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DID YOU KNOW...

That, according to the Pharmaceutical Research and Manufacturers of America (PHRMA), only one out of every 10,000 potential medicines investigated by research-based pharmaceutical companies makes it through the research/ development pipeline and is approved for patient use by the FDA?
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Especially for Pharmaceuticals

Find out how a three-stage maturity model can help your biotech company effectively assess and manage IT costs.
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Especially for Pharmaceuticals


Especially for Medical Devices

Medical device companies face significant project management difficulties when developing new products. Here are three of the most common project management challenges and potential solutions to each.
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Especially for Medical Devices



Especially for Blood / Biologics

Training entry level employees to become competent in a laboratory or technical environment is expensive and time-consuming. Is there a way to assess how much they learned during training?
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Especially for Blood / Biologics



Six Ways to Optimize Your Quality Management System to Ensure FDA and ISO Compliance

An optimal quality management system is the foundation for long-term regulatory compliance and enduring market success. The following suggestions can help optimize your quality management system to ensure high-quality products/services and continuous compliance.

(1) Automate Your System
Many companies in the FDA and ISO sectors continue to rely on paper-based or hybrid (partially electronic) quality management systems. Unfortunately, such systems are inherently inefficient and error prone. They lack a secure, centralized document repository for organizing documents, and, as a result, they also lack instant access to the most up-to-date product design and quality information. In contrast, a fully automated system that provides a secure, centralized document repository facilitates access to the most current version of all documents. This is a minimum requirement of an efficient system. It sets the stage for the implementation of automated, connected processes and workflows, which greatly enhance a manufacturer?s ability to implement a quality management system for providing continuous regulatory compliance.

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New Document Scanning Interface Directly Uploads Scanned Documentation into Document Management System

Tired of typing electronic versions of paper documentation such as audit records, clinical documentation or shipping and receiving documents for storage in your document control system? Sick of recreating legacy documents like lab notebooks quotes, applications, and resumes? These are problems of the past, thanks to a new release script from MasterControl Inc. and Kofax.

MasterControl and Kofax have developed an interface that integrates Kofax scanning technology with MasterControl?s electronic document control system. The custom release script software now available from MasterControl makes it possible to use Kofax?s Optical Character Recognition (OCR) tools to digitally capture existing documentation and directly upload and automatically store the scanned documents in a MasterControl system.

According to Warren English, IT director with Salix Pharmaceuticals, Inc., the scanning interface can be useful for converting documentation such as invoices, clinical documents and case report forms. English says the new document scanning software interface makes it possible for a company to consolidate its protocols for converting electronic documents. ?Right now, some of our departments are doing that (scanning) on their own,? says English. ?We?ve been looking at getting something set up to do it centrally. That makes (document scanning software) a useful thing for us.? English also brings up the point that the interface will allow companies currently outsourcing large amounts of documentation to contractors to save time and money by scanning in-house.

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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

Biowest 2007
(Dec. 6-7, 2007)

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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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Editorial Staff

We Want Your Feature Articles


GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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GxP Lifeline
is published once a month by MasterControl Inc.
6322 S. 3000 E., Suite 110
Salt Lake City, UT 84121
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Web site: www.mastercontrol.com

Publisher: Curt Porritt
Executive Editor: Jason Clegg
Design: Mike Hansen
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