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.
April 25, 2019
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.
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.