That you can use business rules to effectively monitor and manage critical quality events? Full Story

Especially for Pharmaceuticals

How much is drug safety worth? Priceless. But for the pharmaceutical industry, the price tag is about $392.8 million in annual user fees.
By Lane Hirning
Full Story

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Especially for Pharmaceuticals

Especially for Medical Devices

The news that a company the size of GE OEC Medical Systems has a broken CAPA system is shocking. But it is not altogether unexpected if you consider inspection trends. Full Story

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Especially for Medical Devices

Especially for Blood / Biologics

For those who just survived an FDA inspection, or those preparing for one, the question is: What happens after inspection? Full Story

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Especially for Blood / Biologics

How to Solve the Top Five Change Control Challenges

If the ancient Greek philosopher Heraclitus were alive, he would probably be pleased to know that today there is such a thing as “change control.” Heraclitus once said: “Nothing endures but change.” He was right. And for life science companies, change must be managed not only because it’s inevitable but also because uncontrolled change could affect product safety and quality.

Under the FDA’s GxP requirements, a change control system is necessary to prevent inappropriate modifications. While this sounds simple, implementation can be difficult. Here are five common change management issues that companies often complain about and some tips on solving them.

1. Inefficient System of Communication. You need effective communication to be able to implement change properly. For a company that relies on a paper-based or partially electronic system, this is the typical scenario: Once or twice a week, up to 15 people who constitute the Change Control Board meet for two hours each time to discuss engineering and other document changes. Before and after each meeting, documents are routed using the inter-office mail system or via e-mail. The problem with this scenario is that everything depends on the availability and the willingness of the members to meet.
Read more.

The Big Leap into Automation: Do’s and Don’ts in System Evaluation

By Jim Murrin

The FDA is decidedly moving toward an electronic environment. Late last year, the agency solicited comments on its continuing effort to transform all regulatory submissions from paper to electronic and its plan to create an electronic platform that would facilitate the exchange of drug safety and other important clinical research information.

If you work in the life science industry, there is probably no way to avoid automation in the long run. Not only is FDA policy pointing toward that direction, the cutthroat global competition is also likely to necessitate automation. Now more than ever, companies need to innovate, accelerate product development, and reduce costs. In all three aspects, automation offers advantages far beyond what a paper system (or a partially electronic system, for that matter) could offer.

Let’s say that your organization has contemplated all this, and finally decided to take the big leap into automation. If you’re part of the selection committee, how do you go about evaluating different systems? Read more.

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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