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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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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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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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12 considerations when choosing MES software

IBM Big Data Hub

Manufacturing execution systems (MES) have grown in popularity across the manufacturing industry. If your manufacturing processes have become more intricate and challenging to manage manually, an MES can help streamline manufacturing operations management, increase efficiency and reduce errors.

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FAIR Data Principles in Life Sciences: A case for Data Intelligence Cloud

Collibra

By adopting FAIR Data Principles, life sciences firms (pharmaceuticals, biotech, medical device manufacturers) can accelerate data sharing, improve data literacy (understanding of data) and increase overall transparency and auditability when working with data. Reusable – metadata should include rich business and technical context.

Cloud 97
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Counting Down to the EU NIS2 Directive

Thales Cloud Protection & Licensing

Counting Down to the EU NIS2 Directive madhav Thu, 05/23/2024 - 05:16 Our recently released 2024 Data Threat Report showed a direct correlation between compliance and cyber security outcomes. 84% of organizations that failed a compliance audit reported having a data breach in their history.