SharePoint vs RIM: When to migrate to a Compliant RIM System

Last Updated: October 2026

Are you a regulatory leader trying to meet tight submission deadlines with distributed teams and multiple vendors responsible for various content? You are not alone.  Many sponsors are wrestling with the same challenges. 

SharePoint or a RIM system: when should you migrate? Move to a purpose-built RIM system when regulatory work outgrows a general document library: typically when you approach your first IND or CTA, add vendors and co-authors, enter Phase 2, or can no longer show a validated, auditable record of who changed what. SharePoint can store documents, but validation, audit trail, submission structure, and health authority tracking are yours to build and qualify.

In this article

• What is a RIM system?
• Challenges with SharePoint for RIM
• When to migrate from SharePoint to a RIM system
• How a RIM system addresses these challenges
• What is the best RIM system for your organization?
• What migrating from SharePoint involves
• How the main RIM options compare
• How Kivo helps teams move off SharePoint
• Frequently asked questions

Often, we encounter emerging pharma teams at cross-roads in their growth. In the early stages (pre-IND and Phase 1), SharePoint is one of the most popular solutions for storing, collaborating, and maintaining regulatory documents. Although SharePoint is simple to start using and is low cost, it does not consider the unique needs of regulatory or the regulated industry in general.  And as clinical trials progress into Phase 2, SharePoint can start to break down. From version control issues to lost edits and more, using SharePoint as your central regulatory information repository can hinder your ability to meet submission deadlines. 

An alternative to SharePoint is a purpose- built Regulatory Information Management (RIM) System. In this article, we'll discuss what a RIM System is, why SharePoint is not the best fit for the regulatory industry, when to migrate, and finally, what to look for in a RIM Solution. 

What is a RIM System? 

Regulatory Information Management (RIM) covers many tasks, management functions and cross- functional touch points. Regulatory professionals oversee the process of getting a drug or product through governmental agency review and approval, such as FDA or EMA. They also must ensure that an organization's product abides by the regulatory standards outlined by the FDA or ICH.

RIM Systems typically include the following features and use cases:

1. Submission Forecasting and Resource Planning
2. Dossier Management (content plan, distribution, archive)
3. Submission and Electronic Document Management (EDMS)
4. Submission
5. Submission Planning and Tracking
6. Product Registration Management
7. Health Authority Commitment Management
8. Health Authority Interactions (Q&A, Correspondence)
9. Regulatory Archive
10. Label Management
11. Reporting, Analytics, Dashboard
12. Data Standards and Governance Management
13. Design History File (Medical Device)
14. Regulatory Intelligence

The number of documents required by these regulatory bodies can be staggering. In addition to the high volume of materials needed, there are extensive regulations outlining how documents need to be formatted, how changes to these documents must be recorded (the audit trail), and how they must be approved by various stakeholders.

A Regulatory Information Management (RIM) System is software designed to help manage the process for these clinical trial submissions. We could spend many blogs simply discussing the scope of RIM and defining the components. That said, every RIM System requires two critical functions: Submissions and Document Management.

SharePoint, despite being compliant with some of these guidelines, is not purposely designed for a highly regulated industry.

Challenges with SharePoint for Regulatory Information Management (RIM)

SharePoint is industry agnostic. It can be used for document storage, project management, for purchase requests, or even as an internal newsletter! But this flexibility means that it doesn't cater to any specific industry, organization or provide templated workflows. In a highly regulated industry such as pharmaceuticals, this can create many challenges and compliance issues. 

Here are 10 possible challenges you may encounter using SharePoint for Regulatory Information Management:

1. Validation is your responsibility. Microsoft states that no certification exists for complying with 21 CFR Part 11 and that customers must ensure their own applications meet FDA requirements, so you must qualify SharePoint for each regulated use. See Microsoft's Part 11 documentation and FDA’s 21 CFR Pt 11 Guidance for Electronic Records and Electronic Signatures.
2. Audit logging is not designed as a regulatory audit trail out of the box; you must configure, qualify, and review it yourself.
3. Collaboration sessions often fail, experiencing loss of data or edits while authoring and reviewing documents either for submissions or other regulatory activities.
4. Folder structure does not follow any data standards like EDM, IDMP, ICH or eCTD; therefore, the environment is often an uncontrolled listing of folders and files without a compliant structure.
5. Difficulty in creating reports on status of documents or submissions, forcing regulatory to create manual spreadsheets.
6. Metadata or “tagging” is uncontrolled and does not follow any standards like EDM, ICH, eCTD or TMF.
7. Conversion to PDF is difficult and it does not convert to ICH or FDA specifications for submissions.
8. Needs a separate e-signature solution that you must validate and connect yourself.
9. Workflows that do not match regulatory document control and creation practices.
10. Questionable data security and user permissions, compared to pharmaceutical software standards. For example, are you sure your system meets GDPR requirements today? 

These challenges run the gamut from being annoying, to the loss of many hours, to a status of noncompliant for electronic records for RIM functions.

When to Migrate from SharePoint to a RIM System

Migrate when two or more of these are true:

• You are preparing your first IND, CTA, or other health authority submission, or you are about to enter Phase 2.
• More than one vendor or consultant authors or reviews submission content, and people have started emailing drafts to avoid lost edits.
• You cannot produce a validated, time-stamped record of who created, changed, and approved a regulatory document.
• Folder structures and metadata differ by program, so finding the current or submitted version takes searching.
• You track health authority correspondence, commitments, or submission status in spreadsheets.
• An auditor, partner, or investor has asked for evidence you could not produce quickly.

The cost of waiting is usually migration size: the more documents and submissions sit in SharePoint, the larger the move.

How does a RIM System address these challenges? 

Unlike SharePoint, RIM Systems are designed expressly for pharmaceutical organizations. The building blocks of an effective RIM system are a compliant EDMS, submission and collaboration solution. In a nutshell, a RIM solution can prove via validation documentation that there is control, organization and access to electronic records and documents. Overall, using a purpose-built system can ease your processes and improve your time to submission.  

But how do you choose the right RIM system for you? 

First, consider your goals and requirements based on your submission workload and number of team members. Avoid buying a too complicated system with bells and whistles that may or may not be utilized in the next 6-36 months - it will make it more complicated for your team to get up and run quickly. Instead, establish the must-haves to meet regulatory compliance requirement as well as business process productivity tools that align to your workflows.     

Compliance Requirements for the Submission and Electronic Document Management (EDMS) Function must include:

1. Provide access control to documents based on users.
2. Provide an electronic record of person, date and action of every action in the system-i.e., Audit trail.
3. Provide centralized storage for data.
4. Provide high-level information security.

Second, we would recommend you look for the following business productivity capabilities in your RIM solution:

1. Facilitate information creation, retention, and distribution.
2. Ensure fast and easy information retrieval via a familiar folder structure based on industry standards like EDM, ICH CTD or TMF.
3. Support search.
4. Support content-driven collaboration. Utilizing an integrated powerful collaboration tool set that enables multi-users, online and offline functionality and simple tools to create new versions.
5. Offer automated workflows with straightforward options created specifically for RIM.
6. Pre-built authoring templates following ICH guidance.
7. Time saving automation for repeatable folder structures.
8. User interface that is pleasing and simple to understand. Will your users “get” it?
9. PDF conversion following ICH and FDA guidance.

So what is the best RIM System for your organization? 

Ultimately, each organization must analyze their own processes and stage of maturity to determine what scope of RIM System meets your needs. In addition, a RIM System alone is not a silver bullet. You must align your tools with the right people and processes to maximize your existing resources, manage vendor relationships, and stay on track to submission. For more on this topic, check out our whitepaper on building IND regulatory systems below. 

That said, a RIM System is an essential component of a successful regulatory team. So what should you look for? Here are 10 use cases we recommend all sponsors consider as they evaluate a system.

10 Regulatory Use Cases to look for in your RIM System:

1. Easy bulk import for CRFs, Literature References, and Datasets inclusive of applying metadata matching  ICH eCTD, TMF, EDM, RIM or internal company standards.
2. Capturing collaboration edits in real time and ensuring a compliant audit trail.
3. Ease of organizing  and applying a status to all submission documents.
4. Create content, track and meet Health Authority Commitments. e.g. DSUR, Annual Reports.
5. Manage Health Authority Correspondence: can you answer questions such as, "Where is the correspondence stored? How do I keep track by drug or biologic or contact? Which sequence is it in reference? When is a response due? What supporting content is required? 
6. Reporting / ease of answering the following example questions:
1. Status of submission- What state is the content in? 
2. What state is publishing in?
3. Where do I have active IND/CTAs?
4. Where do I have approval to run clinical trials?
5. Where am I approved for marketing authorization?
6. What is my planned submission schedule for the next 3-12 months?
7. How many person-hours will it take to complete the tasks associated with the planned submission schedule for 3-12 months?
7. Viewing and knowing what version of the documents each agency has under review.
8. Search capabilities - is it easy to find what you need?
9. Importing , viewing  and archiving eCTD sequences, in both v3.2.2 and v4.0. FDA has accepted eCTD v4.0 for new applications since September 16, 2024, and still supports v3.2.2.
10. Building eCTD content and knowing which documents are required.

What Migrating from SharePoint to a RIM System Involves

1. Inventory what is in SharePoint: sites, libraries, submissions, correspondence, versions, and owners.
2. Agree the target structure and metadata (the EDM Reference Model or your internal standard) and map SharePoint folders and columns to it.
3. Migrate documents with their metadata and version history, keep the audit history, and reconcile record counts.
4. Load validation evidence and SOPs for the new system, and run user acceptance.
5. Train users, cut over, and set SharePoint to read-only for migrated content.

Scope depends on document volume, the number of source systems, and how complete the metadata is.

How the Main RIM Options Compare for a SharePoint Migration

This is a neutral overview, not a ranking. It does not assess implementation quality, market share, or fit for your organization. Capabilities change, so confirm details with each vendor. Kivo is our product, so read this section with that in mind.

Whichever you evaluate, ask: Is validation evidence supplied? Does the audit trail record every action? How are existing documents, metadata, and version history migrated? Can you see correspondence and commitments by product? What does publishing cost, and who does it?

How Kivo Helps Teams Move off SharePoint

Kivo RIM replaces SharePoint folders, spreadsheets, and email threads with one compliant system built on a shared document core, with a native Part 11 e-signature included. RIM setup takes weeks, not months, and Kivo's Services team scopes SharePoint migrations individually based on document volume and source systems. Kivo holds SOC 2 Type 2, is rated 4.9/5 on G2, and supports 200+ sponsor, consultant, and CRO teams. Explore Kivo RIM or book a demo to see if it is a good fit for your team. 

Frequently Asked Questions

Is SharePoint 21 CFR Part 11 compliant?

Microsoft states no certification exists for complying with Part 11 and that customers must ensure their applications meet FDA requirements. SharePoint can be configured and validated for regulated use, but that qualification work, including audit trail and e-signature controls, is the customer's responsibility.

When should a biotech move from SharePoint to a RIM system?

Most teams move when they approach their first IND or CTA, enter Phase 2, add outside authors, or can no longer show a validated, auditable record of regulatory documents. Waiting increases the number of documents to migrate.

Can SharePoint documents be migrated into a RIM system?

Yes. A migration maps SharePoint folders and metadata to the RIM structure, carries version history, reconciles record counts, and is validated. Scope depends on document volume, the number of source systems, and how complete the metadata is.

Does a RIM system replace SharePoint entirely?

For regulatory documents and submissions, usually yes. Teams often keep SharePoint for non-regulated collaboration. Set SharePoint to read-only for migrated content so there is one controlled source of truth.

Related reading: The features that define a modern RIM system | What makes a RIM system implementation actually succeed | RIM capabilities that support a scaling regulatory team | How to submit an IND application