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ValGenesis Blog (3)

The ValGenesis blog is dedicated to the best practices, insights and trends in validation for the life sciences industry. (3)

February 5, 2018

Validation Data Integrity

During validation, a significant amount data and information is generated during the lifecycle of GMP systems that requires data integrity. This data and information includes validation lifecycle data for critical manufacturing equipment, process control systems, laboratory instruments and computer systems.

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.

November 10, 2017

Blockchain and Data Integrity

First, let’s talk about blockchain, which is a bunch of blocks linked together. Each block contains data which can be linked to another block, forming a block chain.

October 17, 2017

Paperless 3 Stage Process Validation Lifecycle Approach

ValGenesis provides a solution that eliminate all the inefficiencies that plagued paper-based process validation. ValGenesis eliminates paper based process validation activities and enable the provides an integrated centralized repository of data and information during the process validation lifecycle.

August 11, 2017

Challenges with Traditional Cleaning Validation

Cleaning validation traditionally is a manual inefficient paper-based process that is plagued with inadequate cycle times and high cost. There is a significant amount of challenges and compliance risk associated with paper-based cleaning validation.

July 26, 2017

How to overcome the Subjectivity of Objective Evidence

A VLMS replaces paper-based, manual processes with paperless electronic records, electronic signatures, and the ability to enforce compliance through programmatic controls. In other words, a computer system can enforce rules.