February 9, 2021
In the on-going COVID-19 pandemic, the U.S. Food and Drug Administration has postponed domestic and foreign routine surveillance inspections on a case-by-case basis; it is prioritizing mission-critical inspections that it seeks to conduct with appropriate safety measures in place.
January 21, 2020
Many validation projects invariably overrun budgets and fail to meet schedules. This conundrum often results in management eyeing validation costs suspiciously. Under cost containment pressures from management, there is a tendency to cut corners which results in an increased compliance risks.
December 19, 2019
This current era of biopharmaceutical manufacturing is a most challenging and exciting time for our industry. Technology breakthroughs, intensifying competition, and continually rising performance expectations from patients, stakeholders, pressure from government bodies for cost reduction, and regulators necessitate rapid change in execution.
May 9, 2019
Hello and welcome to the first installment of our new blog series, “Managing Cybersecurity in a SaaS Environment.” Throughout the year, we will be posting articles on various cybersecurity topics.
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 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.
September 28, 2017
ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.
March 13, 2017
Each of the above is important. However, the critical point is that data integrity should be designed into the system right from the beginning. Data integrity should be at the forefront of system development (i.e, design).
October 12, 2016
Paperless validation technology enables full compliance with data integrity regulatory expectations by eliminating the challenges found in paper-based validation processes.