What we do:
Compliance-ready Solutions:
While the final responsibility for validating computer systems lies with end users, Intelligroup’s ERP solutions and services for the Life Sciences industry such as Pharma Express and Chargeback 2.0 are delivered compliance ready with template validation packages and tools that can be used to validate the system quickly and efficiently.

Compliance Services
Companies with a presence in the US market need to comply with 21 CFR, HIPAA, and SOX. Additionally, companies need to comply with local regulatory bodies, and those competing for global markets need to comply with regulations from EMEA, FDA, JMHLW and others. As a company with a global presence and local domain expertise, Intelligroup leverages on commonalities in the cross compliance matrix to offer services that help clients meet compliance requirements from the drug discovery phase through Manufacturing and distribution.

Internal and Vendor Audits
A third-party audit of a company’s quality processes and documentation can help to quickly identify regulatory risk areas. Intelligroup examines the company’s computer system quality and validation processes, adherence to internal procedures, and determines whether regulatory expectations are being met. Intelligroup also performs partner and vendor computer system audits in a lead or support role. Intelligroup’s audit services start with an audit report and can extend through a corrective and preventative action plan. Assessments are made with special emphasis on:

	cGxP
	21 CFR Part 11
	Validation documentation
	Training

Validation Services
As end-to-end solution providers for companies in the Life Sciences sector, Intelligroup uses a “right-shoring” model which combines onsite, offsite and offshore 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 the 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

With a focus on assuring system and process quality, Intelligroup's validation methodology creates real value in time and cost efficiencies for the customer, while meeting compliance requirements.