Scilife vs SharePoint: QMS software comparison

SharePoint is a general-purpose document management and collaboration tool from Microsoft. It provides centralized document storage, user permissions, version control, and basic workflow automation capabilities.

While it’s possible to configure SharePoint to manage quality documents and approvals, it was never designed to function as a Quality Management System (QMS). Many life sciences companies start with SharePoint because it’s familiar, flexible, and already available within their organization. But as compliance requirements evolve, their limitations become clear.

SharePoint lacks the built-in compliance capabilities, such as electronic signatures, audit trails, controlled workflows, and CAPA management, that FDA, EMA, and ISO standards demand. Meeting these regulatory expectations usually requires extensive customization, validation, and ongoing IT support.

That’s why organizations eventually transition to QMS software like Scilife, which is built for life sciences, comes pre-validated, and delivers out-of-the-box compliance with GxP, FDA 21 CFR Part 11, and EU Annex 11.

No, Microsoft SharePoint is not CFR 21 Part 11 compliant out of the box. While it includes basic features like version control and user permissions, it lacks the specific technical and procedural controls required under FDA 21 CFR Part 11, such as validated electronic signatures, detailed audit trails, and secure system validation.

To achieve Part 11 compliance with SharePoint, organizations must customize and validate the system extensively, often using third-party add-ons and complex workflows. This makes maintaining compliance costly, time-consuming, and highly IT-dependent.

By contrast, Scilife is built and validated for CFR 21 Part 11 compliance, with secure audit trails, electronic signatures, and full traceability integrated across every module.

There’s a huge amount of work to do and associated costs with developing a life sciences QMS with SharePoint for industries such as medical devices, pharma, and biotech. You need to keep in mind that you’ll have to build your own compliance framework from scratch, including CAPA management, automated workflows, 21 CFR Part 11–compliant electronic signatures, validation, and integrations.

In most cases, companies must bring in specialized consultants to configure and validate the system. On top of that, you’ll need to purchase enough user licenses and likely allocate a dedicated IT resource to maintain, troubleshoot, and revalidate the system once it’s up and running. 

SharePoint can be a great collaboration and document management tool, but it has limited use for quality management.

Teams that try to adapt SharePoint as a QMS often face challenges such as disconnected quality processes, limited audit trails, and time-consuming change management. Over time, it turns into a patchwork solution, capable of handling some aspects of quality, but only through extensive manual configuration, documentation, and validation. This creates ongoing compliance risks, heavy IT dependency, and additional expenses.

Unlike SharePoint, which only manages documents by default, Scilife unifies training, CAPA, audits, risks, suppliers, and equipment management in one connected, inspection-ready platform. It comes with a complete GAMP 5 validation package (IQ/OQ/PQ) and three environments (test, validation, and production), ensuring compliance and traceability.

While SharePoint is sometimes used for QMS by small teams, it only works up to a certain point. The reality is that SharePoint does not scale with an increased pace of manufacturing, hiring, or regulatory compliance. 

But outgrowing SharePoint isn’t a bad thing. When it no longer supports your quality processes, workflows, and events efficiently, it means your operations have matured beyond what a general-purpose tool can handle. Continuing to force SharePoint to fit regulated needs often leads to inefficiency, compliance risk, and diminishing returns.

For organizations ready to move beyond these limitations, eQMS solutions like Scilife offer a purpose-built, validated, and scalable alternative,  one designed to grow with your quality system.