Regulatory Changes on the Horizon: Global Impact of the IDMP

Pharmaceutical manufacturers and CROs face increasingly complex regulatory mandates on the horizon. As requirements increase, so do opportunities for problems with lack of compliance and inconsistent data. To this end, the European Union (EU) is adopting a standard protocol for Identification of Medicinal Products (IDMP) developed by the International Organization for Standardization (ISO). The Move […]

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By the Book: Documentation Requirements in TrackWise

For pharma, CROs, and other the life sciences; even the most useful quality-management tools—such as TrackWise—aren’t without caution and concern. Large system and process-level configurations require large documentation—and it’s important to keep it all in order. Currently in widespread use, TrackWise is a robust system that’s proven flexible enough for different processes through standard configurations. […]

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All Together Now: The Benefits of Playing in a TrackWise Sandbox

In life sciences, TrackWise (Sparta Systems) is a powerful quality management tool. Even so, my colleagues and I at Glemser always look to improve on already strong foundations. We know how important a clean and organized environment is. Unfortunately, numerous groups updating or changing one environment for their own configurations can turn a clean environment […]

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