Electronic Data Management In Pharmaceutical Industries

Published Date: 02 Nov 2017

Abstract

The Pharmaceutical industries are in a highly regulated environment, it requires effective document management processes. In addition to the strict regulatory environment, the Pharmaceutical companies must find ways of dealing with the increasing amount of information that must be processed. Having timely accurate data is critical for the success of any company. Data has never been easy to manage, and is especially true in pharmaceutical industry. Along with the documentation management, the security of data is also crucial. Note that electronic information includes everything such as emails, adverse event reports, complaints, batch records, quality control records – everything that is stored electronically. A document management system is designed to automate a business process. In its simplest form, this involves capturing of paper documents so that an end user can retrieve the image of paper document from their computer. Several technologies are being used currently in pharmaceutical industry to manage their huge volumes of data generated on daily basis. Some of the latest technologies are discussed in this review article along with their advantages and disadvantages.

Key words: Document management, electronic records, Technology

Introduction

Data has never been easy to manage, and is especially true in pharmaceutical industry. Along with the documentation management, the security of data is also crucial. If you think that pharmaceutical companies are not at risk, think again. Assume the worst case when it comes to security and integrity of data. Data integrity is essential to regulatory compliance and the fundamental reason for 21 CFR Part 11. The FDA uses the acronym ALCOA to define its expectations of electronic data.

Attribute

Long - lasting

Contemporaneous

Original Accurate

According to 21 CFR Part 11 the electronic records and electronic signatures must control the electronic data record security, integrity, traceability and the proper use of electronic signatures.

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Figure no 01: Document management system

A1 document management system consists of hardware and software that converts paper documents into electronic documents, manages and archives those electronic documents and then indexes and stores them according to company policy. Following are some of the technologies used in electronic data management in pharmaceutical industry.

Laboratory information management systems LIMS 2

It is a software based laboratory and information management system that offers a set of key features that helps supporting modern laboratory’s operations. Key features of LIMS include workflow, data tracking, data exchange interface, assay data management, data mining, data analysis, electronic laboratory notebook (ELN) integration etc. Though LIMS is commercially available since 20 years but now many changes have happened according to today’s needs.

LIMS holds information about samples in a laboratory, but which information is stored varies a lot between different user organizations. Some laboratories only store information about end results of the analysis. Others utilize the complete LIMS where all instruments are connected to the LIMS, all data is transferred electronically between the instrument and the LIMS. Different industries have different needs for functionality.

A QC laboratory in a production plant will need to include specifications to make sure the sample results are within specifications.

A pharmaceutical R&D laboratory may need to include stability testing data and pharmacokinetic testing.

SAMPLE IDENTIFICATION

Sample type, sample source, sample date, priority.

All this information is entered in to the LIMS database either by manually or by electronically

SAMPLE LOGIN

Date and time of sample received

7. LABORATORY MANAGEMENT

Work scheduling

Completed analysis

Incomplete work

Workload demands

Protocol maintenance

Cost allocation

RESULTS CREATION

PROGRESS TRACKING

Work process tracking and sample location tracking

INSTRUMENT INTEGRATION

Instrument interfacing

Data acquisition

Instrument control

8. SYSTEM MANAGEMENT

Security

Data archive

Data retrieval

REPORTING

Results reporting

results redistribution

report definition

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Figure no: 03 Functional model of LIMS

Advantages of LIMS

Makes ergonomical for individuals working in laboratory

Reduction in ambiguity and improvement in consistency of laboratory practices with effective implementation and documenting the same.

Increase in productivity occurs when the system is properly integrated in to the daily routine of laboratory operations.

All the information can be stored and retrieved from the central database

Real time control of data with built in QC specifications

Disadvantages of LIMS

Adequate validation to ensure data integrity

Limited interface between lab & field computers

Cost of LIMS

Electronic data capture (EDC) 4

It is a computer based system designed for collection of clinical data in electronic format. EDC has replaced the traditional paper – based data collection methodology to streamline the data collection and reduction in time to market drugs and medical devises. EDC systems are now being adopted by many pharmaceutical companies and clinical research organizations. EDC is originated from earlier software called as Remote Data Entry (RDE). Users of EDC are Sites (a place where clinical trial is being conducted), Sponsor (A company/ person who funds the clinical trial), CRO (contract research organization which facilitates planning and conduct of clinical trial). It is used in all phases of clinical trials to collect and manage the information.

Objectives for implementing an EDC system:

Real time data access

Efficient data transfer and faster impact on marketing a drug

Overcoming the shipping of paper CRFs (case report forms) from remote areas

Synergy between the serious adverse effect reporting and the data base

EDC in CLINICAL TRILAS

Figure no 04: EDC in clinical trials

Comparison between Paper Data Capture (PDC) and Electronic Data Capture (EDC) 5

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Figure no 06: Paper data capture in clinical trials

EDC Data Gathering model (CT — clinical trial, RC — research center, eCRF — electronic Case Report Form, iEDC — electronic data collection application)http://ars.els-cdn.com/content/image/1-s2.0-S1551714409000445-gr4.jpg

Figure no 07: EDC in clinical trial

PDC CT Management model and EDC model both are same but only difference in sub-processes like

Data gathering at each centre

Monitoring of trial

Management of data

EDC can increase savings when compared to PDC in terms of error and query rates, average efforts and staff price, data collection, transfer of information, streamline flow of clinical trial, reduced monitoring.

Advantages of EDC 6

Faster data transfer

Instant data access by the staff

Reduced queries

Data can be categorized and indexing is possible

Decision point can be reached more quickly, this will save both time and money

Disadvantages of EDC

Installation of software in each PC which is costlier

Availability of Internet connections in remote areas where trial is being conducted

Data security is a major problem if public internet is being used

Regular validation of electronic devices

Regulatory compliance

Share point document management system7

It is a web based application developed by Microsoft in 2001. Share point can be used to provide document and file management, intranet portal, enterprise search, business intelligence and it has unique features like system integration, process integration, and work flow automation capabilities. This application is being used by 78% of fortune 500 companies. Pharma companies invest a lot in documentation and content management, and now they are intrigued by possibilities in share point system.

Using share point document management system one can create document libraries where you can store/ share variety of files. Team members can access these files using their login ID’s and approved users can checkout and edit the files.

Applications of share point system

Intranet portal

It creates a centralized access to enterprise information within the organization. There by helps the company in employee management, process management.

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Figure no: 08 Share point document system portal service

Enterprise content and document management

Keeping track of electronic records and images

Digital record management

Compliance with regulatory requirement in terms of document keeping

Centralized location for storing the documents

Collaboration system

It provides a platform for exchange of data with any organization at any place in the world.

Figure no 09: Share point document system

Enterprise content management 8

The Association for Information and Image Management (AIIM) international, worldwide association for enterprise content management, defined the term Enterprise content management in the year 2000. Enterprise Content Management (ECM) is a software application with collection of different tools like capture, manage, store, preserve, and deliver content and documents related to organizational processes. ECM covers web content management, search, work flow management, capture and scanning, and it primarily aims at managing the life cycle of information from initial publication or creation all the way through archival and eventually disposal.

Components of ECM :

DM: document management, WCM: web content management, RM: record management,

BPM: business process management

Figure no 11: components of ECM

Capture

It contains the components for processing analogue and electronic information. Capture components are called as "input" components.

OCR (Optical Character Recognition), HCR (Handprint Character Recognition), ICR (Intelligent Character Recognition), OMR (Optical Mark Recognition),

Figure no 12: components of data "Capture" in ECM

Manage

Figure no 13: components of "Manage" in ECM

Collaboration

Simply called as "working together", Collaboration includes the following functions:

Database for joint information processing and Integration of information from other application. Communication application such as video conferencing is also possible with collaboration.

Web Content Management

It creates new content or edits the existing information in a controlled format and automatic conversion for various display formats.

Secure separation of access to public and non-public information

Document management

It includes functions like:

Checking the stored information for consistency, version management, search and navigation and visualizing of different files of different formats.

Record management (file and archive management)

Orderly storage of information, unambiguous indexing of information and management of record retention schedules and deletion schedules.

Business process management (BPM) / work flow

Production Work flow (work flow is guided by predefined sequence)

Work flow

Ad – Hoc Work flow (work flow is determined by the user)

Functions of work flow management include:

Imaging of process and organization structures and sequential processing of procedures with simultaneous saving.

Function of BPM includes:

Functionality of work flow

Process and data monitoring

EAI or Enterprise Application Integration, to link different applications

Store

It acts as a temporary storage of information.

Figure no 14: components of "Store" in ECM

Preserve

The preserve components of ECM handle the safe storage and backup of information which is not necessary to archive.

Figure no 15: Components of "Preserve" in ECM

Deliver

It helps in presenting the information from the other ECM components like "Manage", "Store", and "Preserve" components.

Share point system can be integrated with ECM for a better management system

Limitations of EMC 9

Collaboration is not effective when compared to the SharePoint system

Managing rules are limitation to the document process it needs integration with better rules engine

Some other systems like Enterprise Resource Planning (ERP), Ware House Management (WHP), Electronic notebooks, Content Management System (CMS), Library Information Control, and Enterprise Content Management (ECM) are some of the technology solutions available today for the electronic data management in the indus

Impact of Electronic documentation on Pharmaceutical industries 11

Pharmaceutical companies come across lot challenges relating to document control from the preclinical stage to post market stage.

Effective document management software provide an effective document control throughout the product development lifecycle by accelerating time to market and simplifying workflow, promoting efficiency, and makes the compliance easier.

Collaboration helps in exchange of views with any organization or person throughout the world.

Provide appropriate templates for regulatory submission making it easier for pharmaceutical companies

Tracking facility of the electronic management system helps in keeping track of all sorts of documents.

Usage of unapproved and obsolete documents can be prevented with document automation

Conclusion

According to a survey most of the companies spend 6% to 15% of its gross revenue in creating and management of documents. So, there is great need for effective document management and the solution is Electronic document management. Though some of the advantages are there for electronic document management like faster information circulation, stream line work flow etc. but it has got some of the limitations as well like ; computer system dependency, bureaucracy development, investment for software, regular validation of systems etc. on comparing all the pros and cons, the advantages overweigh disadvantages. And it is not possible to find another way to information management, without computer technology, without electronic document. But it is also necessary take into consideration all negatives and remembers about them.