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A Novato, California headquartered, clinical-stage biotechnology company practicing treatment of serious, rare and ultra-rare diseases, sought to ensure 100% compliance to pharmaceutical guidelines.
- They were seeking a knowledgeable partner with expertise in fully compliant and validated SOC2 Type II - certified private cloud Hosting environment and managing services within the following standards: EU GMP | 21CFR11 | FDA CFR | FDA SW VAL | FDA CDRH | GAMP5
- More workloads in the Cloud increased the importance of compliance regulations such as controlled access and restrictions to instances, GxP training, and continuous audit compliance.
- Needed a partner providing high-quality managed services support within a validated, scalable infrastructure consistently adhering to government regulations.
The success story addresses their key compliance concerns, technical requirements, and existing business challenges solved by IT Convergence ensuring minimum end user disruption.
Read this case study to discover how IT Convergence Solved all IT compliance related issues for this company.