LIFE SCIENCE & PHARMA
services that will exceed your needs and expectations
The Pharmaceutical and life sciences domain is observing a revolution in both business and technology. FDA regulations make it mandatory to perform Computer System Validation on some of the applications like Clinical Trials , Laboratory Information Management Systems (LIMS). Our best practices emphasizes on FDA guidelines (FDA regulations 21 CFR Part 11 , Part 820 and Part 58. ) in terms of validation, electronic records and signatures.
Life science and Pharmaceutical companies face new compliance challenges due to the changes in the industry landscape. With continuously evolving developments and increased regulations, there is a pressing need for agile software testing methodologies to address specific requisites.
Logix Guru helps clients not only in reducing the overall cost and increasing the efficiency but also in getting the products faster to the market. We provide Jump Start kits that address immediate requirements apart from our wide range of services. We also ensure that the systems meet industry standards and are compliant. Our consultants have wide ranging experience and use Industry's best practices in testing of IQ/OQ/PQ protocols and our test scripts/results are completely documented.
- Functional Automation
- Data migration
- Drug Development Laboratory Information Management Systems (LIMS)
- Research Content Management Software
- Clinical Trials LIMS
- Advanced Laboratory Testing Application
- Clinical Data Warehousing Solutions
- Electronic Data Capture System
REGULATORY STANDARDS EXPERIENCE:
- 21 CFR Part 11 Testing
- Quality Audits
- GxP's Standards Testing