February 5, 2018
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
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 20, 2017
Traditional commissioning and qualification can be very challenging due to the inefficiencies, compliance risk, lack of data integration, inability to adequately track and close out activities.
November 10, 2017
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
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.
September 28, 2017
ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.
August 30, 2017
Validation regulatory requirements are driven by regulations such as FDA 21 CFR Part 11, EU Annex 11 and many other country specific requirements for validation.
August 11, 2017
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
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.