Validation Services
As end-to-end solution providers for companies in the Life Sciences sector, Intelligroup uses a “right-shoring” model which combines on-site, off-site and off-shore resources to provide validation services in a time and cost-effective manner. Intelligroup’s Validation Templates and Services in combination with our Business Process and Technology offering, allow our customers to focus on their core business. Our Compliance Kit formalizes this offering for maintaining systems in a validated state. With a proven track record of using FDA’s current approach to validation, using Risk Models, Intelligroup’s validation experts ensure that the effort is “right-sized”.

	Strategic Services
	Strategy for Computer System Validation
	Project Management Services
	Risk based Validation
	Risk Analysis and Risk Models
	VSD, VMP/VP, RA, VPP, RTM, IQ/OQ/PQ/Data Conversion Protocol and Summary, OQ/PQ Scripts, URS, FRS, DDS, VSR, SOPs, User Manual, System Manual
	Infrastructure Qualification
	IT Governance
	SOPs, Disaster Recovery/Business Continuity Plans, Operations Manual (Back-up / Recovery Procedures, Security, Monitoring, Support and Maintenance), User and Asset Repository.
	Computer System Quality Assurance
	Change Control Process definition and implementation
	Internal Audit Controls
	SDLC methodology and documentation
	Testing Services (right-shored)
	Integrated testing strategy
	Manual Testing
	Automated Testing
	eCATT
	Mercury Interactive
	Training
	Risk Analysis
	21 CFR Part 11
	Computer System Validation
	Implementation and Maintenance of ERP Systems in a regulated environment

Intelligroup’s validation services go well beyond generating reams of paper. With a focus on assuring system and process quality, Intelligroup validation methodology creates real value in time and cost efficiencies for the customer, while meeting compliance requirements.