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Compliance & Regulatory

Continuous Delivery pipeline with CloudBees CD for major insurance carrier

The ClientFounded in the early 1900’s, this major insurance provider administers health benefits to more than 4 million individuals. Because of the types of services this client provides to its customers, they are heavily reliant upon software technology and technical...

The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction

BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...
How PLM Enables Innovation Without Risking Compliance

How PLM Enables Innovation Without Risking Compliance

As technology has advanced, it's become more complex -- and with complexity comes the issue of tracking and monitoring the different processes and their corresponding data. In non-critical applications, the extent of this reporting is often minimal. However, in...

CAPA:  A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.   One of the problem areas most often cited in company audits continue to be the CAPA system/program.   This month we will take a look at some of the latest FDA...