Jun 07, 2019  |  Posted by: 

Nathan Brown
Nathan Brown Tech Writer/Copywriter
We are currently living in an increasingly paperless wo...  
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May 09, 2019  |  Posted by: 

Nathan Brown
Nathan Brown Tech Writer/Copywriter
Hello and welcome to the first installment of our new b...  
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Apr 25, 2019  |  Posted by: 

Nathan Brown
Nathan Brown Tech Writer/Copywriter
In January 2019, the Food & Drug Administration (FD...  
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Jun 20, 2018  |  Posted by: 

Functionality that fosters GDPR Compliance

In the March 22 we wrote about Are You GDPR Ready? and highlighted ValGenesis functionality to help organizations comply with GDPR, which included:
  • Complete Lifecycle management
  • Decision Trees to determine consistent, compliant outcomes
  • Inventory of systems, including their validated sta...  
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Mar 22, 2018  |  Posted by: 

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.

What is GDPR?

In December 2015 the EU parliament voted to finalize GDPR and set May 25, 2018 as the deadline for compliance. The primary objective of GDPR is to give citizens control...  
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Feb 05, 2018  |  Posted by: 

Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information data and records generated during validation and the lifecycle of GMP systems is subject to data integrity regulatory requirements. Data integrity refers to the accuracy and consistency of stored data, indicated by an absence of any alteration in data between two updates of a data record. Data integrity is defi...  
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Jan 17, 2018  |  Posted by: 

Requirements Traceability Matrix is a regulatory requirement for the life science industry. The Requirements Traceability Matrix (RTM) is a document that links requirements throughout the validation process. The purpose of the Requirements Traceability Matrix is to ensure that all requirements defined for a system are tested in the test protocols. The requirements traceability matrix is usually developed in concurrence with the initial list of requir...  
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Nov 20, 2017  |  Posted by: 

Commissioning and Qualification is a critical regulatory requirement for the life sciences industry. The purpose of commissioning and qualification is to ensure and provide documented evidence that facilities and equipment are qualified based on their intended use. Commissioning and qualification typically. includes the following activities and deliverables:
  • Commissioning Plan
  • Basis of Design
  • Syst...  
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