VALIDATION PLAN
Validation Plan Scope.This Validation Plan, follows our well developed method of using a generic document and allowing the customer to apply an attached detailed SOP, to it. Turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures including the use of Validation protocols such as DQ, IQ, OQ, PQ, along with the associated VMP, URS, VRA, and VP , as used for small to medium sized projects, involving production/facility/utility equipment using electronic controls or monitors. VP PLAN SCOPE.The Validation Master Plan (VMP) is the most important documents because it describes the basis concept for your overall site validation programme. This interactive detailed document is a delight and simple to use. The generic template and attached SOP lead you through the whole process quickly and seamlessly. This thirty page document is suitable for all types of pharmaceutical /biotechnical / medical device / API, manufacturer and or processer. The VMP addresses process validation, facility validation, utility validation, equipment qualification and cleaning validation. The objective is to define responsibilities, outline your methods involved in the qualification and validation of your facility, define the areas and systems to be qualified and validated and to provide a programme for achieving and maintaining a validated status. THE VP ROLE IN THE VALIDATION PROCESS.
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SOP for Spreadsheet Creation.
Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
SOP for Spreadsheet Creation. -- $125.00
Spreadsheet Validation Package. (Issue-1) -- $525.00
SOP Equipment Validation.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
Purchase your copy now at Special Price of $22.00.
Equipment combined IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.
Validation Risk Assessment.
It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download. This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments as this is now a mandatory requirement.
Validation Risk Assessment (Issue10.) -- $125.00
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