Tag Archives: audits

The Value of an Enterprise Quality Management System in Pre-Clinical and Clinical Development

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

Changing Regulatory Requirements – Part 1 – European Union

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

Using Vendor Documentation to Support System Validation – How It Can Help and What to Watch Out For

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

Building Billion Dollar Brands: Part 2 – Three Steps for Successfully Deploying Quality Management Software in the CPG Industry

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

Needed: Responsible Executives in Life Science Companies

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

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Mike Cudemo runs the Customer Success Program at Sparta Systems. The program accelerates knowledge transfer of best practices to our customers to enhance overall business performance. VIEW ALL PROFILES

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