Research & Development Biopharmaceutical Company
- Stringent adherence to GxP industry & operational governance of the Oracle environment.
- Increasing needs for access control and compliance with company growth and the implementation of more Oracle and non-Oracle workloads.
- Ability to partner with a hosting & managed services provider that is mature in operation, flexible in the expansion & contraction of contracts where required, & committed to the adherence to, audit & enforcement of GxP controls within their hosted environment.
- ITC migrated the Oracle-based environment to its data centers and provides tightly-controlled managed services through SSAE 18 SOC-1 and SOC-2 controls in addition to the enforcement of GxP governance.
- The partnership is flexible to accommodate the evolution of the customer’s business, providing the right infrastructure & personnel required to seamlessly allow the user community to focus on the business.
- Peace-of-mind from a solution provider adhering to its SSAE18 SOC1 and SOC_2 audited controls in conjunction with the customer’s governance & standards.
- EU GMP | 21CFR11 | FDA CFR | FDA SW VAL | FDA CDRH | GAMP5
- Process-driven, people independent, approach to compliance and support – proven, documented methodologies withstanding personnel turnover providing traceability & accountability for all business processes.
- Peace-of-mind from a solution provider adhering to its SSAE18 SOC1 and SOC_2 audited controls in conjunction with the customer’s governance & standards.GxP end-user training ensures consistent use of industry practices by across both organizations when working within the ITC hosted environment.
- Customized contract & SLA, prioritizing compliance without sacrifices in cost or quality:
- Scalable & flexible contract model tailored to the customer.
- Mature support model ensuring continual control compliance.
- Global, right-shoring personnel assignments, maximizing spend without losing quality.