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Veeva RIM

The document discusses how to get started with regulatory information management (RIM). It outlines a 5 step process to define the current and future states of RIM, develop a phased roadmap, and plan the first phase. The goal is to centralize regulatory data across systems to improve oversight and ensure continued compliance.

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109 views3 pages

Veeva RIM

The document discusses how to get started with regulatory information management (RIM). It outlines a 5 step process to define the current and future states of RIM, develop a phased roadmap, and plan the first phase. The goal is to centralize regulatory data across systems to improve oversight and ensure continued compliance.

Uploaded by

justsally
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Regulatory Information Management

Why and How to Get Started


Why and how to get started?

Why should we start looking at Regulatory Information Management (RIM)?


Historically, Regulatory information has been managed in a multitude of systems, file shares, as well as SharePoints and/or
intranet sites across the global, regional and local Regulatory organizations. As a consequence, getting a global overview of
key Regulatory information and data has been – and still is to a large extent – a significant industry challenge.

Combining this with: 1) the ever increasing complexity of regulations and product portfolios, 2) growing demand for data
due to increased public and regulatory scrutiny, 3) the trend of further global collaboration and standardization of formats
and processes across the regulators, and 4) increased use of partners and outsourcing, it becomes clear that:

The challenge of getting a global overview of key Regulatory information and data is only going to
01 grow, unless we start changing the way we work with and manage Regulatory information

Investing in robust, integrated Regulary systems utilizing the emerging standards will be key to
02 ensuring continued compliance and efficiency

At HighPoint we developed a 5 step process to help you get started on your RIM journey by:

• Understanding where you stand today with regards to Regulatory Information Management
• Defining where you want to go with regards to Regulatory Information Management
• Developing the plan for how to get there

01 02 03 04 05

Define Assess Current Define Future Develop Phased Develop Detailed


RIM State State RIM Roadmap Phase 1 Roadmap
Step 1 – Defining what RIM means to your organization
Regulatory Information Management (RIM) is a term that was born back in the mid-2000s and which has been developing
ever since. Essentially, RIM can be defined as the capability to support global regulatory activities. Meanwhile, this is not
very specific, operational or actionable. At HighPoint, we have therefore defined a RIM Framework based upon which a
client-specific RIM definition can be developed.

HighPoint RIM Framework

Step 2 – Defining your current state for phase 1


After defining a precise scope, the next step is to define and assess your current state with regards to people, process,
techonology and data through documentation review, structured Discovery interviews, workshops and ad-hoc interactions:

• People & Process: Global Regulatory organization structure, high-level roles and responsibilities, current business
processes, and current people and process related challenges.

•T
 echnology & Data: Systems (incl. Excel trackers and SharePoint sites) currently used to support Regulatory business
processes, data managed within systems, data flow between systems, and current technology and data challenges.

The current state assessment should produce the deliverables listed below:

1) As-is Global Regulatory organization structure, roles and responsibilities 3) As-is IT architecture and data flow

2) As-is business processes 4) Tangible challenges to be addressed


Step 3 – Defining your future state for phase 1
Based on your current state definition as well as Industry regulations and best practices, step 3 is to define your desired
future state through a combination of structured Discovery interviews, workshops and ad-hoc interactions:

• People & Process: Global Regulatory organization structure, high-level


roles and responsibilities, future business processes, and future people
and process specific improvements. Process

• Technology & Data: Systems to be used to support Regulatory business


processes, data to be managed within each system, data flow between
systems, and future technology and data related improvements. People IDMP Data

HighPoint recommends initiating the vendor selection process during this phase
by conducting a request for information to get inspiration from the market and to
make sure that the future state is “grounded” and can actually be implemented. Technology

The future state definition should contain the following deliverables:

1) Global Regulatory organization structure, roles and responsibilities, 2) to-be business processes, 3) to-be IT
architecture and data flow, 4) RIM User Requirements and Use Cases, and 5) tangible benefits to be delivered.

Step 4 – Defining a phased RIM roadmap


Once you have defined what RIM means to your organization, the next step is to look at that definition and break it down
in a phased roadmap with a clearly defined scope per phase. This roadmap can cover your full RIM definition in multiple
phases or it can consist of phase 1 with the the remaining phases to-be-determined if a long term RIM program isn’t
feasible in the current circumstances.

Step 5 – Defining the detailed phase 1 roadmap to bridge the gap


Once you have defined both your current and future states, the next logical step is to assess and define the gap between
the two as well as the solution and plan for bridging the gap. At HighPoint, we highly recommend continuing the vendor
selection process during this phase by conducting a request for proposal (RFP) to ensure robust and realistic resource and
cost estimation as well as planning.

The planning phase should deliver the following:

1) RIM Roadmap and Charter 2) RIM Project Business Case(s), and 3) High-Level Project Plan

Conclusion
For both historic and contempory reasons, the challenge of managing Regulatory information ensuring compliance and
efficiency is only going to grow. It necessitates us to change the way we work and start investing in robust, integrated
Regulary systems supported by robust data management and utilizing emerging standards and technology developments.

US: 301 E. Germantown Pike, East Norriton, PA 19401 | +1 800.238.1230


EU: Cours de Rive 13, CH-1204, Geneva, Switzerland | +41 0.22.735.95.81
www.highpointsolutions.com

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