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Resources to Help Accelerate Your Product Development

Explore our content!  Our goal is to help you learn, implement and succeed.  See our blog, white papers, webinars, and other content.  All content is freely downloadable.

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Using Rational Response Files to Install ClearCase and ClearQuest

Using Rational Response Files to Install ClearCase and ClearQuest

This week we continue on the topic of installing using IBM Installation Manager.  But with a bit of a difference.  Instead of bringing up the IM install GUI and using it to conduct the installation, we will take a step toward greater installation automation and create...

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...

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