Blue Mountain Quality Resources, Inc. is set to host a discussion on the FDA’s draft guidance, recent Warning Letter findings regarding Data Integrity and how Life Science manufacturing companies can achieve data integrity in a GMP cloud environment.
“In 2017, about 20% of the Warning Letters given to Life Science and Medical Device companies involve a data integrity violation. With a soaring number of Warning Letters for data integrity violations, the FDA is on a mission to ensure that companies have reliable and accurate data. In our webinar, I will discuss the FDA's draft guidance on data integrity and how to use the cloud to achieve a compliant state in your organization,” said Ginny Lee, Quality Assurance and Business Analyst Manager at Blue Mountain Quality Resources. Lee will be leading the live webinar discussion.
Blue Mountain Quality Resources is the leading developer of industry standard asset management products and services—designed exclusively for the Life Sciences industry since 1989. The company’s Blue Mountain Regulatory Asset Manager® was the first regulatory asset management system, designed specifically as a harmonization of calibration, maintenance and validations systems into a single comprehensive solution for Life Sciences companies.
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