Available Now: InfoSQA10i

Software Development and Validation Software

Web application Access it from anywhere with a PC ad a browser Comes with flexible hosting options - on our servers or yours.

Contact us at info@makromed.com or 603-890-3311 x300 to conduct a convenient interactive evaluation now, using your existing PC with no demo programs or anything else to download.

InfoSQA 10i is a comprehensive software solution for managing product software development and QMS software validations in accordance with the FDA's 21 CFR Part 820.30 / 820.70 regulation and ISO 13 485 standard

General

• It allows managing all software development life cycle (SDLC) activities for product and QMS software.
• InfoSQA 10i provides a comprehensive approach to maintain and manage traceability for risk, requirements, design, testing, etc.

Product Software and QMS Software

• InfoSQA 10i allows creating and maintaining all essential elements of product and QMS software validations, including:
  • Assessment
  • Planning (Quality Plan, Risk Management, etc.)
  • Development (Requirements, Design, etc.)
  • Verification and Validation
  • System Release
  • System Deployment (IQ, OQ, PQ)
• Dynamically manages the traceability between different phases.

Other Advantages

• Supports attachment of external documents to each phase.
• It includes powerful smart tools like user configurable workflow rules and eNotifications for efficient and effective management of validation activities.
• It is fully validated, has comprehensive security features, includes elaborate audit trail functionality and is compliant with 21 CFR Part 11 eRecords and eSignatures regulation.
• It is web-based and can be conveniently accessed globally, including from mobile devices.

Click here to download a brochure on InfoSQA 10i Software Development/Validation software.