Facing increasing pressure on costs and margins, organizations in regulated industries must move away from tackling regulatory compliance with point solutions that address specific, individual regulatory challenges.
With a unified, consistent, holistic view of all compliance-related information across all functions you can:
Consolidate as many regulatory compliance activities as possible in a cohesive regulatory compliance environment to support real-time, actionable information and data integrity.
Identify the areas of greatest risk so you can target and address these risks appropriately and comply with state, federal and international government regulations.
QUMAS customers report
20-30% reduction in observations
40-50% reduction in FDA on-site inspection time
60-70% reduction in validation time and costs
QUMAS products have helped Hollister be a more nimble company. We now have much better visibility of compliance activities across the entire company and can see how a problem in one facility could potentially impact additional facilities, and then take the required steps to prevent the problem from occurring globally.
Dawn PorterCompliance Process Lead at Hollister Inc.
QUMAS is a validation-ready, closed-loop compliance solution with full capabilities around document and process management, just-in-time learning management, reporting and quality and business intelligence. QUMAS standardizes the entire range of enterprise document compliance and governance components in a comprehensive framework. The system provides an integrated view of your enterprise's compliance health, providing real-time oversight across all functions, as well as drill down to detailed, actionable incident information.
With QUMAS you can be confident that you are complying with GxP, FDA 21 CFR Part 11 as well as EU Annex 11 with Electronic Signatures and a fully compliant electronic audit trail. The system also supports the GMP imperative of Data Integrity and ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available data).
QUMAS provides reports and dashboards tracking key metrics including:
Where are the bottlenecks in my business?
Can we meet agreed-to Service Level Agreements?
Can I view information by site, product type, time period, etc.?