Built in Microsoft® Word for easy editing, the Validation Template pack includes the templates for developing Validation Plans, Specifications, Protocols and Reports in accordance with FDA and PIC/S requirements for qualification and validation.
The templates are used by our consultants in the field and are full of practical guidance and how-to instructions. They are easy to use and will save you weeks, if not months, of time.
Ideal for startup pharmaceutical or life science companies who must comply with PIC/S (TGA) or FDA GMP guidelines.
Please note: You may use each individual Product, modified or unmodified, at a single company only, belonging to either you or your client. You must purchase the same Product again in order to use it at another company or for another client.
Validation Templates / Protocols
What’s included in this pack of validation templates?
The pack includes the templates for developing Validation Plans, Specifications, Protocols and Reports in accordance with FDA and PIC/S requirements for qualification and validation and most importantly, adopts the latest thinking on a risk-based approach to validation, as prescribed Annex 15.
The following templates are included:
Validation Exception Report Template
Installation Qualification Template
Operational Qualification Template
Performance Qualification Template
Process Validation Protocol Template
Cleaning Validation Protocol Template
Validation Procedure Template
Criticality & Risk Assessment for Validation Procedure Template
User Requirement Specification Template
Validation Master Plan Template
Validation Plan Equipment Qualification Template
Validation Plan Process Validation Template
Validation Project Plan Template
Validation Summary Report Template
Validation Register Template
Requirements Traceability Matrix Template
Get help from our regulatory compliance experts
Included in the price is two hours of support via telephone or email. Feel confident in the knowledge that if you have questions or get stuck then you can speak to a GMP compliance specialist to set you on the right path.
Our consultants have many years of experience working in the pharma and medical device industries. You can benefit from their knowledge of what works and what doesn’t when creating and maintaining a pharmaceutical quality management system.