Compliance Management

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Compliance Management

• November 17th, 2005

Life Science Documentation
Klavs EsbjergHead of Department, Life Science
2
Claim 1

• The Requirement of cost-effective implementation
  of IT systems to the Life Science industry make
  the use of standard platforms and standard
  systems evident
• Proven technology is desirable as opposed to
  bespoke solutions
• Validation burden may be decreased
• Risk based validation approach can be applied

3
Claim 2

• However, use of standard systems and platforms
  require specific Life Science enhancements in
  order to
• Take full advantage of a decreased validation
  strategy
• Support Life Science Specific processes
• Stay tuned on regulatory updates
• Stay tuned on evolution of industry specific
  standards

4
Presentation Objectives

• WM-data Story Telling
• Overview of the challenges for the industry
  related to documentation and overall compliance
• Consider standard systems versus architecture
  systems in the document management / content
  management arena
• Present an example (Qumas) of a standard platform
  for solution of documentation / compliance
  problems

5
Presentation Overview

• WM-data in Life Science
• Documentation Challenges - Life Science
• Compliance Considerations What is it?
• CM and DM in the Market
• The Qumas Enterprise Solution

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The WM-data Group

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• Among the largest suppliers of IT-related
  services in the Nordic region
• Successful in the IT industry since 1969
• Listed on Stockholm Stock Exchange
• Strong financial background Investor AB (The
  Wallenberg Group)
• Industry oriented focus

• Group sales 20048.160 MSEK
• 9.000 employees
• 140 offices in the Nordic region

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IDC 2004 and 2005



2004
2005
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Strategic partnership

• Microsoft Gold Partner
• 2000 Microsoft consultants Nordic
• Axapta partner of the year
• 1st certified Axapta P partner

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WM-data Life Science

• 25 years of experience with the industry
• Strong relations to the customers
• Delivery of focused solutions
• Turn-key compliance solutions
• Solutions based on market leading technology
• Center for WM-data L-S activities is Denmark

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Selected References



11
Go-to-market



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Current Challenges



Validation

• In the Life Science Market
• Cost
• Image
• Price Control
• Innovation
• Regulations/Compliance
• Life Cycle Management
• Time to Market

EDC
Clinical DW
HL7
CDISK
eCTD
Risk Based
21CFR11
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Some Current IT Challenges

• Huge Amounts of data data availability
• Research/Clinical Data in Diverse Systems
• Huge Amounts of Documentation
• QA System
• Production Records
• Documentation to support Submissions
• Support of Compliance

Content Management / Document Management
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What is Compliance?

• Documented evidence of control
• Documented Business Process Control
• Procedures and Policies
• Computer System Validation
• GMP Great Mass of Paper
• GLP Great Lot of Paper
• GCP Good and Competent People?

Content Management / Document Management
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Standard Systems



Validation

• Life Science Enhancements key
• Reduce amount of validation Risk Based Approach
• Rely on vendor audits
• Use Vendor standard documentation
• Use Vendor standard validation/qualification
• Consistent Development
• Implementation of new regulatory requirements

EDC
Clinical DW
HL7
CDISK
eCTD
Risk Based
21CFR11
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DMS/CM in Market

• Architecture Solutions
• Industry Specific Middleware
• Standard Combination Products
• Publishing and Submission Management Tools

Technology content management tools are becoming
a key part of strategic projects due to
Information Management, Time to Market, Future
strategy towards e.g. eSubmission
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(No Transcript)
18
Qumas Positioning



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Qumas

• Flexibility towards future regulatory
  requirements
• Ability to accomodate the organizations processes
  and policies
• Standard product configurable
• Integration with legacy systems and submission
  tools
• Enhanced ability to search and retrieve
  information
• Total Cost of Ownership

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Qumas Compliance

• Advantages of centralized compliance
  documentation
• Design and document policies and controls in
  specific business areas
• Automate compliance processes
• Ensure and certify accuracy of information
• Identify and resolve exceptions to compliance
• Establish and follow procedures also P11
• Long term protection of information

21


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Features and Benefits

• 21 CFR Part 11 Compliance
• Complete Document Lifecycle Management
• Consistent Approach to Regulatory Compliance
• Support for Multiple Platforms
• Rapid Deployment and Validation
• Scalability
• Controlled Printing and Watermarking
• Extensive Reporting Capabilities
• Advanced Search and Retrieval

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Case II Axapta LS

• Features and Benefits
• Pre-validated documentation
• Increased control of processes
• Electronic Signature
• Specific Life Science modules
• Central GxP Enhancements

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Summary

• The Requirement of cost-effective implementation
  of IT systems to the Life Science industry make
  the use of standard platforms and standard
  systems evident
• Use of standard systems and platforms require
  specific Life Science enhancements in order to
• Take full advantage of a decreased validation
  strategy
• Support Life Science Specific processes
• Stay tuned on regulatory updates
• Stay tuned on evolution of industry specific
  standards

25
Questions

• ..alternatively

Klavs Esbjerg, M.Sc. Chem. Eng. Head of
Department WM-data Danmark A/S Lautrupvang 10 DK
- 2750 Ballerup Denmark www.wmdata.dk
45 44 78 40 00 45 44 83 83 98 45 44 78 40
01 45 21 71 73 60 klesj_at_wmdata.com
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