All "Compliance" articles

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

Data integrity was a crucial trend in warning letters issued by the FDA last year, along with a significant increase in international inspections. ...

The Key to Future-Proofing Pharma Compliance

Many organizations take a reactive approach to compliance management. This means corrective action isn't taken until the organization is facing an ...

9 Ways to Ensure Medical Product Compliance Through Quality

In our work with medical device product developers and manufacturers, we know quite well the stress that comes with scrutiny of regulatory ...

5 Ways that a QMS Improves ISO 9001 Management

A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers

Too Late for a QMS: Theranos' Ignoring FDA Compliance Will Cost it Billions

Theranos, the once-hot clinical testing start-up, has taken a beating in the press recently. With almost $700 million in venture funding and ...

If it’s not documented, it didn’t happen

 

Failure to Comply - Document Control in a Regulated Industry

It is not possible to overstate the importance of effective document control in a highly regulated industry such as medical devices. Those of you ...
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