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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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Ensuring quality control and compliance

OpenText Information Management

How does an emerging pharmaceutical company manage rapid growth, protect its intellectual property (IP) and comply with strict regulatory requirements? The company is pioneering a new class of medicines to address … The post Ensuring quality control and compliance appeared first on OpenText Blogs.

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FDA Regulatory Compliance: Can You Prove What Your Website Said?

Hanzo Learning Center

If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. Will you be able to point to functional, interactive website archives to prove that your former content was, in fact, in compliance with regulations?

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The Value of Data Governance and How to Quantify It

erwin

For example, one global pharmaceutical giant reduced cost by 70 percent and generated 95 percent of production code with “zero touch.” Risk Management and Regulatory Compliance. Risk management, specifically around regulatory compliance, is an important use case to demonstrate the true value of data governance.

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New Gimmal Partnership with NNIT Brings Life Science Customers an Accelerated, GxP-Capable Information Governance Solution

Gimmal

The new collaboration is off to a great start with its first successfully completed joint solution delivery for a top, leading global pharmaceutical company. NNIT has deep life sciences expertise, specifically within the compliance and validation arena, so we know how important it is to document and keep immaculate records.

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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.