Reduce our customers’ total cost of ownership and validation by delivering consistently high quality products and supporting validation tools
Ensure consistency and documented objective evidence to support internal, customer and regulatory requirements
Contribute to Operational Excellence within BIOVIA to ensure high quality sustainable processes throughout the organization
BIOVIA QMS Department
The BIOVIA QMS Department is an independent compliance function with jurisdiction for software quality compliance across BIOVIA and it is mandated and supported directly by the CEO of BIOVIA. All part of Executive Leadership that signs off on projects, releases and QMS.
BIOVIA QMS Overview
The BIOVIA QMS is based on standards from the Food and Drug Administration (FDA) requirements and guidelines for software development, which inherently include elements from ISO 9000 and IEEE standards, and industry standard from the Good Automated Manufacturing Practice (GAMP) guide published by the International Society for Pharmaceutical Engineering (ISPE). It also takes into consideration the feedback of customers and employees.
Through mergers and acquisitions, BIOVIA consists of combined companies that had independent Quality Systems. The best of breed from each QMS were incorporated into what is now the BIOVIA QMS. BIOVIA’s expertise in QMS reaches back to 2004 when it was created by Symyx, one of the companies that formed Accelrys prior to the acquisition of Dassault Systèmes.
For more details access the BIOVIA Quality Statement here.
BIOVIA Solutions and QMS
BIOVIA’s solutions are designed to enable compliance to 21 CFR Part 11.
Regulatory checklists for risk assessment and reduction of validation efforts are available to our customers for the following products
According to GAMP 5 Software Categories, BIOVIA’s solutions fall under the category 4, configurable software.
BIOVIA QMS and Our Customers
On average BIOVIA is successfully audited once per month by customers across the industries we serve (Pharma, Consumer Packaged Goods, Chemicals, and Oil and Gas). During these audits BIOVIA discloses our Quality Management System for examination, along with evidence of our compliance. Customer requests and recommendations are considered and adopted as appropriate.
For support and product related discussions BIOVIA has established the BIOVIA Community as a communication platform for customers and BIOVIA employees.
BIOVIA QMS and Our Employees
BIOVIA conducts at least one internal audit per month ensuring the compliance of the different teams with our system and gathering their feedback to drive improvements of the system.
BIOVIA employees are also trained on relevant regulatory compliance regulations and guidelines to be able to provide customers with the best possible support in validation and consulting.