HCLT Whitepaper: Automation Of Pharma Regulatory Compliances In HL7 Environment

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The Pharmaceutical regulatory bodies receive massive amounts of clinical research data in extremely disparate formats using a variety of proprietary standards. This makes it extremely difficult, to do cross-study and application reviews. To overcome this problem, Food and Drug Administration (FDA) of United States of America has directed the industry to use Health Level Seven (HL7) Reference Information Model (RIM) towards a standardized approach to capture, receive, and analyze study data to ensure unambiguous exchange of healthcare information. This paper is intended to highlight how best LIMS can be integrated with HL7 interface in order to automate the exchange of electronic message with regulatory authorities.

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Pharmaceutical companies typically use a variety of complex software applications like: LIMS, ELN (Electronic Lab Notebook), ERP (Enterprise Resource Planning), CDMS/CTMS (Clinical Data Management Systems/ Clinical Trial Management System), HIS (Hospital Information System), SDMS (Scientific Data Management System), CMS (Content Management System) and so on from different vendors. Moreover, the health Information is currently being recorded with widely varying levels of detail and structure including text, audio and video files. This language barrier makes it impossible to exchange electronic information amongst the stated systems.

HCL’s LabIMS HL7MIDW module can help an organization in many ways other than automating electronic submission of regulatory information and electronic health record. These features include data exchange and interoperability between diverse organizations/ information systems, flexibly construction electronic messages combining various input systems and their presentation as per customer-specific rules (e.g. intensive care, cardiology, office practice in one country or primary care in another country), efficiently exchange multimedia files (Ex. Thin layer chromatography plate images, Spectral diagram, Chromatogram, or scanned documents/images etc.) and so on.

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HCLT Whitepaper: Automation Of Pharma Regulatory Compliances In HL7 Environment

  1. 1. January 2011 AUTOMATION OF PHARMAREGULATORY COMPLIANCES IN HL7 ENVIRONMENT
  2. 2. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011ContentsAbstract 2Business Problem 3Challenges in building HL7 interface 3Creating communication with HL7 Interface Engine 3Deliverables to FDA using HL7 interface engine 5HL7MIDW- a tool to solve business issues 6HL7 based regulatory information exchange automation throughLIMS 7Solution beyond regulatory compliance 7Conclusion 7References 8About the Author 9ABOUT HCL 10AbstractThe Pharmaceutical regulatory bodies receive massive amounts ofclinical research data in extremely disparate formats using a varietyof proprietary standards. This makes it extremely difficult, to docross-study and application reviews. To overcome this problem,Food and Drug Administration (FDA) of United States ofAmerica has directed the industry to use Health Level Seven(HL7) Reference Information Model (RIM) towards a standardizedapproach to capture, receive, and analyze study data to ensureunambiguous exchange of healthcare information. Moreover, in2009, International Conference on Harmonization (ICH) indicatedthat Regulated Product Submission standard (RPS) of HL7 wouldbecome the next major version (NMV) of Electronic CommonTechnical Document (eCTD). European Medicines Agency (EMA)is working also planning for implementation of RPS. Regulatoryagencies from Europe, Canada, and Japan are at varying levels ofinterest and participation. As the laboratory test data and the relatedinformation constitute the major component of regulatory dataexchange, Laboratory Information Management System (LIMS)systems serving pharmaceutical industry must be able to exchangeinformation in HL7 format. This paper is intended to highlight howbest LIMS can be integrated with HL7 interface in order to automatethe exchange of electronic message with regulatory authorities.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  3. 3. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011Business ProblemPharmaceutical companies typically use a variety of complexsoftware applications like: LIMS, ELN (Electronic Lab Notebook),ERP (Enterprise Resource Planning), CDMS/CTMS (Clinical DataManagement Systems/ Clinical Trial Management System), HIS(Hospital Information System), SDMS (Scientific Data ManagementSystem), CMS (Content Management System) and so on fromdifferent vendors. Moreover, the health Information is currentlybeing recorded with widely varying levels of detail and structureincluding text, audio and video files. This language barrier makesit impossible to exchange electronic information amongst thestated systems. In order to reduce this complexity, there is a needof universal framework which will connect the systems withoutmuch trouble. As mentioned earlier, when we talk about regulatoryinformation exchange in HL7 format, LIMS systems are the mostimportant system to be integrated with an inbuilt HL7 interfaceengine.Challenges in building HL7 InterfaceThere are several challenges to building HL7 interfaces. An HL7interface requires a sending and receiving module in HL7 messageformat. Communicating applications may use HL7 or any othermessage format. Even when both applications use the HL7 messageformat, they rarely agree on the specific HL7 format that is used. Inorder to bridge the differences in messaging format, modificationsneed to be made to the sending or receiving modules or an interfaceengine is used in the middle to translate the messages.Creating communication with HL7 Interface EngineAn interface engine is designed to simplify connecting, maintaining,monitoring, and sharing data between interfaces. An interface enginecan take data from a sending application and filter it or change theformat of the data to match each individual application’s needs. Thisfeature greatly reduces the number of individual endpoints requiredto communicate between applications which in turn, saves on theprice of implementing of an integrated system.An HL7 interface includes:• An export endpoint for the sending application• An import endpoint for the receiving application• A method of moving data between the two endpoints© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  4. 4. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011The following schematic diagram (Figure A) shows an interfacebetween the Pharmaceutical organization and the regulatory bodythrough a HL7 interface engine (HL7MIDW). Pharmaceutical Regulatory Organisation HL7MIDW Agency Fig A: Schematic diagram of HL7 interface engineWhen the above diagram is translated into real life example, thefollowing diagram shows how variety of LIMS applications, ERP/CDMS/HIS etc use this interface engine to communicate data withregulatory body like FDA. On a separete note, this model can beextended to develop a intersystems middleware too (Figure B). HL7 version A LIMS1 HL7 version B LIMS2 HL7MIDW FDA XYZ Messaging ERP/CDMS/HIS Format Figure B: HL7 Interface Engine Leveraging DataIn the above figure the interface engine leveraged the data in thefollowing manner:First, it receives one message each from three different applicationsthe LIMS1, LIMS2 and ERP/CDMS/HIS using various messagingformat. Then the engine filters and compiles the data to send it asper the needs of the FDA in HL7 format.Reverse thing is also possible when the information received by thisinterface engine from FDA can be filtered for specific applications.Next, the engine puts the data into different formats by using amap to translate the received format into the format needed for thereceiving application.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  5. 5. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011Deliverables to FDA using HL7 interface engineA “LIMS-HL7 interface engine” can help the pharmaceutical industryin this regard by streamlining submission of regulatory informationwith two-way electronic communication as per HL7 standard andallowing interoperability within the organization. Various FDAregulatory data exchange forms and their management throughHL7MIDW are summarized in the following figure: Clinical Research study design, study participation and subject data CTMS/CDMS Individual Case Safety Report LIMS Structured Product Lebeling HIS HL7MIDW Annotated ECG waveform Data Regulatory Product Submission ERP Product Stability Data (eStability) Other Applications Electronic Health Record Pharmaceutical FDA DATA EXCHANGE STANDARD Industry BASED ON HL7 RIM Figure C: Deliverables to FDA using HL7 interface engineIt is evident from the above figure that there are at least 7 varioustypes of information/reports to be submitted to FDA. They are:• Clinical Research study design, study participation and subject data report• Individual Case Safety Report• Structured Product Labeling• Annotated ECG waveform Data• Regulatory Product Submission• Product Stability (eStability) report• Electronic health record© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  6. 6. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011Moreover information exchange is an iterative process requiringinformation sending, updating, correction, addition/deletion fromtime to time. HL7MIDW has to extract and pool data from varioussystems including CTMS/CDMS, HIS, LIMS, ERP to generaterequired regulatory report. Again the information received inresponse from regulatory body has to be filtered and directedtowards specific applications. The whole process can be summarizedin the following diagram: FDA/ICH/EMA/Other Regulatory Agencies CTMS/CDMS CTMS/CDMS LIMS LIMS HIS HIS ERP ERP Other Applications Other Applications Organization A (US) HL7MIDW: Organization A (Europe) HL7 Interface CTMS/CDMS Engine CTMS/CDMS LIMS LIMS HIS HIS ERP ERP Other Applications Other Applications Organization B Organization C Figure D: Regulatory information exchange with FDA and inter-operatibility using HL7 interface engineHL7MIDW- a tool to solve business issuesIn submitting an eStability of a pharmaceutical company report toFDA, HL7MIDW can extract and pool data from various systemsof that organization like LIMS, ERP, CTMS etc, form and send thereport to FDA in HL7 format. FDA in return, when acknowledgethe acceptance through an HL7 message, HL7MIDW will accept,interpret and direct it to ERP system in its native format for storingit.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  7. 7. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011HL7 based regulatory information exchangeautomation through LIMSHL7 messaging exchange functions can be incorporated into thebasic LIMS core through a HL7 middleware module- HL7MIDWto construct HL7 messages flexibly on a segment by segment basisas per the customer-specific rules. This will allow HL7 messageexchange automation with regulatory authorities, within/betweenorganizations, and will facilitate interoperability between diverseinformation management systems through HL7 messaging exchange.Moreover its service will not be confined to a particular LIMS onlyand can be used as a compatible stand alone plug-in tool with anyother LIMS, making it capable of HL7 messaging exchange.Recently HCL has launched a revolutionary LIMS “LabIMS”, a OneShop Solution for Complete Laboratory Automation InformationManagement. It contains along with all the basic LIMS features;added functionalities like ‘Low cost solution’, ‘Robust and flexibleSaaS (Software as a service) based architecture’, ‘Repeatable andeasy to rollout’, ‘Single-Sign-on’. LabIMS is capable of automatingpharma regulatory message exchange in HL7 environment throughits inbuilt HL7MIDW module.Solution beyond regulatory complianceHCL’s LabIMS HL7MIDW module can help an organization in manyways other than automating electronic submission of regulatoryinformation and electronic health record. These features includedata exchange and interoperability between diverse organizations/information systems, flexibly construction electronic messagescombining various input systems and their presentation as percustomer-specific rules (e.g. intensive care, cardiology, office practicein one country or primary care in another country), efficientlyexchange multimedia files (Ex. Thin layer chromatography plateimages, Spectral diagram, Chromatogram, or scanned documents/images etc.) and so on.ConclusionIt can be concluded that, in present scenario, information exchangeautomation in HL7 messaging format are must for pharmaceuticalindustry to manage regulatory compliances. HCL’s LabIMS LIMSsolutions integrated with HL7MIDW module can help them in thismatter along with a large number of additional outstanding featuresas bonus!© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  8. 8. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011References1. www.hl7.org, retrieved on 22.10.2010, © HL7.2. Lilliam Rosario, FDA Data Standards: An Update.© drug information association.3. Ann Neuer (June 22, 2009). “Will Regulated Product Submission (RPS) Trump eCTD?” Bio-IT World.4. HL7 Introduction, Messaging and Theory; Copyright© 2008 OTech, Inc.5. h t t p : / / w w w . f d a . g o v / F o r I n d u s t r y / D a t a S t a n d a r d s / StudyDataStandards/, retrieved on 22.10.2010 © FDA.6. Lilliam Rosario. FDA Data Standards: An Update; Drug Information association, November 20097. An Introduction to Structured Product Labeling, Aug 2009, Product Development Company8. “ICH-HL7 Regulated Product Submissions”. GlobalSubmit. com. 2009.9. Ann Neuer (June 22, 2009). “Will Regulated Product Submission (RPS) Trump eCTD?”. Bio-IT World. http://www.bio-itworld. com/news/2009/06/23/RPS-trumps-ectd.html.10.“RCRIM Project Proposal–Regulated Product Submission”. hl7. org. May 2005.11.“HL7 Regulated Product Submissions Goals and Scope”. hl7. org. 21 April 200612.Electronic Health Records Overview© 2006, The MITRE Corporation, McLean, Virginia.13.Donald T. Mon. HL7 EHR System Functional Model and Standard HIMSS Annual Conference, March, 201014.Why Do I Need an Interface Engine? http://www. corepointhealth.com/whitepapers/why-do-i-need-hl7-interface- engine, @ corepointhealth.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  9. 9. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011About the Author Anindya Bose is working as a Senior Business Analyst and Pharma domain ezxpert in Lab Automation COE under Healthcare Practice, HCL Technologies Ltd. Before joining HCL Technologies, he worked for more than 8 years as Lecturer and Assistant Professor in Institute of Pharmacy and Technology, Salipur, India. Anidya has a Ph.D degree in Pharmaceutical Technology from Jadavpur University, Kolkata and is author of more than 30 research publications in various reputed international journals. He is an associate fellow of Indian Institute of Chemists and an editorial member of International Journal of Research in Phytochemistry Pharmacology.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.
  10. 10. 10AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011ABOUT HCLHCL 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 itsIPO in 1999, HCL focuses on ‘transformational outsourcing’,underlined by innovation and value creation, and offers integratedportfolio of services including software-led IT solutions, remoteinfrastructure management, engineering and RD services andBPO. HCL leverages its extensive global offshore infrastructureand network of offices in 29 countries to provide holistic, multi-service delivery in key industry verticals including FinancialServices, Manufacturing, Consumer Services, Public Services andHealthcare. HCL takes pride in its philosophy of ‘Employees First’which empowers our 70,218 transformers to create a real value forthe customers. HCL Technologies, along with its subsidiaries, hadconsolidated revenues of US$ 2.9 billion (Rs. 13,145 crores), as on30th September 2010 (on LTMbasis).About HCL EnterpriseHCL is a $5.5 billion leading global technology and IT enterprisecomprising two companies listed in India - HCL Technologies andHCL Infosystems. Founded in 1976, HCL is one of India’s originalIT garage start-ups. A pioneer of modern computing, HCL is aglobal transformational enterprise today. Its range of offeringsincludes product engineering, custom package applications,BPO, IT infrastructure services, IT hardware, systems integration,and distribution of information and communications technology(ICT) products across a wide range of focused industry verticals.The HCL team consists of over 77,000 professionals of diversenationalities, who operate from 29 countries including over500 points of presence in India. HCL has partnerships with severalleading Global 1000 firms, including leading IT and technologyfirms. For more information, please visit www.hcl.in.© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

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