Computer system validation is one of the standard tasks in the life science industry for maintaining the required compliance (on the part of EMA and FDA; GMP, GAMP, 21 CFR Part 11 or 820, 13485 etc. to name a few). The validation process is like a Sisyphean task, because with every software change – for example, through hotfixes, patches or other functional adjustments – the process starts anew. The entire process of handling countless document types is extremely time and resource intensive and even today is still predominantly paper-based and characterized by analog signature runs. Especially now in a decentralized and dispersed home office working world, new approaches to validation are needed.
VxP is a cloud-based Validation Platform from DHC Business Solutions for automating validation processes and digitally managing validation documents. The pre-validated solution is immediately available, easy to use and includes all relevant document/object types, templates, workflows and also reports for efficient and compliant management of validation documents. In order to maintain the valid status in system operation and to keep the documentation permanently up-to-date in the event of changes, VxP also has all the necessary procedures for the controlled management of changes, deviations, measures and CAPAs.
“VxP simplifies and accelerates the validation process with maximum compliance security. Being paperless, all activities can be carried out mobile and decentralized at any time. Interactive business and data analytics functions, the appealing design combined with controlled processes we call ‘Validation Intelligence’”., says Thorsten Claus-Martiny, Director DHC Business Solutions.
VxP digitizes the entire validation life cycle. Planning, definition, specification, risk analysis, test planning and execution as well as reporting are fully supported. Methodically, the solution is aligned with the V-model according to GAMP®. VxP complies with the GxP guidelines, is Part11-compliant and meets the IT compliance requirements of, for example, the EMA or FDA. Other regulatory requirements often include EN GMP Annex 11 regulations or ISO 13485 for computer system validation.
“The issue of CSV has been with DHC Group companies for many years”, explains Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions. “For many years we have been providing our customers with so-called Validation Accelerators for the DHC VISION software; not only all relevant validation templates, but also the necessary content. This significantly reduced the validation expenditure for our customers,” continues Kraemer.
He adds: “Last year, we went one step further and expanded this content offering to include Managed Validation Services. We take over the validation for our customers almost completely! The validation expenditure for DHC VISION is thus reduced to an absolute minimum. The technological basis for this is the cloud-based Validation Platform VxP, which has already been in use at DHC for several years.”
This solution is now available to customers in the life science industry and interested partner companies as a stand-alone product for the validation of ERP systems, QMS, LIMS, CAQ or clinical trail software and the like. Whether short-term for a project or longer-term initially in a department or at a site. VxP adapts quickly and easily across companies, countries, or the entire enterprise. The Validation Platform dynamically grows with the requirements to a central platform for all global validation activities.
Thorsten C.-Martiny: “The initial validation and maintenance of the valid state in case of changes or deviations is usually still associated with enormous testing and documentation expenditure and potential for errors. We will change this in the future.”