Indegene assess regulatory compliance, frugality and richness of applied domain nuances in new or existing client technology systems, and deploy techno-functional and domain expertise to bridge performance and regulatory gaps, right from the start of the development cycle, thus identifying and assessing future risk areas and provide corrections after necessary validations & verifications.
Complete validation and verification of computer systems in-line with regulatory requirements across countries
Regulatory expertise for validation across CFR 21 Part 11, GxP, FDA – IQ/OQ/PQ, MHRA EU Annex 11, ePHI
Applied understanding of compliance requirements with respect to physician and patient data policies and procedures–HIPPA, Safe Harbor, EU, Data Protection
Preventive and corrective audits across different phases of software development lifecycle
Digital platforms validation across OWASP guidelines
Scalable across different platforms—digital, mobility, etc.