnel whose area of expertise is focused on the delivery of validation services for computerized systems. With decades of combined experience in the computerized systems validation field, our team has gained an informed point of view of what constitutes a successful validation project and the organizational practices the make it successful. We would like to share that vision with you.

It is our intent to provide our clients with an efficient, effective, and cost-conscious solution to your validation needs. Ultimately, it is our goal to provide the peace of mind that comes from knowing that your validation investment produces an appropriately validated system that will stand up to the scrutiny of any regulatory agency inspection.

So how is a successful validation achieved? First of all, it is important to establish the right mindset among the stakeholders involved in every aspect of the validated system life-cycle from its conception, to its production environment, and its ultimate retirement. This includes everyone from the system owner to its end users.

Validation is not intended to be a painful process imposed by external regulatory agencies, but is intended to be a set of best practices that support and enhance the quality systems intrinsic to delivery of safe, effective product to the consumer market.

Consider validation to be a component of your quality system. A quality system is much like a health regimen. A healthy lifestyle includes components such as diet, exercise, and rest. Neglecting any of these components in the course of you daily life will negatively impact your well-being. These aren’t things that you tend to for the sake of your doctor, and placing your attention on these components as an after-though in anticipation of your next check-up will not produce the desired outcome. Awareness of and adherence to a lifestyle of daily practices will. It will also bring the the added health benefit of reducing stress and worry over the state of your health.

Acknowledging that the highest efficiency is to be gained by building quality into you process rather than at the end of your process, it makes sense that the validation component should be built into the full life-cycle of the system. Validation, when interposed at the end of your development process, introduces a risk to your project budget and schedule. Documentation (i.e. user requirements, functional specifications) efforts addressed retrospectively to the development process become a costly process of reverse engineering. Most often, unexpected system quality issues are discovered that require remediation. Remediation while the system is under a controlled state for qualification can be a complex and costly prospect. From a business perspective, the point of a well designed quality system is to deliver the best possible product quality while minimizing loss due to scrap and rework. It all comes down to a healthy cost-to-benefit ratio and a win-win outcome for your business and for the consumer.
To this end, Performance Validation will present an ongoing series of articles on the subject of how to approach a healthy “validation mindset” within your organization. It is our hope that these articles will give you food for thought toward developing and promoting your own set of best practices to benefit your validation efforts for the long run. Each article will focus on an specific aspect of validation; a documentation deliverable, a team stakeholder, a regulatory component, etc. Take what you will from each article. Your questions and comments are welcome.

About Performance Validation:
Performance Validation has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers. Have a question on Commissioning, Qualification, Validation please use our Contact Us form.