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The Gage R&R is used to verify results which cannot be validated, very often this is for operator led activity which may produce attribute or variable results.
A 3-page preview of the Gage R&R Template is available here:
You may purchase the full 9 page document in convenient Microsoft Word format including instructions for use below.
To comply with 21 CFR part 11 Electronic Records & Signatures, you will need to ensure that your records and data which holds any quality critical information will require validation and verified.
A preview of the the IOPQ Validation Protocol is available here:
You may purchase the full 10 page document in convenient Microsoft Word format including instructions for use below.
If you have installed equipment that has successfully established its limits and there is no need to test these then you can progress to PQ, upon which the template will guide you demonstrate consistency by running three batches. You will need to run your PQ in a normal environment.
A 3-page preview of the Performance Qualification Validation Protocol is available here:
You may purchase the full 12 page document in convenient Microsoft Word format for use below.
As part of your manufacturing procedure you must have Standard Operating Procedures to ensure that all stages of the process of manufacture is standardised under a controlled document that is easy to follow which can be assisted with aid of visual diagrams or photos.
A 2-page preview of the SOP Template is available here:
The URS (User Requirements Specification) is a document that indicates what your requirements are so that the supplier is clear from the outset as to your specifications of purchase.
A 4-page preview of the User Requirement Specification Validation Protocol is available here:
You may purchase the full 12 page document in convenient Microsoft Word format for use below.
Your site wide document and take on validations should be clearly outlined in a high level document which is your Validation Master Plan or Policy which indicates your approach to validation from software systems to lab, cleaning, equipment etc.
A 7-page preview of the Validation Policy Template is available here:
You may purchase the full 16 page document in convenient Microsoft Word format including instructions for use below.
For each validation you will need to document how you plan to approach your validation, the strategy and the rationale behind your decision for the approach. There must be clear and well documented evidence for this.
A 3-page preview of the Validation Plan Template is available here:
You may purchase the full 10 page document in convenient Microsoft Word format including instructions for use below.
The Validation Toolkit is the answer to those who are either new to Validation, or those who want a simplified start to a validation approach. Pharmi Med Validations have used all their experience to piece together the essential components of a successful Validation system for both Medical Device and the Pharmaceutical industries; this toolkit will work.
A 16-page preview of the Validation Toolkit is available here: