IMPROVE YOUR SUPPLY CHAIN OVERSIGHT

Transcription

1 IMPROVE YOUR SUPPLY CHAIN OVERSIGHT Advantages of linking your ERP and RIMS data sets December 7, 2017

2 Introductions and objectives Sara Berdajs Confidential IPERION

3 Hostess Sara Berdajs Main Speaker Frits Stulp Topic Expert Duncan van Rijsbergen Consultant Sara has been working with IDMP since 2015 Successfully established processes, organisation and documentation to secure lifecycle maintenance of IDMP Iteration 1 data Managing Director & Owner >18 years experience in the Life Sciences Industry IRISS IDMP Topic Group Lead IDMP SME, program manager and trusted client program advisor Associate Director > 13 years experience in Regulatory Affairs CMC, clinical, product information, safety and administrative aspects Confidential IPERION

4 Objectives of today s webinar To introduce ERP-RIMS linking as a prime example of the need to cross organizational silos An example of IDMP and interoperability within the organization To show the business benefits of data interoperability through the example of ERP-RIMS linking To share the key steps to successfully linking ERP and RIMS Confidential IPERION

5 ERP-RIMS is the prime example for the need to cross organizational silos Frits Stulp Confidential IPERION

6 Increased complexity of business questions exceeds traditional silos and asks for data standardization ISO IDMP is the only globally agreed standard that covers the entire gamut of medicinal product data IDMP ISO IDMP compliant systems and processes: Work equally well as conventional ones Have the added value of consistency, quality and interoperability across the entire pharmaceutical business, inside and outside your company Confidential IPERION

7 Information Management Maturity The (growing) role of data in your organization Robust, standardised and consistent source of high quality data Point-to-point integration and automation Full integration and automation via MDM Quality & Consistency Efficiency High Performing Single source of structured product information of high quality and consistency Efficiency gains by a single point of data entry and exchange of structured product info between systems Data driven business via information integration across multiple functional platforms Time To achieve this, interoperability & cross silo working is essential! Confidential IPERION

8 RIMS and ERP are the main systems for two highly interconnected functions change control RIMS Regulatory Information Management System is where the Regulatory Affairs function maintains the authorized product data and the approval status of regulatory procedures ERP Enterprise Resource Planning is where the Operations function maintains the manufacturing data of products actually in production and the planning of the resources needed for the production and distribution of those products change control *Want to know more about RIMS? Click here to watch our RIMS webinar on Confidential IPERION

9 RIMS and ERP model the same real world process from different perspectives RIMS Contains product data to plan and control what is AUTHORIZED Approved Dossier Manufacturing Pharmaceutical Product Primary Package Packaged Product Product Release Wholesaler Pharmacist Patient Contains product data to plan and control what is PRODUCED ERP EMVS* Contains product information in line with what has been DISTRIBUTED *Future Confidential IPERION

10 In a regulated environment production and authorization are part of the same process? Need for Common language Aligned processes Ability to exchange data Work together to achieve common goals of operational excellence and compliance Confidential IPERION

11 The interdependencies between RA and OPS result in multiple use cases for ERP-RIMS linking Portfolio management Deletion non-marketed registrations & low profit/ high maintenance products Change control Quick & complete identification of SKUs affected by a (planned) regulatory change Artwork management Automatic communication of regulatory approvals to ERP and linked systems Compliance Quick identification of divergent data between ERP & RIMS Traceability Implementation of Falsified Medicines Directive Regulatory data submissions Facilitate full IDMP implementation Process efficiencies Minimize double entry Interoperability Exchange of information Confidential IPERION

12 Use case example 1: Portfolio Management Operations ERP actual production Regulatory RIMS authorized Confidential IPERION

13 Example 2: Change control Change Product impact Country impact Regulatory status Implementation progress Confidential IPERION

14 Linking your ERP and RIMS data sets Duncan van Rijsbergen Confidential IPERION

15 Product as the common factor between ERP and RIMS ERP and RIMS both contain representations of products The viewpoints on the product differ between the systems Different product aspects e.g. RIMS: authorizations e.g. ERP: stock keeping units Different attributes of the product e.g. RIMS: registration number e.g. ERP: article number Confidential IPERION

16 Comparing product representations between ERP and RIMS ERP and RIMS both assign attributes to, and relations between, product objects (e.g. dose form, packaging, pack size). These attributes can be: In common and the same = Similar, related not the same e.g applied storage e.g. dose form condition in ERP [15- =? 25 C] vs storage condition as authorized in RIMS [store in original packaging] Not in common, but relevant Not in common, not relevant e.g. artwork id in ERP e.g. registration status in RIMS?..! e.g. storage location in ERP e.g. international birth date in RIMS 3?.. x Confidential IPERION

17 Exchanging data through mapping products RIMS information exchange ERP product mapping RIMS product representation ERP product representation Complexities differences in product representation present challenges to mapping Confidential IPERION

18 Linking ERP and RIMS successfully should cover all aspects of Iperion s Interoperability model 1. Organization: Bring functions together and find a common vocabulary RIMS ERP Data model 2. Information: Determine the common product model and map products 3. Process: Align processes to maintain mapping over time and overcome complexities ERP 1111 RIMS 4. Technology: Find a suitable (non-)technical way to connect Confidential IPERION

19 1. Organization: bring functions together and find a common vocabulary ERP RIMS linking needs participation from both OPS and RA: Find a common vocabulary to describe products as a basis for mapping Learn about each other s processes to resolve mapping complexities Work together to drive the project and achieve success Involve Business Intelligence / IT : Understand the business needs that drive finding the right technology support Confidential IPERION

20 2. Information: Determine the common product model and map products Determine a common product model that allows to find the corresponding product object(s) in the target system based on the attributes of the product object in the source systems. Example product objects product set: active dosage form - strength packaged product: [product set] pack type pack size licensed product: [packaged product] marketing authorization manufactured product: [packaged product] manufacturer The choice of product objects depends on the desired use cases and the dimension of the product portfolio. Confidential IPERION

21 3. Process: Align ERP and RIMS procedures in a common change process Operational and regulatory procedures are part of a larger process Information exchange facilitates optimization of the common process Identify use cases and target information suited for exchange Can the change be found in both processes? Are change triggers and timing compatible? Do product objects change in a similar way? What is the consistency of objects over time? ERP Process versions versions RIMS Confidential IPERION

22 4. Technology: Find a suitable (non-)technical way to connect There are multiple ways to connect ERP and RIMS Choose technological solution based on product portfolio and use cases Beware of narrow point-to-point solutions: products and use cases change over time. Possible bridging strategies for ERP-RIMS Single bridge: Represent key to ERP data in RIMS or vice versa Multi-level bridge: Represent key to ERP/RIMS on various levels of the product hierarchy Data warehousing: Consolidate ERP and RIMS data in a datawarehouse Common product model: Define ERP and RIMS entities following a common product model in a third system Master Data Management: Include master data to refer to in ERP and RIMS Manual process based integration: Human extraction and merging of data Confidential IPERION

23 Our ERP-RIMS formula for interoperability RIMS ERP Data model ERP 1111 RIMS Bring OPS and RA together: Determine use cases Find the common product vocabulary Based on use cases and product vocabulary: determine the product model apply product model to RIMS and ERP data map the RIMS and ERP product data sets Align processes between OPS and RA in terms of triggers, timing and data handling: Consistency of product objects and stability of mapping over time Determine the right technological solution: maintain the mapping exchange the data for the use cases support future product portfolio and use case changes Confidential IPERION

24 Conclusion To address complex business challenges, companies need to escape functional silos in favour of supporting enterprise-wide end-to-end processes; interoperability is the key to this transition Linking ERP as the key system in OPS, and RIMS as the key system in RA, is a prime example of information exchange generating immediate business benefits ERP and RIMS can be linked through their common representation of products; to achieve a stable information exchange, RA and OPS need to work together with regard to organization, information, processes and technology Confidential IPERION

25 Update from our marketing team Sara Berdajs Confidential IPERION

26 Don t miss out on our next webinar! Structured Content Authoring Efficient document management Date: 16 January, 2018 Time: AM (CET) & 5-6 PM (CET) For more information visit our website at Confidential IPERION

27 Don t miss out on our webinar series! Upcoming webinar Dates & times will be announced soon! For more information visit our website at Confidential IPERION

28 Questions & Answers Frits Stulp Confidential IPERION

29 About Iperion Reading Material Confidential IPERION

30 Iperion is a life sciences consulting and pharma IT company, based in The Netherlands with a global focus IDMP RIM STRUCTURED AUTHORING QMS GXP CLOUD COMPUTING Readiness Assessment ISO IDMP Implementation Project Management IT Strategy and Information Architecture ISO IDMP Training Confidential IPERION

31 Why our clients chose Iperion? Standardized RIMS maturity assessment Rapid onboarding of relevant stakeholders Focus on key RIM processes Accelerators >>> Experienced data management professionals Guidance via our extensive networks Pragmatic, hands on & fit for purpose solutions Confidential IPERION

32 Our extended regulatory network keeps you informed on all latest developments EMA NEN / ISO FDA SPOR (IDMP) Taskforce CBG / MEB Industry Reps IDMP roundtable IRISS Your business Confidential IPERION

33 Want to know more? Quick scan: How can you address this topic? Object definition & mapping (assessment) Planning and Set Up (future state definition) Development & Implementation Kick off Work Session Work Session Close out HL Objects Definition Complications identification Use case definition Requirements definition Business case creation Solution definition Project plan & setup Solution Development Validation Process (re)design Data governance set up Change management Quality documents creation Training ERP alignment e.g.: Ensure data alignment/clean-up/enrichment RIMS alignment e.g.: Ensure data alignment/clean-up/enrichment We are helping several of our clients with this, so feel free to contact us to find out how we could support you Confidential IPERION

34 Thank you for your attention! IPERION Consultancy Cloud computing Information systems Guided by the slogan systems and services that work for life sciences, Iperion s team of skilled professionals is focused on the development, delivery and integration of systems and technology that help our life sciences clients to innovate and improve business processes and supply chains. Our clients are pharmaceutical, medical devices and biotech companies as well as organizations operating in the healthcare and regulatory sector. For more information about our organization, please visit iperion.nl IPERION All Rights Reserved. Contact information contact@iperion.nl Address Achterstraat CS Vlijmen The Netherlands Confidential IPERION