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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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Fraud Detection: Lessons From Novartis Case

Data Breach Today

Compliance Expert Thomas Fox on the Role Data Analytics Can Play Incidents of fraud at pharmaceutical giant Novartis that resulted in over $1 billion in fines worldwide might have been avoided if the company's compliance team used data analytics to detect patterns, says Thomas Fox, a compliance evangelist and author.

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Using a 'Privacy by Design' Approach to GDPR Compliance

Data Breach Today

To prepare for compliance with the EU's GDPR, which will be enforced beginning in May, organizations must adopt a "privacy by design" approach, says Subhajit Deb, CISO at Dr. Reddy's Laboratories, an India headquartered pharmaceutical company that does business in 11 countries.

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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? Here’s what you’re up against.

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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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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.