Validating SharePoint can enable life sciences companies to deploy quality solutions in a highly secure and compliant environment.
The short version: SharePoint can serve as a GxP document and quality management platform when it is validated for its intended use. Before you validate, confirm whether the instance actually requires validation, document the business requirements, and map SharePoint's native and configured capabilities — security, audit trails, versioning, search, and workflows — to those requirements. This article walks through the areas to consider so you can turn SharePoint into a compliant EDMS or QMS without over-validating or leaving gaps.
Whether deployed on-premise or on the cloud, SharePoint comes in several deployment models that life sciences teams commonly evaluate:
- SharePoint on-prem
- SharePoint online
- SharePoint with Office 365
- SharePoint with Microsoft 365
- SharePoint on Azure (included in USDM's Cloud Assurance offering)
USDM Life Sciences can facilitate the configuration and qualification of SharePoint for GxP document management and quality management solutions, increase your organization's efficiency, and make you more competitive.
Determine whether SharePoint requires validation
Your first step in this process is to determine if the SharePoint instance requires validation, so be sure that you understand the system's intended use and document the business requirements. For example, if SharePoint is to be used as an Electronic Document Management System (EDMS), document how SharePoint will fulfill those requirements using native functionalities like a permissions grid and audit trail, custom functionalities such as workflows to enable review, approval, and archiving of documents, and integrations to third-party systems, such as DocuSign.
Scoping the effort up front keeps validation proportionate to risk. A modern, risk-based computer software assurance (CSA) approach focuses your testing on the functionality that actually impacts product quality, patient safety, and data integrity — rather than exhaustively scripting every feature. Pairing that scoping discipline with strong validation lifecycle management helps your team keep the system in a validated state as SharePoint evolves through Microsoft's release cadence.
Before you validate, answer this: What is SharePoint's intended use, and which requirements are GxP-relevant? If the platform manages records that support a regulated decision, document those requirements first — then validate only what risk demands.
Following are some areas of consideration when validating a GxP application and how SharePoint can help fulfill the business requirements of each area.
Security
SharePoint offers an elaborate system of access control based on user permission levels ranging from View Only access to Full Control (create, modify, delete, share documents, etc.). SharePoint also provides multi-factor authentication, backup, automatic anti-malware protection, and can generate alerts when users are about to share sensitive information.
In addition to SharePoint's security features, USDM can provide the expertise to help you meet good cybersecurity practices to manage threats and risks within your organization. Because SharePoint frequently connects to third-party systems for signatures and downstream processing, those integrations also belong in your third-party risk management program.
Compliance
The SharePoint Audit log tracks user activity, including creating, accessing, editing, sharing, and deleting documents, plus user accounts and login information, site creation, and site settings changes. With USDM's vast experience with audits and assessments, we ensure that SharePoint meets your regulatory requirements while identifying gaps and potential risks.
For EDMS and QMS use cases, those audit-log and access-control capabilities are what allow SharePoint to support 21 CFR Part 11 expectations around electronic records and electronic signatures. The same controls underpin your broader data integrity posture — ensuring records remain attributable, legible, contemporaneous, original, and accurate throughout their lifecycle.
A platform is only compliant when its controls are validated against documented, intended use — not when a feature list says it could be.
Document Sharing and Co-Authoring
With SharePoint, you can easily share and co-author documents with people inside or outside of your organization. Security settings can be set from the file level, making it simple to share a document, a folder, or a site. When co-authoring, multiple individuals can edit simultaneously; SharePoint will lock sections that users are working on, then update the document as changes are made.
Versioning
The versioning feature in SharePoint maintains your version history within the document. New versions are automatically added when the document is saved, and you can roll back to previous versions. You can also track major versions (approved documents) and minor versions (which contain edits that have not yet been approved).
Searching
Enforcing GxP document management, searching in SharePoint only returns the files you have access to and your private files will not show up in someone else's search. SharePoint lets you add metadata to help with searching. For example, documents that are created by multiple departments concerning the same project. Adding these metadata fields to the document lets you search against the project name to retrieve documents created from all departments, regardless of the folder structure those documents live in.
Workflows
Workflows can greatly increase the ROI of implementing and validating SharePoint. They can streamline business processes such as getting approvals, capturing feedback on documents, and alerting the team when an individual has completed their contribution to a document. Using standard and custom workflows, SharePoint supports quality management solutions, including:
- Document Management
- Change Management
- Deviations, CAPA, and Complaint Handling
A working model for validating SharePoint as a GxP platform
- Define intended use. Document what SharePoint will do — EDMS, QMS, or a configured subset — and which of those uses are GxP-relevant.
- Capture business requirements. Translate intended use into testable requirements covering security, audit trail, versioning, search, and workflows.
- Assess risk and scope. Apply a CSA mindset so the depth of testing matches the risk each function carries.
- Configure and qualify. Map native and custom functionality (permissions grids, audit logs, workflows, third-party integrations) to the requirements and qualify them.
- Sustain the validated state. Manage change, reviews, and periodic assessments so updates and new integrations do not silently break compliance.
Conclusion
Life sciences companies can use Microsoft SharePoint to fulfill many compliance and quality requirements. From GxP document management to more complex workflows like change control and CAPA, SharePoint's standard and customizable features provide solutions for this highly secure and regulatory compliant industry.
USDM Life Sciences is committed to helping organizations become more efficient and competitive. Our team of experts brings decades of industry and SharePoint experience to help turn SharePoint into the document and Quality Management System your company needs.
FAQ: Validating SharePoint for Life Sciences
Does every SharePoint instance need to be validated?
No. The first step is to determine whether validation is required by understanding the system's intended use and documenting the business requirements. If SharePoint manages GxP records — for example, as an Electronic Document Management System — then the functionality supporting those records should be validated.
Can SharePoint be used as an EDMS or quality management system?
Yes. Using native functionality like permissions grids and audit trails, custom functionality such as review-and-approval workflows, and integrations to third-party systems, SharePoint can fulfill EDMS requirements and support quality management solutions including document management, change management, and deviations, CAPA, and complaint handling.
How does SharePoint support 21 CFR Part 11?
SharePoint's access controls, multi-factor authentication, and audit log — which tracks creating, accessing, editing, sharing, and deleting documents along with account and configuration changes — provide the electronic-records and electronic-signature controls that, when validated for intended use, support 21 CFR Part 11 expectations.
How does versioning help with compliance?
SharePoint maintains version history within each document, automatically adds new versions on save, allows rollback to prior versions, and distinguishes major (approved) from minor (not yet approved) versions — supporting controlled document lifecycles and data integrity.
What does USDM provide beyond SharePoint's built-in features?
USDM brings decades of industry and SharePoint experience to configure and qualify SharePoint for GxP use, apply audit and assessment expertise to identify gaps and risks, and help establish good cybersecurity and risk-management practices around the platform.
Ready to turn SharePoint into a validated GxP platform? USDM can help you scope validation to risk, configure and qualify SharePoint as your EDMS or QMS, and keep it in a compliant state as it evolves. Contact us to get started.
Related Content
Partnership page: Microsoft
Case study: Validation of SharePoint for GxP Content Management Solution
Webinar: Accelerate Your Journey to the Cloud: Move your GxP Regulated Workloads to Microsoft Azure
Webinar: Your IT Roadmap – Guidance for Early-Stage Life Sciences Startups
About the Author
Hovsep Kirikian is a project manager at USDM and has more than 12 years of experience managing projects in the life sciences industry, with specific focus on regulatory compliance, validation, equipment lifecycle and sustainability, laboratory operations, and data management across all phases of the product life cycle.
Hovsep's recent content
4 Simple Steps to Ensure Data Integrity in Quality Control Labs
Customized CPET Analysis Workbook