Tag Archives: audits

After working with hundreds of pharmaceutical companies for years, I have noticed that while there is a single company name on the building, there are dividing walls within.  These walls tend to be built between the groups that follow different … Read full article

EU 2011/62 Falsified Medicinal Products Directive and Product Quality For the pharmaceutical industry, regulations always seem to be a moving target.  As the industry changes and market challenges occur, legislators demand accountability and pass laws for regulators to enforce.  Over … Read full article

Risk-based validation means taking the right steps to manage the risk of using certain materials from a software vendor and having confidence in the system the vendor has provided.  Most system vendors have developed documentation to accelerate the validation efforts … Read full article

In our last blog post we took a deep dive look at the CPG industry. We answered the questions of what is driving change in the industry, and how companies are reducing risk, improving quality, and becoming more efficient to … Read full article

The Wall Street Journal ran an article on Tuesday, September 13 about holding officers from Life Science companies personally and criminally responsible for violations of US food and drug laws.  This should strike fear in the corporate boardroom. Congress authorized … Read full article