http://www.hcltech.com/healthcare/overview~ More on Healthcare 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.

1. January 2011
AUTOMATION OF PHARMA
REGULATORY COMPLIANCES
IN HL7 ENVIRONMENT

2. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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.
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

3. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

4. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
The following schematic diagram (Figure A) shows an interface
between the Pharmaceutical organization and the regulatory body
through a HL7 interface engine (HL7MIDW).
Pharmaceutical Regulatory
Organisation
HL7MIDW 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).
HL7 version A
LIMS1
HL7 version B
LIMS2 HL7MIDW FDA
XYZ Messaging
ERP/CDMS/HIS 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.
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

5. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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:
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 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
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

6. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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 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 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.
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

7. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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!
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

8. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
References
1. 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 2009
7. An Introduction to Structured Product Labeling, Aug 2009,
Product Development Company
8. “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 2006
12.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, 2010
14.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. AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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.
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.

10. 10
AUTOMATION OF PHARMA REGULATORY COMPLAIANCES IN HL7 ENVIRONMENT | January 2011
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 RD services and
BPO. HCL leverages its extensive global offshore infrastructure
and network of offices in 29 countries to provide holistic, multi-
service 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 www.hcl.in.
© 2011, HCL Technologies. Reproduction Prohibited. This document is protected under Copyright by the Author, all rights reserved.