Solutions for the Medical Device and Pharmaceutical Industries

Medical device and pharmaceutical manufacturers are challenged to comply with stringent FDA regulations for design controls and FDA guidelines for embedded software validation and verification. The net effect of these stringent regulations is that your competitive edge can be compromised by slow time-to-market windows.  IBM's modeling solutions help you manage these challenges and more.

Medical device and pharmaceutical manufacturers face key challenges, such as:

• Demonstrating compliance and traceability to strict FDA regulations such as 21 CFR Part 820.30
• Maintaining audit trails detailing the purchase plan, the request for proposals, the vendors' responses, the design input and output for the system, the software validation plan, and the test results that prove the software meets the requirements
• Proving to the FDA that potential risk factors have been mitigated to a satisfactory level and establishing comprehensive matrices thereof
• Verifying the authenticity of the data and records as per 21 CFR Part 11 with time-stamped signatures if electronic documents are used
• Meeting strict requirements for process, testing, and documentation which can expand development schedules and resources required for compliance.

Meet FDA regulations and improve efficiency, productivity and quality

To be successful, medical device and pharmaceutical manufacturers must optimize their systems development lifecycles for greater efficiency, productivity and quality. These organizations need a requirements management solution that enables traceability and reliability, while building confidence in their electronic data and development process, so they can satisfy FDA regulations like 21 CFR Part 11. With electronic signature capability, users can electronically sign baselines with a time-stamped, unalterable historical record of all the information - including traceability links and user comments.

Model-based development and Requirements Management can help medical device manufacturers demonstrate traceability from design input to design output and link tests and results to the design. Risk mitigation must be proven via Failure Mode Effects Analysis (FMEA) and Device Hazard Analysis (DHA). Standards-based modeling allows product developers to validate and verify the design, from initial concept to final deliverable, while developing detailed test components throughout the design process. Automatically generated reports that show thorough traceability among design elements will complete the Design History File (DHF).

Resources for medical device and pharmaceutical manufacturers

Requirements Management with electronic signature capabilities with Telelogic® DOORS® >>

Change Management with electronic signature capabilities with Telelogic® Change™ >>

Industry leading Model Driven Development (MDD) for real-time, embedded or technical systems and software development with Telelogic® Rhapsody® >>

Industry leading MDD for enterprise IT systems and software
including Services Oriented Architectures (SOA) applications with Telelogic® Tau® >>

Profiling, rule-checking, and coverage analysis for manually written code with Telelogic® Logiscope™ >>

Generate reports to demonstrate compliance to FDA regulations with Telelogic® DocExpress® >>