Kits, Templates and much much more...
The Ulimate Server Qualification Template
Graham O'Keeffe - Premier Validation
So you’ve just finished validating your software application and your ready to go live, then some guy in the validation department asks (or worse a FDA Auditor) “Have you qualified the server the application resides on?” After all the work that’s involved in validating the application you now have to worry about the server.
So who is responsibility for qualifying the server? In my view what usually happens is that the validation department generates the validation protocol, with input from the IT department.
Once approved by the stakeholders the approved protocol is then handed over to the IT department for execution.
Fail to prepare, prepare to fail – Top Tips for Protocol Execution
Fail to prepare, prepare to fail – Top Tips for Protocol Execution
The AskaboutValidation Team
What should a test protocol contain? What is the typical content of a test protocol? Before any test execution takes place there are a number of checks you must do before entering into the world of test execution. “Fail to prepare, prepare to fail” no truer words can be spoken in relation to protocol execution. How many times have you seen executed protocols with deviation after deviation or observation after observation?
Can this be prevented or do you have to have executed protocols with mark ups everywhere on the document. Its one thing to have a clean protocol with no deviations or mark ups (rarely happens and would raise suspicion with the FDA) but its quite the opposite to have a protocol littered with mark ups everywhere to the point where someone has to ask the question "Has this been given a dry run".

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Qualification of water Systems
Water is one of the most widely used substances, and raw materials, or an ingredient in the production, processing, and formulation of pharmaceuticals. Control of the organic and inorganic impurities and microbiological quality of water is important because proliferation of micro-organisms ubiquitous in water may occur during the purification, storage, and distribution of this substance.
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Packaging Sealing Validation - A Simple Example
Once upon a time, a company decided to improve their packaging sealing process. They selected equipment with a new technology that would process more product in less time with improved seal characteristics.
Qualification of Water Systems
Water is one of the most widely used substances, and raw materials, or an ingredient in the production, processing, and formulation of pharmaceuticals.
General Test Script Instructions (CSV)
So the time has come to execute your test protocols, you’ve spent days tweaking and refining your test cases to ensure that they work first time round and you’ll end up with as few deviations and discrepancies as humanly possible.
Cleaning Validation: Types of Contamination
It is beneficial to begin the subject of cleaning with a description of how products become contaminated and a brief description of some contaminants.
Validation of MS Access Databases
This article will present a simple method for validating MS Access databases for GXP use.
How to Create a Bullet-Proof URS
Over the last number of months it has become quite apparent to us at Askaboutvalidation.com that many of you out there are finding it difficult to create URS documents (for the beginners out there User Requirement Specification’s).
EN285, HTM2010, 2031 guidelines state - Steam quality, purity and quantity can be affected by the design, use, and maintenance of the overall steam system.
What document do you consider the most difficult?
Validation documentation the good the bad and the ugly, in the world of validation there is so much documentation surrounding us each day.
GAMP 5 - Innovation in a Flexible Manner
The new GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems provides a practical approach to achieving systems that are fit for their intended use in an efficient and highly effective manner, while also enabling advancement in technology and innovation.
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Cogent Validation Services Ltd
Our business model provides the flexibility required to enable us to assist clients with their project objectives. This may be operating directly to the client to provide cost-effective solutions for small capitalisation projects
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