Overview

HCL is one of the early movers in the Life Sciences and Healthcare space. The Life Sciences practice at HCL started in 2002 and within a short span of time has emerged as the fastest growing vertical at HCL with a y-on-y growth of over 100%.

HCL’s Life Sciences practice at a glance:

Practice Highlights

Industry Segments	Pharmaceutical, Biotech, Medical Device, Healthcare Service Providers, Agri-business & ISVs
Quality and Processes	SEI CMM Level 5, BS 7799, ITIL, BS 15000
Certifications& Capabilities	ISO 13485; 2003, AAMI SW68-2001, ISO14971, IEC 60601 DICOM, HL7, HIPAA, 21 CFR Part 11, 21 CFR Part 820 & SOX Compliance
Memberships	DIA , CDISC, ACDM, SCDM, Adva Med
IPR & Solution frameworks	CliniCOTS, Panax Finder, RxCube, easy labeling, CrosSView ,ELM, MQMS,WIXA
Global Partnerships	Tokushima University, Supercomputing center for Bioinformatics & Computational Biology, IIT Delhi
Consultants	1500+ strong team of domain and technical consultants
Key Clientele	7 out of top 10 medical device companies
Domain-centric Approach-Consultants with 6-30 years work experience Customer facing AM/RM's from leading B-Schools like Kellogg's , Wharton , AIM-Manila, IIM's etc. Dedicated regulatory CoE with dedicated industry consultants from pharmaceutical, device and agribusiness sectors

HCL is the first Indian Company to have an ISO 13485 certification for design and development of medical devices. It is also one of the few offshore IT providers for the validation services. It has FDA compliant QMS. HCL is doing some high end work for designs across all classes of medical devices (class I,II, II) with focus on effective risk management flow for software hazard analysis, failure mode effect analysis and worst case and reliability analysis. HCL QMS is compliant to ISO 14971 for risk management. HCL QMS helps the team to prepare FDA submission ready documentation so that virtually no changes are required to the documentation after verification and validation.

HCL has been delivering significant value for its Life Science customers through the integrated package of process management, software services and infrastructure management. On a continuous drive for improvement and exceeding client expectations, HCL has been focusing on new ways of value creation:

• Multi-Service Integration And Service Innovation
• Business Outcome Based Pricing
• Innovative Partnership Structures
• Forward Looking Customers