Home » Resources » Blogs » Validating SharePoint for Life Sciences Regulated Environments

Biotech, CMO, CRO, Medical Device, Pharma

Validating SharePoint for Life Sciences Regulated Environments

Hovsep Kirikian
April 11, 2022

Validating SharePoint can enable life sciences companies to deploy quality solutions in a highly secure and compliant environment.

Whether deployed on-premise or on the cloud …

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.

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.

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.

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.

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

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.

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.