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SOLABS
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Automating quality operations isn’t typically seen as being sexy, I know. But if automating your quality operations saves you time on essential tasks, thus saving you money, and saving money is sexy, then isn’t automating quality operations, in turn, also sexy?
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Out of the box software is generally less costly and incorporates common industry best practices. A full validation package is available so that additional validation by the customer may not be required. Compliance with 21CFR Part 11 and alignment with CGMP’s is assured. The implementation timeline is shorter and the return on investment (ROI) is quicker as a result.
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We're lucky enough to have Brian Graeff (former VP of Quality Operations at Sunovion Pharmaceuticals Inc.) and John Carkner (former President and CEO at Pillar5 Pharma Inc.) on our team at SOLABS. Here are Brian and John's Top 10 Quality & Best Practices articles from the last 12 months:
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'Lean Manufacturing and Quality' by SOLABS Senior Consultant and former Pillar5Pharma CEO, John Carkner
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"While there are often formal notification requirements for quality issues, there are also sound business reasons for informing the leadership of an organization when issues arise that may have serious consequences."
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"The absence of documentation diminishes the value of the product by creating risk – risk that the product may not perform as expected. If documentation and data integrity are absent, it is not unlike a forgery in the art world- value is diminished because the reliability of the source is suspect." -John Carkner, Sr. Consultant, SOLABS Quality Assurance & Best Practices Unit
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