January 2011 AUTOMATION OF PHARMA REGULATORY COMPLIANCES IN HL7 ENVIRONMENT

Transcription

1 January 2011 AUTOMATION OF PHARMA REGULATORY COMPLIANCES IN HL7 ENVIRONMENT

2 Contents Abstract 2 Business Problem 3 Challenges in building HL7 interface 3 Creating communication with HL7 Interface Engine 3 Deliverables to FDA using HL7 interface engine 5 HL7MIDW- a tool to solve business issues 6 HL7 based regulatory information exchange automation through LIMS 7 Solution beyond regulatory compliance 7 Conclusion 7 References 8 About the Author 9 ABOUT HCL 10 Abstract 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. Moreover, in 2009, International Conference on Harmonization (ICH) indicated that Regulated Product Submission standard (RPS) of HL7 would become the next major version (NMV) of Electronic Common Technical Document (ectd). European Medicines Agency (EMA) is working also planning for implementation of RPS. Regulatory agencies from Europe, Canada, and Japan are at varying levels of interest and participation. As the laboratory test data and the related information constitute the major component of regulatory data exchange, Laboratory Information Management System (LIMS) systems serving pharmaceutical industry must be able to exchange information in HL7 format. 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.

3 Business Problem 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. In order to reduce this complexity, there is a need of universal framework which will connect the systems without much trouble. As mentioned earlier, when we talk about regulatory information exchange in HL7 format, LIMS systems are the most important system to be integrated with an inbuilt HL7 interface engine. Challenges in building HL7 Interface There are several challenges to building HL7 interfaces. An HL7 interface requires a sending and receiving module in HL7 message format. Communicating applications may use HL7 or any other message format. Even when both applications use the HL7 message format, they rarely agree on the specific HL7 format that is used. In order to bridge the differences in messaging format, modifications need to be made to the sending or receiving modules or an interface engine is used in the middle to translate the messages. Creating communication with HL7 Interface Engine An interface engine is designed to simplify connecting, maintaining, monitoring, and sharing data between interfaces. An interface engine can take data from a sending application and filter it or change the format of the data to match each individual application s needs. This feature greatly reduces the number of individual endpoints required to communicate between applications which in turn, saves on the price 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

4 The following schematic diagram (Figure A) shows an interface between the Pharmaceutical organization and the regulatory body through a HL7 interface engine (HL7MIDW). Pharmaceutical Organisation HL7MIDW Regulatory Agency Fig A: Schematic diagram of HL7 interface engine When the above diagram is translated into real life example, the following diagram shows how variety of LIMS applications, ERP/ CDMS/HIS etc use this interface engine to communicate data with regulatory body like FDA. On a separete note, this model can be extended to develop a intersystems middleware too (Figure B). LIMS1 HL7 version A LIMS2 HL7 version B HL7MIDW FDA ERP/CDMS/HIS XYZ Messaging Format Figure B: HL7 Interface Engine Leveraging Data In the above figure the interface engine leveraged the data in the following manner: First, it receives one message each from three different applications the LIMS1, LIMS2 and ERP/CDMS/HIS using various messaging format. Then the engine filters and compiles the data to send it as per the needs of the FDA in HL7 format. Reverse thing is also possible when the information received by this interface engine from FDA can be filtered for specific applications. Next, the engine puts the data into different formats by using a map to translate the received format into the format needed for the receiving application.

5 Deliverables to FDA using HL7 interface engine A LIMS-HL7 interface engine can help the pharmaceutical industry in this regard by streamlining submission of regulatory information with two-way electronic communication as per HL7 standard and allowing interoperability within the organization. Various FDA regulatory data exchange forms and their management through HL7MIDW are summarized in the following figure: CTMS/CDMS Clinical Research study design, study participation and subject data Individual Case Safety Report LIMS Structured Product Lebeling HIS HL7MIDW Annotated ECG waveform Data ERP Regulatory Product Submission Other Applications Product Stability Data (estability) Electronic Health Record Pharmaceutical Industry FDA DATA EXCHANGE STANDARD BASED ON HL7 RIM Figure C: Deliverables to FDA using HL7 interface engine It is evident from the above figure that there are at least 7 various types 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

6 Moreover information exchange is an iterative process requiring information sending, updating, correction, addition/deletion from time to time. HL7MIDW has to extract and pool data from various systems including CTMS/CDMS, HIS, LIMS, ERP to generate required regulatory report. Again the information received in response from regulatory body has to be filtered and directed towards specific applications. The whole process can be summarized in the following diagram: FDA/ICH/EMA/Other Regulatory Agencies CTMS/CDMS LIMS HIS ERP Other Applications CTMS/CDMS LIMS HIS ERP Other Applications Organization A (US) CTMS/CDMS LIMS HIS ERP Other Applications HL7MIDW: HL7 Interface Engine Organization A (Europe) CTMS/CDMS LIMS HIS ERP Other Applications Organization B Organization C Figure D: Regulatory information exchange with FDA and inter-operatibility using HL7 interface engine HL7MIDW- a tool to solve business issues In submitting an estability of a pharmaceutical company report to FDA, HL7MIDW can extract and pool data from various systems of that organization like LIMS, ERP, CTMS etc, form and send the report to FDA in HL7 format. FDA in return, when acknowledge the acceptance through an HL7 message, HL7MIDW will accept, interpret and direct it to ERP system in its native format for storing it.

7 HL7 based regulatory information exchange automation through LIMS HL7 messaging exchange functions can be incorporated into the basic LIMS core through a HL7 middleware module- HL7MIDW to construct HL7 messages flexibly on a segment by segment basis as per the customer-specific rules. This will allow HL7 message exchange automation with regulatory authorities, within/between organizations, and will facilitate interoperability between diverse information management systems through HL7 messaging exchange. Moreover its service will not be confined to a particular LIMS only and can be used as a compatible stand alone plug-in tool with any other LIMS, making it capable of HL7 messaging exchange. Recently HCL has launched a revolutionary LIMS LabIMS, a One Shop Solution for Complete Laboratory Automation & Information Management. It contains along with all the basic LIMS features; added functionalities like Low cost solution, Robust and flexible SaaS (Software as a service) based architecture, Repeatable and easy to rollout, Single-Sign-on. LabIMS is capable of automating pharma regulatory message exchange in HL7 environment through its inbuilt HL7MIDW module. Solution beyond regulatory compliance 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. Conclusion It can be concluded that, in present scenario, information exchange automation in HL7 messaging format are must for pharmaceutical industry to manage regulatory compliances. HCL s LabIMS LIMS solutions integrated with HL7MIDW module can help them in this matter along with a large number of additional outstanding features as bonus!

8 References 1. retrieved on , 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 FDA. 6. Lilliam Rosario. FDA Data Standards: An Update; Drug Information association, November An Introduction to Structured Product Labeling, Aug 2009, Product Development Company 8. ICH-HL7 Regulated Product Submissions. GlobalSubmit. com Ann Neuer (June 22, 2009). Will Regulated Product Submission (RPS) Trump ectd?. Bio-IT World. com/news/2009/06/23/rps-trumps-ectd.html. 10. RCRIM Project Proposal Regulated Product Submission. hl7. org. May HL7 Regulated Product Submissions Goals and Scope. hl7. org. 21 April 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, Why Do I Need an Interface Engine? corepointhealth.

9 About 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.

10 10 ABOUT HCL HCL Technologies HCL Technologies is a leading global IT services company, working with clients in the areas that impact and redefine the core of their businesses. Since its inception into the global landscape after its IPO in 1999, HCL focuses on transformational outsourcing, underlined by innovation and value creation, and offers integrated portfolio of services including software-led IT solutions, remote infrastructure management, engineering and R&D services and BPO. HCL leverages its extensive global offshore infrastructure and network of offices in 29 countries to provide holistic, multiservice delivery in key industry verticals including Financial Services, Manufacturing, Consumer Services, Public Services and Healthcare. HCL takes pride in its philosophy of Employees First which empowers our 70,218 transformers to create a real value for the customers. HCL Technologies, along with its subsidiaries, had consolidated revenues of US$ 2.9 billion (Rs. 13,145 crores), as on 30th September 2010 (on LTMbasis). About HCL Enterprise HCL is a $5.5 billion leading global technology and IT enterprise comprising two companies listed in India - HCL Technologies and HCL Infosystems. Founded in 1976, HCL is one of India s original IT garage start-ups. A pioneer of modern computing, HCL is a global transformational enterprise today. Its range of offerings includes 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 diverse nationalities, who operate from 29 countries including over 500 points of presence in India. HCL has partnerships with several leading Global 1000 firms, including leading IT and technology firms. For more information, please visit