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Featured Articles

January 2010

Automating Document Control Processes to Comply with FDA and ISO Requirements

ISO and FDA Current Good Manufacturing Practices (CGMPs) presume that both the process and documentation that directs company processes follows pre-approved methods and that any change to these methods is restricted to authorized personnel and tracked for future review. All FDA-regulated and ISO-certified companies are mandated to have a document change control system. Today's quality management systems provide integrated solutions to handle everything from corrective /preventive actions (CAPA) through change control and training. This article will focus on document control processes within the quality system lifecycle and provide insight into the capabilities needed to automate change control processes that will increase efficiency, ensure compliance with FDA requirements and improve overall profitability.

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Data and Content Migrations: Minimizing the Risk

Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understood. In this context, risks associated with data migrations are a direct result of migration error. Further, industry testing strategies to mitigate such risk, or more specifically data migration error, lack consistency and are far from deterministic. This is the first of two articles that present some thoughts and recommendations on how such a testing strategy can be designed.

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Quality Event Management CAPA Training
March 3-4, 2010, Washington DC

Quality Event Management CAPA Training
April 14-15, 2010, Boston, MA

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October 9, 2010, Baltimore, MD

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Did you know that you can stop wondering whether all of your employees have been trained on the latest SOP revisions? It's common for blood and/or biologics companies to struggle with the continuous task of training management but training and document management can be integrated and streamlined in such a way that compliant training practices become a habit instead of a chore.
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