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Important cGMP Considerations For Implementing Electronic Batch Records While human error is never the ultimate root cause, mistakes in batch records can have considerable consequences for the release of medicines in terms of delays and rejections. In more serious cases, when the error is initially undetected, the consequence can be a product recall. Errors can be minimized through the implementation of electronic batch records. However, with any electronic system within the pharmaceutical industry, the requirements of current good manufacturing practice (cGMP), including those of data integr...

SMi Group Reports: The 4th Annual Pharmaceutical Microbiology West Coast Virtual Conference, June 17– 18 2021 with two interactive workshops on June 16th.

Press release content from PR Newswire. The AP news staff was not involved in its creation.

4 February 2021 More and more the FDA is issuing warning letters as a result of laboratories not following current Good Documentation Practices (GDP). A lack of data integrity can lead to facility shutdown, import bans, recalls, lawsuits, and a drop in brand value and market share.  In this white paper, Abbott Informatics demonstrates how you can achieve compliance with the data integrity expectations of the Food and Drug Administration (FDA) as well as other regulatory authorities by utilizing a standalone version of STARLIMS Scientific Data Management System.    Download 10,000+

This infographic, from Abbott Informatics, illustrates how you can overcome challenges and achieve compliance with the data integrity expectations of multiple regulatory authorities by utilizing the standalone STARLIMS Scientific Data Management System (SDMS).