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.
Complete the registration form and download the white paper in PDF format.
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.
With the FDA's heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners.
A major medical device manufacturer has recently revealed significant airborne reduction counts. The facility based in the USA achieved this result by evaluating their contamination control methods at floor level.
This report by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) highlights the critical role of the FDA in today's biomedical research and innovation ecosystem, and the need for a strong, science-based agency and an efficient, consistent and transparent regulatory process.
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.
For years, drug manufacturers have been caught between two opposing forces supply chain management and supply quality management. The only way to confront these challenges is to create a culture of quality that begins at the top and permeates down through the supply chain. This paper looks at how it can be done.
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.