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Automation Of Pharma Regulatory Compliances In HL7 Environment

Automation Of Pharma Regulatory Compliances In HL7 Environment

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. 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.

Excerpts from the Paper

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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