How to Avoid the Top 5 LIMS Nightmares
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent. If you find yourself waking in a cold sweat worrying about common LIMS nightmares, rest assured there are technology answers to these bad dreams.
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New USP Sterile Water Testing Requirements
On April 1, 2012, the United States Pharmacopiea (USP) published the removal of the legacy Oxidizable Substance test for the water monographs Sterile Water for Injection (WFI), Sterile Purified Water (PW), Sterile Water for Inhalation, and Sterile Water for Irrigation. The proposed revisions to these monographs describe new test requirements for Total Organic Carbon Chapter and will directly affect the validation and intended use of new or existing TOC analyzers used for laboratory analysis. The deadline to comply with these new requirements is August 31, 2013.
How to Respond to (and Avoid) FDA 483s
This article shows excerpts from recent 483s issued for deviations tracking in tracking and recording environmental parameters in various applications and facilities. The article outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.
FDA Transparency Initiative: Opening FDA's 'Black Box'
Transparency promotes accountability, enhances the work of the agency, and increases its credibility with the public. This article by FDA's Special Assistant to the Principal Deputy Commissioner, Afia K. Asamoah, and published by FDLI outlines opening the proverbial 'black box' to help FDA more effectively implement its mission to promote and protect the public health.
Afia K. Asamoah, published by FDLI
Enhancing Collaboration with the FDA Through MedWatch Plus
This white paper will provide an overview of the benefits and best practices of using the FDA's MedWatch Plus initiative for electronic adverse event reporting within the pharmaceutical industry, as well as other FDA-regulated organizations.
Accounting for Risk in Your Asset Management Strategy
A risk-based asset management system will help you appropriately prioritize how you spend time, money and materials fixing the most critical problems, provide the infrastructure for continuous improvement and help you meet your corporate business objectives, including regulatory compliance. This paper offers an overview of the three key elements of an asset management strategy and presents the six steps to building a robust, risk-based asset management program.