Let’s Innovate for Life
RIMS–ERP Integration
Possibilities and Benefits
Mallika Rajasekaran
Associate Director
Product Management
March 20, 2014
ArisGlobal Confidential
1
©2014 ArisGlobal. All rights reserved.
Agenda
Let’s Innovate for Life
• Why integrate RIMS and ERP systems
• Integration challenges
• What to keep in mind while integrating
• Conclusions
ArisGlobal Confidential
2
©2014 ArisGlobal. All rights reserved.
Challenges for Medicinal Product Industry
Let’s Innovate for Life
1. Monitor and report on safety and health regulation compliance
2. Ensure quality and traceability of raw materials and manufactured products
3. Manage the storage and retrieval of compliance documentation and certification
4. Manage product life cycles
5. Service complex markets
6. Improve time-to-market and streamline business processes
7. Comply with regulations
8. Improve electronic collaboration with customers and partners in the supply chain, while ensuring data security
9. Reduce costs of production and distribution
10. Innovate - develop new products to remain profitable and competitive
11. Manage seasonal demand
12. Manage product promotions and complex pricing
13. Account for royalties and licensing fees
14. Ensure quality and traceability of work in progress from subcontract manufacturers
15. Ensure efficient warehouse management and order picking and packing operations
16. Manage product and raw material shelf life
17. Manage customer relationships
18. Reduce risk of and manage product recalls
19. Plan and manage distribution and goods in transit
20. Manage complex and highly variable pricing and discount structures in international markets
21. Protect intellectual property
22. Minimise cost of development cycle
23. Maximise material yields
24. Manage different units of measure for all levels of the product recipes
25. Control product recipe changes
26. Accommodate and manage dynamic production plans
27. Ensure a high degree of formula precision
28. Constantly monitor and analyse product and customer activity
29. Integrate shop floor control and quality systems with business systems
30. Plan and manage capacity
31. Manufacture and Label as per the approved process and specification
1. Manufacture and Label according to approved process and specification
2. Manage the storage and retrieval of compliance documentation and certification
3. Manage product life cycles (PLM)
4. Manage product and raw material shelf life
5. Reduce risk of and manage product recalls
6. Plan and manage distribution and goods in transit
7. Control product changes like - recipe changes , labeling changes and so on
8. Quarantining finished goods based on Change implementation plan
9. Track and full fill Commitments
ArisGlobal Confidential
3
©2014 ArisGlobal. All rights reserved.
Business Requirements
Let’s Innovate for Life
1.
Reduce Time-to-Market for product launches
for better ROI
2.
Full regulatory compliance always
3.
Minimizing information gap between
i.
tracking of all regulatory events in
different regions and/or countries
and
ii.
keeping manufacturing departments
updated on regulatory developments
and requirements
ArisGlobal Confidential
4
©2014 ArisGlobal. All rights reserved.
Regulatory Data Requirements
-
Let’s Innovate for Life
Much more product information required than ever before
-
Regulatory Affairs teams can’t store / process it alone
-
It resides in silos of which Manufacturing is one
-
Upcoming standards – FDA-UDI, ISO IDMP, XEVMPD etc.
Manufacturing
Additional
Clinical
Particulars
Packaged
Medicinal
Product
Identifiers
like PhPID,
PCID, BAID,
MPID
Collaboration and Integration are the keys to success.
ArisGlobal Confidential
5
©2014 ArisGlobal. All rights reserved.
Let’s Innovate for Life
Regulatory
Manufacturing
Can they work in silos?
• Manufacture
• Ensure Quality
• Label
• Store
• Distribute
• Maintain
Documentations
• Maintain information in
ERP
• Submission Tracking
• License Approval
• Variation Approval
• Periodic Report
Submission
• Commitment Tracking
• Maintain Regulatory
submission and tracking
information in RIMS
Answer is: NO.
ArisGlobal Confidential
6
©2014 ArisGlobal. All rights reserved.
They should talk and they should talk often
RIMS
Let’s Innovate for Life
ERP
On
- Application Submission/Approval/Rejection
- Variation Submission/Approval/Rejection
- Approval Expectation
- Commitment made to authority
- Periodic Report planning and submission
- Queries from Authorities
- Safety incident on Field
- Product Recalls
ArisGlobal Confidential
7
©2014 ArisGlobal. All rights reserved.
How can they talk?
Let’s Innovate for Life
•
RIMS manages information about regulatory approvals, marketing authorisations,
and interactions with regulatory authorities
•
ERP manages complex supply chain, manufacturing processes, marketing and
distribution information.
Integrate ERP and RIMS so that information flows from one application to other
ArisGlobal Confidential
8
©2014 ArisGlobal. All rights reserved.
Example
Let’s Innovate for Life
Displaying expected approval dates; registration approval details the
ERP application from RIMS would be very useful in production planning.
The below example explains displaying Regulatory info in ERP
application.
ArisGlobal Confidential
9
©2014 ArisGlobal. All rights reserved.
Example
Let’s Innovate for Life
Similar examples of making regulatory data available in ERP
ERP Application
•Summary
•Registration Status
•Labeling Information
RIMS Web Services
•Pending Variations
Product
Country
ArisGlobal Confidential
10
Product: Advil
Country
Reg. Status
©2014 ArisGlobal. All rights reserved.
Date
Example
Let’s Innovate for Life
Look Up to ERP from RIMS
RIMS- Product-Formulation
Material Number Look up to ERP
Material # %MK98%
ERP
Material Name
Select
ArisGlobal Confidential
11
Material #
Material Name
MK9878-009
FOR-BRUFEN
MK9878-010
COT-BRUFEN
MK9878-089
PRE-BRUFEN
©2014 ArisGlobal. All rights reserved.
Possible Solution
RIMS- Product-Formulation
Let’s Innovate for Life
Material Number Look up to ERP
Material # %MK98%
Material Name
Select
•
This is recommended to get data in real time
•
Demands robust infrastructure
Material #
MK9878-009
Material Name
FOR-BRUFEN
MK9878-010
COT-BRUFEN
MK9878-089
PRE-BRUFEN
Use ERP Web Services
or other messaging
services to get data in
real time
ERP
ArisGlobal Confidential
12
©2014 ArisGlobal. All rights reserved.
Possible Solution
RIMS- Product-Formulation
Let’s Innovate for Life
Material Number Look up to ERP
Material # %MK98%
Material Name
Select
Material #
MK9878-009
Material Name
FOR-BRUFEN
MK9878-010
COT-BRUFEN
MK9878-089
PRE-BRUFEN
ERP
RIMS DB
Use scheduler to
synch the required
ERP data with RIMS
This is recommended to synchronize master data and codes
ArisGlobal Confidential
13
©2014 ArisGlobal. All rights reserved.
Agenda
Let’s Innovate for Life
• Why integrate RIMS and ERP systems
• Integration challenges
• What to keep in mind while integrating
• Conclusions
ArisGlobal Confidential
14
©2014 ArisGlobal. All rights reserved.
Regulatory Factors Affecting Time-to-Market
•
Expanding product portfolios and markets
•
Lengthy submission and approval processes
•
Varied timelines in different regions and countries
•
Different regulations in different country/region
ArisGlobal Confidential
15
Let’s Innovate for Life
©2014 ArisGlobal. All rights reserved.
Regulatory Factors Affecting Time-to-Market
•
Partnership with other vendors
•
Acquisition and Mergers
•
Varied ERP and RIMS systems with the organization
•
Varied Business Process within the organization
ArisGlobal Confidential
16
Let’s Innovate for Life
©2014 ArisGlobal. All rights reserved.
Agenda
Let’s Innovate for Life
• Why integrate RIMS and ERP systems
• Integration challenges
• What to keep in mind while integrating
• Conclusions
ArisGlobal Confidential
17
©2014 ArisGlobal. All rights reserved.
RIMS–ERP: Parameters to Synchronize
ArisGlobal Confidential
18
Let’s Innovate for Life
©2014 ArisGlobal. All rights reserved.
Identify Entities and Harmonize Vocabulary
Let’s Innovate for Life
Must Have
•
•
•
What is a Product in ERP and RIMS?
−
Is the Formulation or Recipe?
−
Is the final packaged product?
Common Terminology and Vocabulary
−
Dosage Forms
−
Packaging Types
−
Manufacturing Sites and their Roles
Understand coding and numbering scheme of
each system
•
Identify which entities matters the most for the
Integration
−
Do we need to track the ERP code of the substance
or tracking at formulation/Recipe is enough?
ArisGlobal Confidential
19
©2014 ArisGlobal. All rights reserved.
Identify What Manufacturing Needs from Regulatory
Let’s Innovate for Life
Manufacturing teams need to know the following
aspects from Regulatory Affairs:
1. Which products, formulations, and primary / secondary
packaging need to be made?
2. What are the specifications?
3. What needs to be visible on the label?
4. Are there any local deviations from the original dossier?
5. Which batch can be released to which country?
6. Can a batch be re-used in a different area?
ArisGlobal Confidential
20
©2014 ArisGlobal. All rights reserved.
Identify what Regulatory Needs from Manufacturing
Let’s Innovate for Life
Regulatory Affairs teams need to know the following
from Manufacturing teams:
1. Is the Change implemented?
2. When was the first Batch Dispatched?
3. Is there any change which requires Regulatory assessment?
4. Which Batch number was used in the Clinical Study?
5. Is the Stability Report Ready?
6. Is the Batch which was recalled in destroyed?
7. Are old stock Quarantined since the new specifications are
approved?
ArisGlobal Confidential
21
©2014 ArisGlobal. All rights reserved.
Identify Scope of the Integration Project
Let’s Innovate for Life
What is the objective and expectation of the integration
should be clearly identified
•
•
•
Who owns what?
−
Approval Date – RIMS
−
Batch Number – ERP
−
Formulation Number – ERP
−
Registration Number – RIMS
How long can you wait?
−
Do you need the data close to real time?
−
Or Nightly transfer of data would work?
Which are the events which would trigger data exchange
between ERP and RIMS?
−
Approval Obtained
−
Registration Withdrawn
ArisGlobal Confidential
22
©2014 ArisGlobal. All rights reserved.
Identify Scope of the Integration Project
•
Understand each regions practices
−
•
Let’s Innovate for Life
Listen to all and adopt the best practices
Define the level of automation
−
Can a flag be set in ERP automatically to start/stop the
production if a variation application is approved/rejected by
the authority and recorded in RIMS?
−
When a change is implemented and closed in ERP, should
the implementation date information be automatically
updated in RIMS?
•
Plan the Integration project in phases
−
Divide the project into achievable small milestones
−
Win the confidence of the users at each milestone
−
Success rate improves with phased approach
ArisGlobal Confidential
23
©2014 ArisGlobal. All rights reserved.
Agenda
Let’s Innovate for Life
• Why integrate RIMS and ERP systems
• Integration challenges
• What to keep in mind while integrating
• Conclusions
ArisGlobal Confidential
24
©2014 ArisGlobal. All rights reserved.
Conclusions
•
Let’s Innovate for Life
Benefits For Regulatory and Manufacturing Teams:
1. Improve information sharing
2. Minimize compliance gap between these teams through periodic reconciliation
of data
3. Avoid recalls by ensuring only approved and compliant medical products are sold
in country / region
4. Improve productivity via easy and quick access to information helping accurate
and proactive planning
•
Benefits For Top Management:
Linked records between RIMS and ERP based on each Regulatory event throughout
product life cycles, enable extended and detailed impact analyses for better
strategic planning
ArisGlobal Confidential
25
©2014 ArisGlobal. All rights reserved.
Copyright Policy
Let’s Innovate for Life
Copyright 2014 by ArisGlobal. All rights reserved. ARISg, agXchange, agSignals, agComposer, agNotify, agEncoder, Register, agClinical, agClinical
NW, agCapture and the @ris global® logo are trademarks or registered trademarks of ArisGlobal in the US Patent and Trademark Office and
other jurisdictions. Other marks may be trademarks or registered trademarks of their respective owners.
The information you see, hear or read on the pages within this presentation, as well as the presentation’s form and substance, are subject to
copyright protection. In no event, may you use, distribute, copy, reproduce, modify, distort, or transmit the information or any of its elements,
such as text, images or concepts, without the prior written permission of ArisGlobal. Trademarks, service marks, and logos (collectively the
“trademarks”) displayed on the pages within this booklet, are the property of their respective owner. No license or right pertaining to any of
these trademarks shall be granted without the written permission of Aris Global (and any of its global offices and/or affiliates, including
ArisGlobal UK Ltd., ArisGlobal GmbH, ArisGlobal KK). ArisGlobal reserves the right to legally enforce any infringement of its intellectual
property, copyright and trademark rights.
ArisGlobal Confidential
26
©2014 ArisGlobal. All rights reserved.
Let’s Innovate for Life
Lets’ Innovate for Life
ArisGlobal Confidential
27
©2014 ArisGlobal. All rights reserved.