MasterControl's GxP Lifeline - April 2009 Edition

April 2009

Video:

Introducing Version 8.0

Feature Article:

Making the Transition to an E-System, Part II

For Pharmaceuticals and Biotechnology:

Value Adds to ISO 9001:2000 Compliance

For Medical Device:

Off-Label Promotion of Medical Devices



For Blood & Biologics:

AABB Annual Meeting Abstract Submission: Everything You Wanted to Know but Didn't Ask

Did You Know?

Did you know that few firms are measuring the cost of onboarding?


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Making the Transition to an E-System, Part II

Once an electronic system has gone through the validation process and is in production, users can access it to initiate, review, and approve documents in accord with the SOPs against which they have undergone training. The validation process will have set specifications for the system based on user requirements, so the system will be able to accommodate all the documents the system has been built to hold, and to identify users by passwords linked to the users' names.

The first step in creating a new document in a new system is to ascertain whether the document is actually needed. A brand new system is not searchable, so initial determination for a document needs to be based on the former system. If a document is necessary, reviewers confirm within the new system, and the author can begin to prepare a document. Typically, system administrators make templates available to authors so that they can generate a new document.


For Pharmaceuticals and Biotechnology: Value Adds to ISO 9001:2000 Compliance

The revision of ISO 9001:2000, completed in 2008, is an amendment to the current standard. The changes fail to address some of the needs of organizations wanting to extend their quality management systems toward excellence. Sandford Liebesman suggests several ways organizations can internally improve upon these requirements.


For Medical Device: Off-Label Promotion of Medical Devices

Pharmaceutical companies that promote their products for off-label use continue to be the subject of intense regulatory scrutiny. But they are no longer alone. Recent statements by government prosecutors suggest an increased focus on the sales and marketing practices of device companies. The medical device industry should expect heightened scrutiny from the "usual" actors, including the Food and Drug Administration (FDA), the Office of the Inspector General (OIG) of the Department of Health and Human Services, the Department of Justice (DOJ) and U.S. Attorneys Offices, and state Medicaid fraud control units and consumer protection bureaus.


For Blood & Biologics: AABB Annual Meeting Abstract Submission: Everything You Wanted to Know but Didn't Ask

The AABB Annual Meeting and TXPO, slated for October 24 - 27 in New Orleans, hosts many educational activities. Among these is the Abstract Poster session, an opportunity to share your research with others and possibly obtain preliminary publication for grant and funding purposes.


Did You Know?

Did you know that few firms are measuring the cost of onboarding?



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