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Posts about Life Sciences

Blog Home | Tag: Life Sciences
May 29, 2020

FDAs Computer Software Assurance (CSA) – Part 3 of 3

The efficiencies gained, according to ValGenesis customers, range from 50% to 80% improvements. This lessens demand and allows more time to be focused on higher priority tasks. Knowing the ValGenesis VLMS ensures controls and standards are followed, according to customer-specific requirements, stakeholders are given a high-degree of assurance that Quality is ingrained in the process.

December 13, 2019

Genesis of Validation: Personal, Professional And Public

Validation is personal, professional, and public! Going “paperless” is then crucial to progressing on the 2020-2030 journey. So it is clear, on reflecting on the early days of ValGenesis –why the name “ValGenesis” is so appropriate for a 100% Paperless Validation Lifecycle Management System.

April 25, 2019

FDA approves record number of drugs in 2018

As the folks at the FDA continue to improve the speed of their review/approval processes, many organizations in the life sciences and pharmaceutical industries are working hard to implement new technologies to efficiently manage their validation needs.

March 22, 2018

Are you GDPR ready?

The deadline to comply with the EU General Data Protection Regulation (GDPR) is May 25, 2018. Are you ready? For Life Science companies you may be readier than you think. The key is to leverage the controls and practices that you already should have in place.

January 17, 2018

Requirements Traceability Matrix in the Life Sciences Industry

Unfortunately, the manual process required for creating a Requirements Traceability Matrix is very time consuming, inefficient and not cost effective due to the amount of resources and time required to maintain them during the lifecycle.