Validation is a concept that has been evolving continuously since its first formal appearance in United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities which should take place at the conclusion of product development and at the beginning of commercial production. Validation is confirmation [...]
So your company has purchased a laser welder for production and you have been chosen to validate it. Where do you begin and what do you include? Below is a simple example for a seam or butt weld application.
Installation Qualification
The IQ must challenge the operation of the equipment to ensure it works as the manufacturer [...]
Gregor Library Inc. launched its Gregor Library today, the premier online research tool for industry professionals impacted by FDA oversight. The library contains an extensive collection of authentic FDA documents, which have been previously inaccessible to the public without a formal FOIA (Freedom of Information Act) request. Our document collection is easily searchable and accessible [...]
The purpose of warehouse mapping studies is to analyse temperature and humidity distribution, to evaluate storage conditions and identify critical zones inside the warehouse. This article intends to be a quick guide for warehouse mapping studies.
Overall Approach
Even with controlled environment inside the warehouse, the exterior weather conditions may influence the overall storage temperature and relative [...]
A lot of companies don’t like to validate spreadsheets, some say it can’t be done. Is this just a myth?
If you’ve got some data to compare or look for missing entries why do it manually? Because a human is more efficient than a computer? Right? Wrong, checking lists is boring – no one wants [...]
Software patches are issued periodically by virtually every (major) software producer on the planet. From Microsoft to Apple; Adobe to Corel. Patching is required to fix faults, increase functionality and generally just iron out faults or correct things that could be better, nevermind security!
Security
Security is the most critical area of computing nowadays and being secure [...]
Good Documentation Practices (GDP) simplified – seriously. You’ll will be amazed and relieved to know there really is an easy way to learn about Good Documentation Practices or brush up on your previous knowledge.
Step by step guide
This step-by-step guide is perfect if you’re either new to regulated environments, or just want an easy to understand [...]
How many of you grimace when you see the appointment in your diary for a risk analysis review meeting? Have we forgotten how useful this should really be? Are we also afraid to take risks? Without some risk, we cant push the boundaries out.
Why has this happened and more importantly, what can we do about [...]
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 [...]
So you just bought a new stability chamber for your facilities. Usually you can buy also the initial qualification from the vendor, or choose to do it internally by your validation team.
The purpose of this article is to describe a simple approach for stability chambers qualification.
Overall Approach
The basics of all qualifications are [...]
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