EQUIPMENT VALIDATION IS NOT PROCESS VALIDATION

Posted on June 11, 2014

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Frequently we get calls from medical device companies telling us that they need to validate their processes, either because a customer, a partner, the FDA, or another regulatory body has cited them during an audit for lack of process validation. In many of these situations, the statement of work presented to us includes IQ, OQ, and PQ for the equipment and product, but not validation of the process. Process validation cannot proceed without calibrated and qualified/validated...

Don’t let the User Manual become the User

Posted on June 12, 2013

Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software. Sounds pretty straight forward, right? But when we look at the customer’s user requirements documents, we realized that they were derived from user manuals and specification sheets that manufacturers provide for that equipment. Some requirements even read like advertising lingo and performance claims from a website....

Keeping up with the FDA

Posted on December 11, 2012

Quite a few companies in FDA regulated industries are experiencing "Dynamic Shock." After handling their operations and quality assurance in the same manner for years, they are suddenly faced with severe findings on a 483, or are even issued a warning letter. Dynamic Shock stems from the constantly shifting nature of the industry and the practical policy changes the FDA makes, with the goal of constant industry improvement. These changes often take the form of industry guidances, which reflect the FDA's current mindset about various aspects of certain industries. Some guidances receive large amounts of attention in the media and are difficult to overlook. Others however, are less publicized and are missed by some companies, resulting in negative findings during an FDA site visit.

The FDA does make serious efforts to ensure that regulatory information is readily available to the public. Fda.gov contains a vast wealth of literature, including industry...

Validating the Cloud

Posted on November 14, 2012

As a sales guy, I am often speaking to Life Science professionals about the challenges they face. The subject that keeps coming up of late is the Cloud. There seems to be a lot of confusion, concerns and excitement about the possibilities that the Cloud presents for regulated industries. Our resident expert Leo Perskii received high praise when he presented on this very topic recently in San Diego. This 4 part series is now available and this month we are excited to share it with you.

Part 1: Leo explains the characteristics of Cloud Computing.  It’s a brief rundown of what the Cloud is and why the regulated industry should care.

Part 2: What should you consider when deciding if the Cloud is right for your company? This video is a great place to start.

Part 3: Once you have decided that the Cloud will work for you then how do you decide who to engage as your provider? There are questions you need to ask and things to consider.

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