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HCL Technologies

Automation of Pharma Regulatory Complaiances in HL7 Environment

Automation of Pharma Regulatory Complaiances in HL7 Environment

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.


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