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June 2009

QMS Pains in the Blood and Biologics World

Maintaining a quality system within a blood and biologics organization is a very resource-intensive endeavor. Changes resulting from new regulations, new and updated procedures, new techniques, changes in suppliers and supplies, new and enhanced safety practices, and the like, all result in a massive amount of change that must occur across the organization. Managing these changes in turn requires the assignment of multiple resources across multiple areas of an organization. These are just the quality process changes—There are also a multitude of documents within an organization that must be managed; everything from contracts to meeting minutes and press releases to correspondence with external regulatory agencies must be approved prior to distribution.

After changes are made to various documents in the regulated blood and biologics environment, training must also take place. Making sure all affected employees are competent in regard to document changes is a process in and of itself. Staff must be trained and the organization's management must be assured that staff members completely understand the changes prior to performing the affected tasks. If this does not occur, then precious gifts in the form of donations can be collected or recovered incorrectly, wasting the gift and ultimately driving up costs.

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AABB Annual Meeting & TXPO 2009
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GMP & FDA Compliant Quality & Doc Systems 2009
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Did you know that the FDA is pursuing a future where all regulated product information is electronic? The FDA is currently implementing numerous systems which promise to usher in a new era of electronic interactions between the agency and its constituents (i.e. industry and consumers).

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