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HCLT Whitepaper: The FDA’s New Enforcement of 21 CFR Part 11 Compliance (An Overview)

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http://www.hcltech.com/engineering-rd-services/overview - More Engineering R&D

Part 11 applies to all records that are defined in the underlying acts and regulations which govern activities in the life sciences industries. These underlying acts and regulations, which are referred to as the “predicate rules,” are any requirements set forth in the FDCA Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service Act), or any FDA regulation (GLP, GMP, and GCP). The predicate rules mandate what records are to be maintained, the content of those records, whether signatures are required, how long records must be maintained, and so on.

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  • 1. The FDAs New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012
  • 2. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview)June 2012 Contents About Validation ................................................................................ 3 Abbreviations .................................................................................... 4 FDA Regulation Along the Drug Life ................................................. 5 Other Challenges .............................................................................. 6 Modules/Steps Involved in the Validation Process ........................... 7 Module 1: Regulatory Requirements ................................................ 8 Module 2: Steps for Cost Effective Computer System Validation ... 11 Module 3: Initial and Ongoing Tests of Software and Computer Systems........................................................................................... 14 Module 4: Minimum Validation Documentation Validation .............. 15 Module 5: Qualification of Network Infrastructure and Validation of Network System .............................................................................. 16 Module 6: Understanding FDA Part 11 and the EU GMP Annex 11 ..... 17 Case Study ...................................................................................... 19 Conclusion....................................................................................... 20 Reference ........................................................................................ 21 Author Info ....................................................................................... 21 © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.
  • 3. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 About Validation Validation: Validation is defined as the act of testing for compliance with a standard. Need for validation in computer systems:  Required by regulations – US FDA, EMA, GMP, GCP, GLP  Ensures consistent data and product quality  Helps to protect intellectual property through scientifically sound data In 1997, the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. This was done in response to requests from the industry. With this regulation, titled Rule 21 CFR Part 11 (henceforth referred to as Part 11), electronic records can be equivalent to paper records and handwritten signatures. Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). Compliance is not as easy as it seems. The premise may seem straightforward, but implementing these regulations, adhering to them, and being able to document that the organization is compliant is quite complex. This paper provides you with information on HCL guidelines for Part 11. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.3
  • 4. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Abbreviations Sl. Acronyms Full Form No. 1. CFR Code of Federal Regulations 2. EU European Union 3. GMP Good Manufacturing Practices 4. AGMP (Automated Good Manufacturing Practices) 5. GLP Good Laboratory Practices 6. GCP Good Clinical Practices 7. GxP GLP+GCP+GMP = Predicate Rules 8. EMA European Medicines Agency 9. URS User Requirement Specification 10. PIC/S Pharmaceutical Inspection Convention/Cooperation Scheme 11. OQ Operational Qualification 12. DQ Design Qualification 13. PQ Performance Qualification 14. IQ Installation Qualification © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.4
  • 5. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 FDA Regulation Along the Drug Life  Application areas of 21 CFR Part 11 Part 11 applies to all records that are defined in the underlying acts and regulations which govern activities in the life sciences  Part 11 applies to all industries. These underlying acts and regulations, which are existing and newly referred to as the “predicate rules,” are any requirements set forth in installed systems the FDCA Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service Act), or any FDA regulation (GLP, GMP, and GCP). The predicate rules mandate what records are to be maintained, the content of those records, whether signatures are required, how long records must be maintained, and so on. Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule. Part 11 applies to all existing and all newly-installed systems. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.5
  • 6. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Challenges  Challenges to adhere to Part 11 A wave of change is sweeping through the life sciences industry. Electronic records and electronic signatures are replacing paper  Data integrity and records and hand-written signatures. The challenge is to comply information security with the regulations while implementing the most efficient and  Gap assessment effective systems possible. Although companies initially may resist moving toward compliance, the return on investment for accepting  Revenue loss the change is high. Likewise, the penalty for non-compliance can be severe. The regulation has been largely open to interpretation, resulting in many different compliance approaches. While the FDA is dictating what needs to be done, how it is to be done is left to individual companies. There are several problems or challenges associated with Part 11 in life science firms:  Part 11 is a regulation to promote public safety through an organization‟s ability to control data integrity with respect to authorized and unauthorized modifications to records. Data integrity and information security are the key objectives of Part 11.  To begin the move to compliance, a Part 11 gap assessment should be performed on all systems subject to records requirements set forth in the FDA regulations.  Failure to comply can lead to denial of a New Drug Application (NDA), potential delay in manufacturing, “483” warning letters, civil penalties, and even prosecution for negligence. These penalties, and the resulting delay in releasing new drugs, can cost life science firms millions of dollars. Steps for attaining initial compliance to Part 11 have been documented, which can help the organization achieve FDA compliance. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.6
  • 7. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Modules/Steps Involved in the Validation Process There are six steps involved in the validation process, which are listed below.  Regulatory requirements  Steps for cost-effective computer system validation  Initial and ongoing tests of software and computer systems  Minimum validation documentation inspectors want to see  Qualification of network infrastructure and validation of network systems  Understanding the spirit and basics of the FDA Part 11 and the EU GMP Annex 11 © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.7
  • 8. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Module 1: Regulatory Requirements  Steps to achieve regulatory Regulatory requirements require persons to “employ procedures requirements and controls, designed to ensure the authenticity, integrity, and confidentiality of electronic records, and to ensure that the signer  Computer system cannot readily repudiate the signed record as not genuine.” Various validation steps have been derived to satisfy these requirements.  Regulation and quality  Computer system validation standards  Regulation and quality standards  Validation of master plan  Validation master plan  Validation approach - lifecycle models  Validation approach – lifecycle models  Risk-based validation for records generated Computer System Validation Computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements. Systems that maintain certain employee training records may even be subject to validation. Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Validation is a systematic documentation of system requirements, combined with documented testing, demonstrating that the computer system meets the documented requirements. It is the first requirement identified in Part 11 for compliance. Validation requires that the system owner maintain the collection of validation documents, including requirement specifications and testing protocols. Regulation and Quality Standards The requirements in this part govern the methods, facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use, so they should satisfy: © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.8
  • 9. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012  GLP (Good Laboratory Practices)  GCP (Good Clinical Practices)  GMP (Good Manufacturing Practices)  AGMP (Automated Good Manufacturing Practices)  FDA‟s 21 CFR Part 11/EU Annex 11 (electronic records and signatures)  (Automated) equipment should be suitable for its intended use  Equipment should be routinely checked Validation Master Plan A Validation Master Plan (VMP) is an integral part of a well organized validation project. It documents the companys approach to complex validation projects. The VMP has a broad scope. It clarifies responsibilities, general objectives, procedures to be followed for validation, and it prioritizes multiple validation tasks. It may reference several protocols and procedures to be written in order to conduct the qualification of several different pieces of equipment and different processes. It may also specify schedules for validation and the allocation of resources needed to perform the validation. VMP provides a means of communication to everyone associated with the project. It lets management know how the company‟s resources are being allocated and when they will see the results. It tells the validation team what they have to do, when they have to do it, and gives them a means of tracking progress. Other groups can find out what the validation team is doing and what their roles are in support of the validation project. The FDA can look at the VMP and see the validation project is well thought out and organized; there is a logical reason for including or excluding every system from the validation project based on a risk analysis. Validation Approach – Lifecycle Models Validation is not a one-time event. Validation starts when you plan and design a product (hardware, software) or a method. Validation is finished when the product is retired and all data is successfully moved to a new system. Validation follows one of the lifecycle models. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.9
  • 10. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Risk-Based Validation Specific requirements for computers and electronic records and signatures are also defined in the FDA‟s regulations Part 11 on electronic records and signatures. This regulation applies to all FDA-regulated areas, and has specific requirements to ensure the trustworthiness, integrity and reliability of records generated, evaluated, transmitted and archived by computer systems. In 2003, the FDA published guidance on scope and applications of Part 11. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.10
  • 11. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 In this document, the FDA promoted the concept of risk-based  Steps to achieve cost validation. effective computer system validation Defined Actions for Risk Categories:  Form a project team  Document the user requirements Risk Business Continuity Compliance/Health Level  Develop a validation project plan Failure has a Failure of the system may  Conduct risk significant impact on cause harm to patients and assessment High delivery of products for there is no correction  Assess supplier several days possible  Installation qualification Failure has potential Failure of the system may to impact the delivery cause harm to patients and  Operational and Medium of products for 1 or 2 there is a good potential to performance days correct the failure qualification  Validation report Failure has negligible Failure of the system will not Low impact on product cause harm to patients delivery Module 2: Steps for Cost Effective Computer System Validation Form a Project Team which should include representatives from these key areas:  IT  QA  User groups  Validation groups, if applicable  Regulatory affairs  Documentation  Purchasing They should meet regularly to make critical decisions and communicate to a wider user base. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.11
  • 12. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Document the User Requirements which should be based on requirement specification, risk assessment and GMP impact. User requirements should be traceable throughout the lifecycle. The document should cover the below-mentioned points to address this requirement.  Contents  Justification for system  Intended application, e.g. electronic documents management  Intended environment (computer and network, operating environment, e.g. laboratory, manufacturing and office)  Process overview  Detailed user requirements  Signature and approval  When to write URS?  Who writes it, who approves it? Develop a Validation Project Plan which should define the activities, procedures and responsibilities for establishing the adequacy of the system. It should be derived from the company‟s validation master plan. There should be a specific strategy, approach, risk assessment, resources, responsibilities, activities and deliverables of the validation effort. It can be written in a table template or a flow text form, as shown below. Table Purpose of the plan Product description Validation strategy Responsibilities (position) Supplier assessment Risk assessment Testing strategies and reporting DQ IQ OQ PQ Traceability matrix Procedures Approval Documents and control © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.12
  • 13. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Conduct Risk Assessment Risk assessment should be applied throughout the lifecycle of the computerized system. As part of a risk management system, decisions on the extent of validation and data integrity should be based on a justified and documented risk assessment. The purpose is to optimize resources toward high-risk systems. Various inputs for risk assessment such as user experience with the same equipment already installed, user experience with similar equipment already installed, IT staff experience with the same or similar equipment, experience with the equipment vendor, information from the vendor on what can go wrong (during testing and ongoing use), etc. Assess Supplier The regulated user should take all responsible steps to ensure the system has been developed in accordance with an appropriate quality management system. The purpose is to determine the adequacy of the supplier quality system. Installation Qualification Collect the supplier‟s environmental conditions, operating and working instructions and maintenance requirements compare systems, as received, with the purchase order. System installation is according to vendor specifications such as servers, clients, licenses, and installation protocol. Install interfaces, e.g. an e-mail system with impact analysis. Design an overview with system drawings, e.g. data flow, and testing for successful installation. Check documentation for accuracy and completeness. Document all components with asset and serial numbers. Operational and Performance Qualification Ensure the system works in your environment and identify critical functions for the computer systems as defined in the functional and user environment specifications. Develop these as test cases for the functions and define acceptance criteria, or take advantage of the vendor‟s OQ package. Perform the test and evaluate results, compare with the acceptance criteria, and finally document the results. Ensure smooth application-specific operation and suitable performance of the complete system through the ongoing operation. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.13
  • 14. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Validation report It should include a brief description of each project activity used to review all preceding validation activities and indicate the status of the system prior to implementation into the production environment. Deviations from the project plan should be documented and a risk assessment should be performed. Module 3: Initial and Ongoing Tests of Software and Computer Systems A test should be developed, formally documented and used to demonstrate that the system has been installed and is operating and performing satisfactorily, and ensures that system requirements are met. Keep the test evidence on justified and documented risk assessment: keep hard copy screen prints for high impact functions. Consider testing of native functions carefully. The extent of testing should be based on risk, complexity and novelty. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.14
  • 15. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Module 4: Minimum Document Validation  List of documents for Documentation which inspectors want to see is listed below. validation  Documentation  Required SOPs (examples)  Supplier and service providers agreement  Suppliers and service providers assessment information  Supplier agreement  Data back-up  Back-up storage locations, validation, back-up frequency and documentation  Periodic evaluation and review of computer systems  Internal audits of computer system  Business continuity plan  Disaster recovery plan preparation  System retirement  Maintenance support Framework (corporate, site, department) For individual projects processes For individual products Test records © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.15
  • 16. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Module 5: Qualification of Network Infrastructure  Necessity for and Validation of Network System network infrastructure Why Care About Network Infrastructure?  Regulations for A well-qualified network infrastructure increases system uptime and validation of network reduces maintenance costs. Ensure that the network is qualified at infrastructure least once, and not for each application. Network infrastructure is subject to FDA/EU inspection. Regulation/Guidelines for Qualification/Validation of Network Infrastructure  The Gxps-system should be suitable for the intended use  21 CFR Part 11 – E-signatures/Records - Defines requirements for electronic records; electronic signatures in FDA regulated industries  PIC/s Good Practice Guide - Has lots of good recommendations on using computers in regulated environments © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.16
  • 17. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Module 6: Understanding FDA Part 11 and the EU  FDA Part 11 and the GMP Annex 11 EU GMP Annex 11 FDA Part 11 and the EU GMP Annex 11 insist on the below- compliance mentioned points: requirement Control of Closed System (11.10)  Validation  Accurate and complete copies  Protection and retrieval of records  Limited access to systems and data  Electronic audit trail  Authority checks  Device checks  Operational system checks  People qualification  Individual accountability  Controls over system documentation Digital Signatures (11.30)  Use of digital signatures for open systems Electronic Signatures (11.50, 11.70, 11.100, 11.13)  Requirements for signed electronic records  Linking records to signatures  Requirements for electronic signatures  Electronic signature components FDA 21 CFR Part 11 & EU GMP Annex 11: General Requirements for Electronic Signatures  E-signature must be unique. Ex: user ID and password, biometric devices  Identity of individuals must be verified  Identification code must be periodically checked, recalled and revised  Pass card must be periodically tested  Attempts at unauthorized access must be reported © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.17
  • 18. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012  The use of an e-signature must be certified with the FDA Annex 11 requires 1 and 2 along with the additional requirements below:  Risk management  Supplier and service provider management  Data entry and processing  Data accuracy checks  Change management  Periodic evaluation  Incident management  Batch release  Business continuity Regulation (Annex 11) For electronic records, regulated users should define which data are to be used as raw data. At least, all data on which quality decisions are based should be defined as raw data (EU Annex 11). Recommendation For hybrid systems, clearly define if electronic data or printouts are raw data. If printouts are defined as raw data, they should include all required records. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.18
  • 19. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Case Study The use of electronic records is expected to be more cost-effective for the industry and the FDA. The approval process is expected to be shorter and access to documentation will be faster and more productive. HCL has provided 21CFR Part 11 compliant assessment for many clients on various requirements. One of the case studies is mentioned below for reference. Client Requirement To create a validation plan for a universal testing machine with 21 CFR Part 11 compliance assessments. HCL Solution HCL created the validation plan and a tracking system to monitor the 21CFR Part 11 compliance requirement. The validation plan defines:  Validation strategy for providing the documented evidence necessary to demonstrate that the universal testing machine functions according to requirements  Roles and responsibilities to implement and to be maintained in validated state  Validation deliverables required to qualify the client process and FDA requirement Deliverables Required deliverables for the universal testing machine (UTM) validation plan are as follows:  Validation plan  Quality and regulatory assessment  21 CFR Part 11 coverage assessment  User requirements specification  Risk level and other risk documentation, e.g. PFMEA, if any. DFMEA and PFMEA documents were not required as the risk was medium, based on the risk assessment document.  Test cases for installation and user requirements  Requirement traceability matrix  Standard operating procedure  21 CFR Part 11 compliance assessment © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.19
  • 20. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 Conclusion The ultimate goal of computer system validation is to produce documentation that actually raises the quality instead of just producing more paper. Over the years, HCL has developed a step-by-step approach to computer system validation - 21 CFR Part 11 compliance. This step- by-step procedure adheres to the FDA rules to meet Part 11 requirements and to ensure the electronic records and electronic signatures are trustworthy, reliable and compatible with the FDA‟s public health responsibilities. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.20
  • 21. The FDA‟s New Enforcement of 21 CFR Part 11 Compliance (An Overview) June 2012 References  Code of Federal Regulations, Title 21, Food and Drugs, Part 11 Electronic Records; Electronic Signatures  L. Huber, “Validation of Computerized Analytical and Networked Systems”  FDA Guidance for Industry Part 11, Electronic Records; Electronic Signatures Scope and Applications  L. Huber, “Risk-Based Validation of Commercial Off-the-Shelf Computer Systems” Author Info Kannan Palaniappan – Kannan has over 10 years of experience in new product design and development on electro- mechanical products, including three and a half years of medical product design. He has worked in cryoablation system design and development, and orthopedics instrument and sterilization unit system development. Prasanna Kumar Thirunavukkarasu – Prasanna has over eight years of experience in new product design and development on electro-mechanical products that includes over a year in medical product design. He has worked in design and development of “energy- based devices” and orthopedic implants and instruments. © 2012, HCL Technologies, Ltd. Reproduction prohibited. This document is protected under copyright by the author. All rights reserved.21
  • 22. Hello, I’m from HCL’s Engineering and R&D Services. We enabletechnology led organizations to go to market with innovative productsand solutions. We partner with our customers in building world classproducts and creating associated solution delivery ecosystems to helpbring market leadership. We develop engineering products, solutionsand platforms across Aerospace and Defense, Automotive, ConsumerElectronics, Software, Online, Industrial Manufacturing, MedicalDevices, Networking & Telecom, Office Automation, Semiconductorand Servers & Storage for our customers.For more details contact eootb@hcl.comFollow us on twitter: http://twitter.com/hclersVisit our blog: http://ers.hclblogs.com/Visit our website: http://www.hcltech.com/engineering-services/About HCLAbout HCL TechnologiesHCL Technologies is a leading global IT services company, workingwith clients in the areas that impact and redefine the core of theirbusinesses. Since its inception into the global landscape after its IPO in1999, HCL focuses on „transformational outsourcing‟, underlined byinnovation and value creation, and offers integrated portfolio of servicesincluding software-led IT solutions, remote infrastructure management,engineering and R&D services and BPO. HCL leverages its extensiveglobal offshore infrastructure and network of offices in 26 countries toprovide holistic, multi-service delivery in key industry verticals includingFinancial Services, Manufacturing, Consumer Services, Public Servicesand Healthcare. HCL takes pride in its philosophy of Employees First,Customers Second which empowers our 83,076 transformers to createa real value for the customers. HCL Technologies, along with itssubsidiaries, has reported consolidated revenues of US$ 4 billion (Rs.19,412 crores), as on TTM ended Mar 31 12.For more information, please visit www.hcltech.comAbout HCL EnterpriseHCL is a $6.2 billion leading global technology and IT enterprisecomprising two companies listed in India - HCL Technologies and HCLInfosystems. Founded in 1976, HCL is one of Indias original IT garagestart-ups. A pioneer of modern computing, HCL is a globaltransformational enterprise today. Its range of offerings includesproduct engineering, custom & package applications, BPO, ITinfrastructure services, IT hardware, systems integration, anddistribution of information and communications technology (ICT)products across a wide range of focused industry verticals. The HCLteam consists of over 90,000 professionals of diverse nationalities, whooperate from 31 countries including over 500 points of presence inIndia. HCL has partnerships with several leading global 1000 firms,including leading IT and technology firms.For more information, please visit www.hcl.com