Pharmaceutical Technology Validation
Like other segments of the Life Sciences, pharmaceutical commercialization increasingly incorporates technology solutions which are subject to regulatory review. This includes solutions that support business operations and those that directly impact a product’s functionality, especially if that product relies on technology for its intended use.
Validation of computerized systems and equipment ensures your technology is appropriate for its intended use. Pharmaceutical technology validation may apply to a supporting device, supporting technology, software applications, as well as business applications.
At MethodSense, our technology and software experience grew from the development and productization of LuminLogic Smart Enterprise Suite. It’s been further refined through building custom applications for our clients and preparing numerous technology products for market authorization.
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
Our pharmaceutical technology validation and software validation services include:
- 21 CFR Part 11 and other electronic information assurance Title 21 compliance strategies
- Process and software validation development and execution
- Controls for technology management and compliance needs
- Technology assessments for procurement or acquisition