The FDA issues updated Data Integrity Guidelines

With continued data integrity issues occurring during cGMP inspections, the FDA recently issued a new draft guidance to help the Pharmaceutical industry.

The guidance includes 18 questions and answers on data integrity, alongside well-defined terms on data as they relate to current good manufacturing practice (cGMP) records. It also includes recommendations on when workflows on computer systems need to be validated, and how to ensure electronic master production and control records are monitored, and can only be used by authorized personnel.


Do I Need A LIMS By 2017 - It Depends

Strategic decision-makers, QA and QC Laboratory Management, and IT professionals often ask whether they need a LIMS by 2017. Compliance with regulations is key to the decision along with managing customer expectations. Scott Schaefer writes in the Harvard Business Review that making good business decisions rests on assessing how the potential benefits and costs of a particular strategy pertains in each situation.