Quality & Regulatory Assurance
Our end-to-end services ensure risk-based, right-sized GxP compliance.
Risk-based compliance for life sciences
Changes in technology have made achieving compliance more complex, yet more important than ever. New solutions like IoT, cloud-based SaaS, mobile access to regulated data and decentralized clinical trials have made risk complicated.
NTT DATA offers proven processes and approaches that help life sciences organizations achieve the adaptability that’s crucial to compliance today. We build and improve your approach to compliance with extensive experience and deep knowledge of industry standards like GAMP (Good Automated Manufacturing Practice).
What we do
Advisory Services
Experience in regulatory assurance and compliance & validation, and guidance in computer software assurance, risk/gap analyses, merger acquisition & divestiture activities, audits, risk assessments and system & process consulting.
SAP S/4HANA
Get risk-free expert validation services for a move to SAP S/4HANA. A process-oriented approach delivers a documented, proven, stable and validated platform for an intelligent enterprise with the strong digital core of SAP S/4HANA
Staffing
Augment your staff with industry trained and seasoned professionals for all key roles in the validation processes including manager, analyst, test manager, test analyst and more.
Life Cycle Management
Our operational regulatory assurance and compliance services ensure maintenance of a validated state. Our key areas of focus include core functions, monitoring, assessments and improvements.
Validation Services
Get comprehensive validation as a service, infrastructure qualification services, test automation and tool qualification/validation services.
ServiceNow
Industry-leading ServiceNow capabilities with proven life sciences experience including CORE and validated implementations.
Qualified Hosting Infrastructure
Fully qualified secure infrastructure offerings including PaaS, IaaS, VPC, AWS gateway and more.
Right-sized compliance, built for today
Achieve GxP compliance with risk-based validation and proven regulatory expertise.