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Document Management System vs. SharePoint for regulated industries

In this article, we will cover some of the main aspects that Quality Managers in complex organizations should be looking at when choosing between different solutions to handle documentation, especially in international businesses with a strict regulatory scenario.


As many Quality leaders come to our specialized team with questions about the relevance and benefits of using a Document Management (DM) system compared to using SharePoint, a generic tool to manage and share documents that usually comes with a subscription to other Microsoft products, we gathered here some important aspects to keep in mind when making an informed choice that is right for the needs of your organization.

Table of Contents

  1. Readiness to meet Quality requirements

  2. Security, tracking, and access permissions

  3. Document lifecycle management & Workflow automation

  4. Metadata management and document search capabilities

  5. Conclusion


Readiness to meet Quality requirements

Although Microsoft SharePoint is a reliable and highly configurable tool, it was not designed with the purpose of helping Quality leaders manage complex documentation and meet strict global compliance requirements. SharePoint might be commonly used by smaller organizations where document control and Quality Management maturity level are still at very early stages of development, once it lacks out-of-the-box features that capture, manage, share, and secure documents for specific quality-related activities.


Adapting SharePoint to highly regulated environments makes a very specific use case that requires a lot of IT resources, time, and development effort that mostly turn out to be unnecessarily complex and expensive compared to ready-to-use document management solutions.


If you carefully choose the proper Document Management solution for your business, you will benefit from a framework purposely built for more complex structures and interactions, with Quality Compliance as the central point for several departments to collaborate using a single source of truth.


When a Document Management platform is part of an integrated Quality Management System, it also plays a very important role in connecting information related to Risk, Compliance, CAPAs, Incidents, Quality Control, Quality Assurance, and Continuous Improvement, creating a very strategic repository of information and processes that are intrinsically related.


It is also relevant to emphasize that certifications like ISO 9001:2015 have very specific requirements related to document creation, approval, distribution, version control, updates, life cycle management, and information retrieval, so having a Document Management system that is already in line with those requirements will save your company time and money during implementation, training, and maintenance.


Security, tracking, and access permissions

While it is possible to grant access to folders and files using SharePoint, this functionality is basic compared to a dedicated Document Management software, where more sophisticated mechanisms of permission-based access can be defined by more specific criteria. Another advantage of Document Management solutions is access management capabilities that can be set up at many hierarchical levels, so Quality leaders of complex organizations can manage roles and permissions centrally and locally, avoiding unnecessary escalations and IT dependency.


Most Document Management systems offer advanced security features, including access controls, encryption, audit trails, SSO, and user permissions. This is crucial for organizations dealing with sensitive or confidential documents, ensuring access to precisely what information collaborators may need to perform their jobs effectively.


Another security advantage of Document Management systems for compliance and governance purposes is having automatic document versioning and detailed audit trail records with the complete history of activities performed in a document, such as creation, modification, visualization, approval, and deletion.


Document lifecycle management & Workflow automation

One of the limitations of using SharePoint to manage Quality-related documents is the lack of advanced functionalities for granular version control, making it harder for teams to clearly distinguish which is the latest version of a document instead of scrolling through a document that already has become obsolete. Document Management systems provide advanced version control and allow users to manage metadata, which is essential to document search capabilities, particularly in global operations.


Document Management platforms also combine the convenience of having a full document life-cycle management from initial development to proper archive connected with built-in structured workflows, so stakeholders are reminded on time about upcoming actions and deadlines. These functionalities enable companies to standardize the way of working and harmonize document handling procedures worldwide, allowing admins to create predetermined templates that help teams get started faster without reinventing the wheel and setting up complex configurations from scratch.


Metadata management and document search capabilities

Storing large volumes of documents is not a problem for SharePoint; however, to effectively scale documentation management as your organization grows, a Document Management system will provide more efficient storage and retrieval mechanisms, ensuring the latest version of a document is available to everyone without a trace of doubt, even in extensive document libraries.


Having all document-related content systematically organized and easy to retrieve with more sophisticated search mechanisms saves Quality teams a lot of time dealing with thousands of documents in different languages and locations, for various product lines. Document Management systems also offer advanced reporting and analytics functionalities for internal or external audits, making tracking the content library inventory, actions taken, number of viewers, approval history, and many other related strategic indicators easier.


Conclusion:


If your company must comply with strict standards in regulated industries, adopting a Document Management system might be more time and cost-effective than investing IT and Quality resources to create a customized configuration for SharePoint exclusively for your business. When part of a QMS platform, a variety of Document Management functionalities already come with a set-up ready for ISO and FDA standards, with proven satisfactory experiences of other clients that use it for the same purpose, in the same industry, or with the same long-term objectives. We created this comparison chart to help you visualize some of the features highlighted in our text.

Feature comparison for use in Quality Management

QMS Document Managament System

SharePoint

Company Size

All sizes

Small to medium

Pre-configured to meet Quality requirements*

Yes

No

Regulatory impact on business

High

Low

Automated workflows*

Yes

No

Volume of documents

Medium to High

Low to Medium

Metadata and advanced search tools*

Yes

No

Versioning control*

Detailed granular control

Limited

Audit trail

Complete

Basic

​Document lifecycle management*

Yes

No

*Default functionalities without additional development



It is always good to highlight that specific features and capabilities of both Document Management software solutions and SharePoint can vary by vendor, version, and configuration. To evaluate the best fit for your organization's specific needs, you can schedule a personalized demo with our specialists to explore all possibilities with the Document Management module of our Icologiq Elements Enterprise QMS.

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