You create complex products with electrical, mechanical, software, and related specifications and procedures (documents). Managing a wide variety of documents and addressing regulatory compliance is critical, but it needs to be done in the context of the new product introduction process. Arena provides a better way to connect quality, training, CAPA, and compliance records directly to the product design record as you move from concept through commercialization. This product-centric approach removes silos and the need to integrate disparate document and product systems.
Some life sciences companies can get by with document-centric QMS solutions. However, life science companies with mechanical, electrical, and software components require a product-centric QMS approach to connect the entire product record to training, CAPA, and quality records. Leveraging a single system of record to manage the product and related quality processes simplifies compliance and speeds time to market.
Our product-centric QMS solution streamlines product realization processes with links to relational bills of materials (BOMs), engineering changes, and quality records to eliminate disconnected silos. Arena’s comprehensive quality management system improves management of Standard Operating Procedures (SOPs), Device Master Records (DMRs), and Design History Files (DHFs) to simplify compliance and reduce audit risks.
Document-centric QMS solutions require separate product management solutions requiring duplicate data entry. This results in data synchronization issues and confusion regarding where the latest product or quality information can be found. Arena eliminates the need for traditional stand-alone QMS systems.
For medical device companies, it is critical to have a quality system with a solid, connected product realization platform. Arena’s multi-tenant cloud solution streamlines product development and quality to give increased visibility and control to internal teams and external partners.
With Arena QMS, customers gain these strategic benefits:
Spend less time validating Arena with our complete package of requirements, impact analysis, protocols, execution records, reports, and validation knowledge base experts.
Software applications must be upgraded to meet your expanding business requirements, new technology, and industry demands.
Arena Validation Maintenance Service (VMS):