A Different Way of Thinking to Improve Validation!
Traditionally, Validation focuses validating something (i.e., an Entity), such as equipment, a computer system, a process, etc. A lot of paper is generated (e.g., VP, IQ, OQ, PQ, RTM). Then the validation package is filed away, typically only pulled during an audit.
The problem is that the same things are continually recreated. Inconsistencies arise, and valuable information is lost in the paper pile. However, if you objectify your validation you can reuse elements; this delivers consistency and maximizes efficiency.
How do you objectify validation? First, change the way you think. Rather than validating a thing, think of the logical groups of things you validate. For example, consider an autoclave. How similar are validation packages for your autoclaves? No doubt very similar. In fact, if there are differences ask yourself, Why? Maybe there a good reason, or maybe not. Most likely requirements are similar. Also, similarities with risk assessments probably exist. Risk drives rigor; therefore, qualification tests are probably similar. Why not create objects of similar things that can be reused? Now you’re getting the concept of Objectification.
Technology to the Rescue
Traditional paper-based validation is limited. Although you can standardize on requirements, risk assessments, and qualification scripts for like entities, it doesn’t deliver maximum benefit for paper-based validations.
The ValGenesis Validation Lifecycle Management System (VLMS) has capitalized on delivering functionality to support object oriented validation. Here you can create requirements as objects, and these can be shared. Furthermore, you can perform risk assessments on the requirements, thus driving the rigor of qualification testing. Next, you can then develop similar qualification tests. In effect, you’re building a library of objects that can be assembled to form a validation package.
Libraries of Objects Drive Consistency & Efficiency
In the example above we only discussed autoclaves; but objects can be created for logical groupings of entities. Validating computer systems have similarities. Take for example 21 CFR Part 11 (Part 11) requirements. They’re the same. Why not develop Part 11 requirements that can be used for all computer system validation activities?
If you create objects, you can then create a library of objects that can be pulled to develop validation deliverables (requirements, test scripts, etc.). In the VLMS mentioned above, this is done through Test Functions. You can develop Test Functions for equipment, computer systems, instruments, processes, etc.
When it comes to initiating validation, you simply compile all the objects together and voilà, you’ve just assembled 50% to 80% of your validation package, depending upon how many objects you’ve developed.
A rudimentary form of objectifying validation is being done when you copy and edit documents from prior validation packages. By leveraging technology, you can formalize this practice by creating objects that can be assembled together to comprise a validation package.
For more information please contact ValGenesis to schedule a demonstration to see how this is not only possible, but how some are already taking advantage of an object-oriented validation practice.
About the Author
|Steve Thompson is Senior Manager of Professional Services and is responsible for managing ValGenesis’s Implementation & Professional Services in the West Coast Region of the United States. Steve has over 20 years of GxP experience in Life Sciences (including Medical Device), is a Parenteral Drug Association (PDA) certified Auditor, has held managerial positions at various levels within Information Technology (IT) and Quality Assurance (QA) for major organizations, is a published author and has presented at several conferences and industry associations. Steve has a B.S. in Computer Information Systems from DeVry University, City of Industry, California.|