QUMAS offers a number of Packaged Solutions providing pre-defined & pre-tested configurations of Document content management or Process management for common industry problems.

Each Package is designed to address a specific business function and includes all required software, implementation services, training, and documentation to support that business function. Packages may be combined and built upon over time to address multiple areas of the business while maintaining a single, robust compliance platform.

Benefits of QUMAS Packaged Solutions

• QUMAS Packaged Solutions enable companies to get up and running with working solutions quickly and without long consulting engagements or expensive customizations. With a minimal upfront cost, every organization, no matter how small, can have access to world class solutions. By offering a hosted system, QUMAS reduces costs since a hardware investment is not required, enabling clients to have all the benefits of an electronic system with low overhead cost.
• QUMAS Packaged Solutions are ready to use out of the box and can be implemented, validated, and trained for go live all within 30 days. All of the configurations, materials, wizards and documentation required are supplied with the system. The solution is compatible with all existing documents, document management workflows, and processes, and all existing content will be automatically loaded into the system and validated before go live.
• Scalable solutions that grow as the company grows: implement for 10 users, and grow to 100s - QUMAS Packaged Solutions can be added to as the company grows, ensuring successful on-boarding while maintaining document control and regulatory compliance
• QUMAS Packaged Solutions meet GAMP 5 Category 3 definitions, making them significantly easier to validate and deploy
• QUMAS Packaged Solutions are pre-defined and pretested and are backed with 15+ years of experience in delivering compliance solutions to small and large pharmaceutical, biotechnology, and medical device companies
• QUMAS draws upon its years of industry experience in the design of the Packages and leverages its proven Services Methodology to ensure implementation success.

Click Here to Download the QUMAS Packaged Solutions Overview Brochure

QUMAS Packaged Solutions

QUMAS Packaged Solutions are based on the flagship QUMAS solutions QUMAS DocCompliance™ and QUMAS ProcessCompliance™. As an off-the-shelf regulatory content management system, DocCompliance ensures enterprise-wide consistency and compliance. ProcessCompliance is the premier application of its type, delivering pre-configured, built-in best practices for the management of a wide range of compliance and operational processes.

• QUMAS Quality Assurance Documents Package
  A DocCompliance based design to support creation, approval and ongoing management of Documentation for Quality purposes (Standard Operating Procedures, Methods, Specifications, etc.)
• QUMAS R&D Submission Documents Package
  A DocCompliance based design to support creation, approval and ongoing management of R&D Documentation for possible submission (Clinical, Non-clinical, CMC, Regional, etc.)
• QUMAS CAPA Process Package
  A ProcessCompliance based design to capture, manage & enable reporting of CAPA filings
• QUMAS Deviation Process Package
  A ProcessCompliance based design to capture, manage & enable reporting of Deviations
• QUMAS Change Control Process Package
  A ProcessCompliance based design to capture, manage & enable reporting of Change requests
• QUMAS CRO Documents Package
  A DocCompliance based design to support creation, approval and ongoing management of Documentation for CROs (Clinical, Non-clinical, Library, SOPs, Correspondence, etc.)
• QUMAS CMO Documents Package
  A DocCompliance based design to support creation, approval and ongoing management of Documentation for CMOs (CMC, SOPs, Methods, Specs, Correspondence, etc.)
• QUMAS Complaint Process Package
  A ProcessCompliance based design to capture, manage & enable reporting of Complaints
• QUMAS Audit Process Package
  A ProcessCompliance based design to capture, manage & enable reporting of Audits
• QUMAS Out-of- Specification Process Package
  A ProcessCompliance based design to capture, manage and enable reporting of concessions for raw or part finished materials that do not meet specifications
• QUMAS Medical Device Documents Package
  A DocCompliance based design to support creation, approval and ongoing management of documents used in the Medical Device sector (510k, Device master file, Design history file, etc.)