Life Science product commercialization increasingly incorporates technology solutions subject to regulatory oversight. This can include solutions that support business operations and those that directly touch your product portfolio.

Recently, regulators across the globe have placed increasing pressure on life science companies to demonstrate that their technologies preform safely and as intended. The de-emphasis of 21 CFR Part 11 in recent history, however, has created knowledge gaps in this domain, making it difficult for many companies to respond effectively to auditors’ demands.

MethodSense’s technology and software management expertise grew from its development and productization of the InfoStrength Smart Enterprise Suite, a life science business solution. It was further refined through the building of multiple custom software applications and the preparation of numerous technology products for market authorization. Our expertise in this domain is instantly applied to our clients’ environments to ensure the success of any related initiative.

Our deep technology expertise includes:

• 21 CFR Part 11 and Part 820 compliance strategies
• Product Safety testing and EMC testing management
• Process and software validation development and execution
• Design of Software Controls for compliance needs
• SDLC methodology optimization
• Technology assessments for procurement or acquisition