1. DEPARTMENT OF HEALTH Medicines Regulatory Affairs
Date
DEPARTMENT OF HEALTH
Medicines Regulatory Affairs
(Pharmaceutical & Related Product Regulation & Management)
EDMS Workflow Specification and Software Configuration Project Update
E Taute SAPRAA 21 Nov 2008
The EDMS Workflow Specification and Software Configuration Contract is the biggest and core activity for the MRA EDMS project.
The MRA EDMS Project consists of 16 activities forming a logical and coherent transition from a paper based business model to an electronic based business model.
This is an update of the EDMS Project and more specifically the Workflow Specification and Software Configuration contract.

2. Date
The logical sequence of events for transition is based on 8 major milestones.
The workflow and configuration contract forms milestone or step number 4-7 of this sequence.
Eleven other activities combine with this contract to give the final end result of an electronic business system.
The periferal activities marked in the non-connected boxes impact on the logical steps as marked in each box.
The timelines for the steps 4-7 are as follows: (next slide)

3. EDMS Workflow Specification and Software Configuration Timeline
Date
EDMS Workflow & Configuration Project
EDMS Workflow Specification and Software Configuration Timeline
Project Phases (Deliverable)
Date
Phase 1 – Assessment
May 2008
Phase 2 – Design To-Be Environment
July 2008
Phase 3 – Configuration
November 2008
Phase 4 – Testing
February 2009
Phase 5 – Implement/Operate
May 2009
The EU Funding requires closure of all the contracts by 31 May 2009 and therefore the timelines are set to be completed by the same date.
Thereafter the configuration of all the software follows to simulate the final electronic business model for the MRA.
The internal testing and pilot verification will follow the configuration phase to ensure that the electronic model functions adequately and that all operations can be implemented.
It is expected that the deployment of the system to industry will be implemented during March, April and May of 2009.

4. Date
EDMS Workflow & Configuration Project
It is expected that the EDMS Project will provide the following within the scope of the configuration contract :
Conformance to local regulatory requirements
Ability to perform search and retrieval operations on the information stored in the system
Ability to perform workflow management in-house
Provide web-enabled centralised control
Conform to international regulatory standards
Conform to Government IT standards
Provide necessary tools to perform publication of updated information on website
Provide ability to maintain security/control via digital signatures
Ability to deliver version and iteration control
Provide a clear archiving strategy; and
Accommodate paper-based submissions
The EDMS Project is expected to provide the MRA with major advantages in document and information management such as:
High performance search and retrieval
Flexibility to change workflow configuration in house
Conform to Government and International IT and Regulatory Standards
Automated publishing of public domain information
High security environment
Sophisticated change management and archiving capabilities

5. Current and Future Commitments
Date
EDMS Workflow & Configuration Project
Current and Future Commitments
Workflow Configuration
Document Configuration
Scanning Capacity
Training
Information Management
Data Management
Change Management
Human Resource Capacity Building
The MRA is therefore entering a new phase in its operational lifespan with a well coordinated and investigated state-of-the-art electronic system.
In order to sustain this new system, the MRA is committing to various new operational and support functions such as:
- Workflow and document configuration
- Organisational and document change management
- Extensive training and human resource capacity building
- Data and information management leading to total knowledge management

6. Major Indicators International agency implementation & harmonization
Date
EDMS Workflow & Configuration Project
Major Indicators
International agency implementation & harmonization
Local Industry acceptance with provisos
- security, compatibility, capacity
Electronic process will satisfy environmental & archiving concerns
Data integration
Business Process Management (Standardisation and time-line control)
Knowledge Management (Management reporting, supervision and efficiency)
Format cross indexing (MBR1  MRF1  eCTD)
Capacity building
The major indicators for the MRA are centered around:
International and especially SADC harmonisation and implementation
Local industry cooperation
Publication of public domain information
Standardised data and information management
Flexible data and process integration
Capacity building and sustainable environmental protection
National archiving

8. MRA Network Topology Date
The MRA EDMS will be supported with a small secure local area network (LAN) as well as a wide area network (WAN) with a web enabled centralised control from the server.
This means that all users are registered on the system against a “username” and “password” and can access the system from anywhere through an internet connection.
The access rules will conform with the International regulatory requirements of the International Committee on Harmonisation, the USA Federal Drug Administration, the European Medicine Evaluation Agency and the South African Government Standards.
The system design also provides for the possible integration of video conferencing and thus recording of audio and video proceedings.

9. Successes and Milestones
Date
EDMS Workflow & Configuration Project
Delays and Problems
EU Funding
Delay in award of contract and eventual sign-off
Software funded by DoH
Specialists for testing (implementation support) – Appointment not approved
Data capturers not yet optimally utilised
Server security
Amendment Bill
Successes and Milestones
Windchill in Licensing up and running
Hardware Audit Completed
As-Is Process Maps completed
To-be Process Maps completed
Commenced with configuration
Major change in registration process – GMP approval up front
Slide 9 9

10. EDMS Workflow & Configuration Project
CTD / eCTD
Why?
Harmonisation
To provide for a common format/template for the submission of information to the regulatory authorities in the 3 ICH regions + South Africa
“Common Technical Document” signed-off by ICH in November 2000
Advantages / Objectives:
Resource saving for industry
Facilitate simultaneous submission in all the regions
Facilitate exchange of regulatory information
Harmonised format to be further supported by the eCTD
More efficient assessment, e.g. use of hyperlinks
Faster availability of new medicines

11. EDMS Workflow & Configuration Project
CTD / eCTD
However, CTD is only a FORMAT !
It’s not a “single” dossier, with a “single” content since
Legal requirements differ in the regions
ICH guidelines have not yet harmonised all requirements
SA guidelines not all harmonised
Pharmacopoeiae are not harmonised

12. EDMS Workflow & Configuration Project
Module 1:
Not Part of the CTD Content to be determined by authorities
Module 1
Regional Information
1.0
CTD Table of Contents
2.1
CTD Introduction
2.2
Module 2
Module 2
Module 2
Non-clinical
Overview
2.4
Clinical
Overview
2.5
Quality
Overall
Summary
2.3
Module CTD
Non-clinical
Summaries
2.6
Clinical
Summary
2.7
Module 3
Quality
3.0
Module 4
Non-clinical
Study Reports
4.0
Module 5
Clinical
Study Reports
5.0
Modules 3 - 5 12

13. Heart of Dossier
MRF1
PART 2 Basis for Registration and Overview of Application
PART 2A Pharmaceutical and biological availability
PART 2B SBRA
PART 2C Pharmaceutical Expert Report
PART2D Pre-Clinical Expert Report
PART 2E Clinical Expert Report
CTD
Module 2
Section 2.3 Quality Overall Summary
Section 2.4 Nonclincial Overview
Section 2.6 Nonclinical Written and Tabulated Summaries
Section 2.5 Clinical Overview
Section 2.7 Clinical Summary

14. Technical “part” of Dossier
CTD
Module 3
3.2.S Drug substance
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
3.2.S.4 Control of Drug Substance
3.2.P.4 Control of Excipients
3.2.P.7 Container Closure System
3.2.P.3 Manufacture
3.2.P.5 Control of Drug Product
3.2.P.8 Stability
3.2.P.2 Pharmaceutical Development
MRF1
PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient (API)
PART 3B: Formulation
PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients
PART 3D: Container & Packaging Materials
PART 3E: Manufacturing Procedure
PART 3F: Final product Specifications & Control
PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)
PART 3H: Pharmaceutical Development
PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine

15. Technical “part” of Dossier
MRF1
PART 3 Pharmaceutical & Analytical
PART 3A: Active Pharmaceutical Ingredient (API)
PART 3B: Formulation
PART 3C: Specifications & Control Procedures for Pharmaceutical Ingredients
PART 3D: Container & Packaging Materials
PART 3E: Manufacturing Procedure
PART 3F: Final product Specifications & Control
PART 3G: Stability Data of the Finished Pharmaceutical Product (FPP)
PART 3H: Pharmaceutical Development
PART 3I: Expertise and premises used for the Manufacture of a Biological Medicine
CTD
Module 3
3.2.S Drug substance
3.2.S.4 Control of Drug Substance
3.2.P Drug Product
3.2.P.1 Description and composition of the drug
3.2.P.2 Pharmaceutical Development
3.2.P.3 Manufacture
3.2.P.4 Control of Excipients
3.2.P.5 Control of Drug Product
3.2.P.6 Reference Standards or Materials
3.2.P.7 Container Closure System
3.2.P.8 Stability
3.3 References

16. EDMS Workflow & Configuration Project
CTD/eCTD Challenges
EU eCTD vs MRF1 vs SA eCTD
Module 1 PART1
Screening
BE data + dissolution data
Reference products
Module 3 “Body of Data”
On-line submission / CD / DVD
Paper submissions
Paradigm shift