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.
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
Take a preview – here’s an extract from the template pack
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.