During a validation exercise, it can be difficult to figure out at what stage the process is at. It can be quite chaotic at times with production supervisors, operators, technicians, validation personnel etc are all vying for their own place in the process. Some time ago, we decided that a useful aid in helping communication [...]
It is a common misunderstanding that validation exercises are not the concern of the on-site Qualified Person. This can often be experienced, particularly in larger companies, where the Validation department can be segregated, to some degree, from the Quality Assurance department.
It can easily happen, that once validation exercises are completed, the validation documentation can [...]
When validating computer systems and applications an array of screenshots and other such supporting documentation is frequently used. All too often, supporting information is simply stored in a database and is easily accessible, which means that the information can be extracted by use of an SQL query and presented in a user-friendly format with [...]
So you have a validation protocol to execute and you want it to run smoothly without raising too many deviations and discrepancies (if possible). What is the best approach to take and what are the main things you need to look out for.
Here are my top 10 tips:
1. Ensure that the protocol has been written [...]
This article will present a simple method for validating MS Excel spreadsheets for GXP use. The goal of our validation strategy is to provide better testing and documentation of individual spreadsheets in less time. Once we establish this methodology, we can rapidly apply it to many spreadsheets to reach compliance faster.
Scope
This article will [...]
So the Validation Department generate the protocol and the Quality Department are involved in reviewing the protocol. Having worked on various different projects it has become quite apparent that the quality review on any protocol is a very important review as it irons out all of the documentation mistakes that occur when the document is [...]
Due to the fact that so much repair work is involved the results of an internal audit are often ignored only to turn up during an external audit. If there is a huge amount of work that the internal audit shows needs to be done, then at least generate a remediation plan on how you [...]
After months of hard work, we are pleased to announce the release of askaboutvalidation.com 2.0. I would particularly like to extend my sincere thanks to all of those who participated in helping us with our new design concept, especially Richard Fang our chief designer and Robin Metcalf our chief coder on the site.
How the story [...]
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. The improved GAMP® guide offers a more flexible risk based approach to compliant [...]
Are are fed up, tired of it all. Your boss has been harassing you to develop “a scientifically sound, logical, and rational basis for cleaning acceptance limits.” Should be simple enough, right? Yet, every time you ask someone about setting cleaning limits they look at you as if you have three, maybe four heads. Asking [...]
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