Compliance & Validation

Validated and regulatory compliant approach: All required software and business support processes should meet local and country-specific validation and compliance standards. Our approach covers validated and regulatory compliant internal databases, SAS routines, modules and programming libraries for Phases I to IV trial data analysis to ensure consistency in data analysis and reporting across studies.
Health authority compliant procedures such as HL7, CDISC, CFRs (Part 11, etc.), cGLP, cGMP, cGXP, etc. are followed by the company in all its engagements.
Validation documents (IQ/OQ/PQs): Working with clients and their internal validation teams, we provide necessary IQs, OQs, PQs, validation plans, reports and summaries based on required SDLC parameters and the nature of the project.

Audit trial capture and reporting is necessary to comply with FDA’s CFR Part11 requirements. Working with clients, we provide necessary design, implementation and execution of system or process related events to be captured using necessary technology and database driven calls for analysis and reporting. Audit trails are also classified according to various categories based on the system and divisional context.
Related vocabulary and context sensitive help for medical professionals who are involved in using protocols and/or procedures in a specific therapeutic area. Our team has used automated tools to compile hyperlinked vocabulary and context sensitive help for association with a clinical trial module