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 a software validation requirement.
The document that specifies software validation standards for your computer requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. This document was designed to be used as a live document up until the DQ is completed and approved.
The Computer Validation Master Plan, is the starting point for software validation, and hence the most important validation online document. It greatly improves validation efficiency by forcing all concerned to document, review, and discuss, the proposed methods and allotted responsibilities. It is an expected document with the FDA, and a mandated document with the EU.
This document follows Validation Online's standard method of using a fully detailed and interactive generic document and enabling to use the attached SOP to quickly convert this generic document into a first class company bespoke document. This Computer System Validation Template, details and integrates all computer validation online activities and procedures required for a small to medium sized project, involving production / facility / utility equipment using electronic controls or monitoring.
This software validation package is suitable for all major computer validation projects and contains the underlisted interactive documents. VMP, VP, URS, VRA, DQ, IQ, OQ and PQ.
Package Computer Validation Level-2. (Issue 3) - $ 610.00
The complete chain of regulatory required documentation for the software validation template of a computer system; minus the VMP. This computer Validation Package contains one of each of these documents: VP, URS, DQ, VRA, IQ, OQ, PQ.
This software validation vendor Audit document should be customized using the built in tools. The document can then be targeted to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. This enables your assessment to be expressed simple and clearly as a percentage, allowing clear unambiguous comparisons to be presented for competing companies.
Computer Installation Qualification (CIQ) is an important step in the overall software validation and qualification process for software and computer validation systems. Our protocol leads you through the detailed requirements.
Operational Qualification (OQ) is an important step in the overall software validation and qualification process for software and computer systems. Our protocol leads you through the detailed requirements, progressively and simply.
The Computer Performance Qualification is the culmination of the computer validation process. The protocol is used in conjunction with the system operating SOP, to verify that the system process is consistent and correct. The results of the testing must be recorder and reviewed with a view to ensuring that any deviations (within permitted tolerances) that exist are random and not a trend that will lead to out of specification operation during production use.