ValGenesis Blog
Philips needed a digital validation lifecycle management system that could standardize its paper-based computer system validation (CSV) efforts across multiple geographies.
Even in this paperless world, some continue to use outdated paper-based systems for validation. These holdouts create pain points that cost them time and money.
In a SaaS environment, data security often begins and ends with the actions and behaviors of company employees. Here are 3 tips to avoid a breach.
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.
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.
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.
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.
ValGenesis validation lifecycle management systems provide a solution that eliminates all the inefficiencies that plagued paper-based cleaning validation processes.
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.
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.
