No matter how hard you try, if you don’t use templates, you will likely end up giving a sloppy, inconsistent look to all the various deliverables involved with a validation activity. Many of the deliverables on a validation project are “boiler-plate” and it doesn’t make much sense to recreate the wheel each time a new project commences.
The benefits of using templates become obvious very quickly through a consistency between deliverable from one project to the next. Even when multiple people generate the deliverables, they all have the same look and feel. This consistency makes it easier for auditors to audit, and reviewers to review. It also gives them a warm fuzzy feeling to see consistent verbiage and approach between systems and departments. Using templates just looks professional and well thought out.
Another advantage of templates is that it provides a “gentle reminder” to document authors and project management, what exactly was needed for the validation effort. This prevents important deliverables like SOP’s, training documentation and Vendor Audits from becoming forgotten in the scramble of protocol development and execution.
Not Just for Protocols
You can use validation templates for everything, from SOP’s to Vendor Audits, Validation Plans, Protocols, and Final Reports to the verbiage you use when creating test scripts. The great advantage of the latter is that each tester will not be forced to come up with their own verbiage for say testing a Numeric field. Using a test script template allows multiple test-writers simultaneously to produce test scripts that are very consistent in format and technology. Essentially, the end result is a protocol that looks like it was generated by one person instead of many, which will look very professional.
If that isn’t enough reason to take the time to generate a test script template for your testers to use, then consider this: it takes a lot less time to cut-and-paste in a template, then tailor it to the field being tested, than it does for your test writers to struggle to come up with their own verbiage for every different field and field type.
Validation templates are a great way to add consistency to all your validation projects and activities, with the added advantage of reducing time spent on training. Validation templates should be generated by experienced people who understand exactly what the template needs to be used for, they should be written in a clear concise manner with no ambiguity throughout. There is little point in developing complex templates if nobody can understand how to use them.
Each template should be reviewed by the relevant stakeholders before approval takes place. What may make sense to a validation engineer may not make sense to the quality person reviewing the document.
Tamara Follett has an M.S. in Computer Science and over 20 years experience in all aspects of cGxP Computer Validation. As an Independent Consultant serving the Pharmaceutical, Clinical Trials and Medical Device Industries, she developed and executed many large-scale computer validations and re-validations, identifying such critical deviations as data loss and data corruption prior to the system going into production.
She has generated and maintained Master Plans, Validation Plans/IQ/OQ/PQ/Final Reports/Deviation Logs/Deliverable Lists, and other project documentation such as procedures, work instructions and guidelines. She has developed comprehensive Life Cycle Documentation for numerous legacy and new systems, including Requirements, Specifications, Traceability Matrices, SOPs, Training/User Guides, and other SDLC deliverables, including: Needs Analysis, Vendor Gap Analysis, Risk Assessments, Disaster Recovery Plans, etc.
Ms. Follett has conducted numerous Compliance Audits, Quality Audits and 21 CFR Part 11 Audits. Considered to be a Subject Matter Expert in Computer Validation by Stat-A-Matrix, CSSC, and other validation industry leaders, she is a sought-after speaker and auditor.