Much has been written about validating equipment, instruments, and computer systems. Add articles written about 21 CFR Part 11 to the pile and you become engulfed in a titlewave of information. But one thing that’s often overlooked is the need to define key terms first, and then assign responsibility based upon a clear understanding of the terms you’ve just defined.
You can start out with standard definitions and then refine them to meet your own organization’s specific meaning. For example, International Society of Pharmaceutical Engineers (ISPE) has already defined the terms just mentioned:
Apparatus used to conduct the required process or test.
Device or devices used to carry out a measurement.
Computer Related System:
Computerized system plus its operating environment.
These definitions appear straightforward. However, the destinctions are not always clear. For example, equipment and instruments have computers. An instrument can be used to conduct a test. Equipment can carry out a measurement. You won’t be able to establish one definition for each term that answers every situation that can arise. You can establish a clear understanding that addresses the majority of situations that arise in your organization.
With terms clearly defined, you can determine which function will be responsible for a given item. Where it is still not clear then you can make a decision given a unique piece of equipment, instrument, or computer system, and then assign responsibility accordingly.With definitions clarified, and functions identified, you can now beging developing procedures. Here it is important to understand the intent of 21 CFR Part 11’s intention behind validation. The purpose of validation is to ensure:
- Consistent intended performance
- Ability to discern invalid or altered records
The next thing you need to determine is when something needs to be validated. Regulation stipulates that a computer system must be validated when it is used to provide information to a regulatory body, or meet requirements for a regulatory body. Clarifying this requirement will not only save a lot of time, but it will also ensure you’re compliant. Furthermore, it will help you prevent validating something that may not need to be validated in the first place; or, that may only need to be validated with a minimal level of rigor. With clarity, you can assess each individual system to determine if it’s in scope.
Don’t underestimate how challenging it can be to define and come to agreement on key terms. Ensure you assemble the right team of subject matter experts. Make sure the team is multidisciplinary. Give them adequate time to come up with agreed upon definitions. Then communicate the definitions to all so that nobody has an alternate definition.
Believe it or not, simply defining terms up-front will save a significant amount of time and help you avoid a lot of frustration.
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.|
21 CFR Part 11 Audit Trails Data Security Equipment Validation Gap Assessment GXP Validation Instrument Validation