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Why IDMP compliance requires adaptive data governance

Collibra

Pharmaceutical, biotech and medical devices firms, among others, must comply with a plethora of regulations. This requires every company to perform gap analysis to determine what is required and then update their systems, processes, workflows and data management strategy accordingly to ensure compliance.

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How a global research and manufacturing company achieves regulatory compliance

OpenText Information Management

As a Contract Research and Manufacturing organization with over 330 clients around the globe, regulatory compliance is non-negotiable for Syngene International. Its integrated scientific solutions necessitate careful documenting of trials, test results, product formulae, manufacturing processes, and more.

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Assembling the pieces: Archiving and retention in Life Sciences

OpenText Information Management

In the world of pharmaceuticals, something interesting keeps happening — companies acquire, merge, or divest from other companies. It’s like a puzzle they’re trying to solve getting the right products, improving their research options or manufacturing capacity, and making sure everyone knows they’re here to stay.

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Regulatory Information Management Systems: The What & the Why

Gimmal

Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review.

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Learn. Transform. Advance.

erwin

To survive and eventually thrive in the face of radical disruption requires transformation that’s just as radical: Developing new business models, like breweries and distillers manufacturing hand sanitizer. Confront new compliance challenges as a result of the changes you had to institute? Have you had to revisit and reset priorities?

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Q&A: How AI, digital transformation are shaking up revenue management in high tech, life sciences

The Last Watchdog

based life sciences and high-tech manufacturing companies sheds light on how digital transformation – and the rising role of third-party partners – have combined to create unprecedented operational challenges in the brave new world of digital commerce. A recent poll of some 300 senior executives from U.S.-based LW: How does AI factor in?

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Enterprise Architecture: Secrets to Success

erwin

Today, enterprises are trying to grow and innovate – while cutting costs and managing compliance – in the midst of a global pandemic. Compliance and Legislation : How do we manage uncertainty around legislative change (e.g., Enterprise architecture is central to managing change and addressing key issues facing organizations.