Technology Validation for Biotech Products
Biotech product commercialization increasingly incorporates technology solutions which are subject to regulatory review. This includes solutions that support business operations and those that directly impact your product’s functionality.
Validation of computerized systems, equipment and electronically supported products ensures that they operate as intended in support of your business. Technology validation for biotech products applies to the device itself, supporting technology, software applications, as well as business software and technology.
Implementing a technology management program helps you:
- Attain regulatory compliance
- Identify potential risk factors
- Reduce application development time
- Improve business efficiency
- Provide a qualified, third-party analysis of your systems
At MethodSense, our technology and software experience grew from the development and productization of InfoStrength Smart Enterprise Suite. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization.
Our regulatory software and technology validation services for biotech products include:
- 21 CFR Part 11 and other Title 21 compliance strategies
- Product Safety 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