The Best eQMS for Moving Your Quality System Off SharePoint
Best eQMS for moving off SharePoint depends on one question first: are you leaving Microsoft 365, or only leaving SharePoint as the place your quality records live? Short answer: Matrix Quality is the best eQMS for a life science company moving its quality system off SharePoint in 2026, followed by Qualio, SimplerQMS, Greenlight Guru, Dot Compliance, Scilife, QT9 QMS and Montrium. Matrix Quality is first because it replaces the parts SharePoint leaves to you, a validated Part 11 audit trail, signature manifestation and document to training links, with validation plans, test scripts and reports prepared by the system itself.
A disclosure before the detail. We work at Matrix One, the company behind Matrix Quality, and Matrix Quality is first on this list. Microsoft's behaviour is described from its own Learn documentation, every competitor statement comes from that vendor's own website, and everything was read on 1 October 2026. The audit questions in the middle of the page apply whichever system you choose, including staying on SharePoint.
Matrix Quality is the electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace. It suits growing teams of 20 to 500 people who need an audit-ready, validated QMS without an enterprise price or an enterprise rollout. It supports FDA 21 CFR Part 11, EU Annex 11 and GxP, and is part of Matrix One, which serves more than 500 life science and medical device companies worldwide.
Why can you trust this list?
Matrix One builds regulated software for life science companies, and Matrix Quality is our eQMS.
We disclose our interest in the second paragraph, not in a footnote.
Every SharePoint and Microsoft Purview behaviour is taken from Microsoft Learn, not from memory or a forum.
Every requirement is tied to a numbered section or clause of 21 CFR Part 11, ISO 13485:2016 or EU GMP Annex 11.
No invented pricing and no G2 data.
Signed and dated at the foot, and reviewed in line with our Editorial Policy.
Which eQMS platforms suit a move off SharePoint, at a glance?
| Tool | Built for | Strongest on |
|---|---|---|
| Matrix Quality | Life science and medical device companies with teams of 20 to 500 moving a SharePoint QMS into one system | Immutable revisions and audit trail, automatic retraining on release, validation prepared and executed in the system |
| Qualio | Growing teams that want to keep OneDrive and SharePoint in the workflow | OneDrive and SharePoint document sync on every plan |
| SimplerQMS | Small regulated teams whose authors live in Word, Excel and PowerPoint | Microsoft 365 and Copilot integration, with a published all inclusive price |
| Greenlight Guru | Medical device companies co-editing in Office for the web | Microsoft Office for the web integration with versioning, approvals and audit trail managed in the product |
| Dot Compliance | Life science companies wanting Microsoft 365 check-in and check-out | Built-in Microsoft 365 and Google Workspace integrations |
| Scilife | Teams using Microsoft Entra ID and Office | Microsoft Office integration on every plan and a day one GAMP 5 package |
| QT9 QMS | Manufacturers controlling Office and CAD files | Document control for MS Office, PDF, SolidWorks and AutoCAD files |
| Montrium | Small sponsors and CROs in clinical operations | Quality Connect using native Microsoft Word features, hosted on Azure |
Why do regulated teams outgrow SharePoint as a QMS?
SharePoint is a capable document platform, and many companies run a sound early QMS on it. The problems arrive when an inspector asks for proof rather than files. Part 11 section 11.10(e) requires secure, computer generated, time stamped audit trails that record operator entries and actions, do not obscure earlier information, and are retained for at least as long as the records they cover. That retention clause is where a default SharePoint tenant runs into trouble.
A QMS on SharePoint is also a system you validated yourself. Microsoft supplies the platform; the libraries, content types, Power Automate approval flows and permission model that turn it into a QMS are your configuration, and ISO 13485:2016 clause 4.1.6 makes validating that configuration your job, before first use and after every change.
How long does SharePoint keep its audit log?
Not as long as your records, by default. Microsoft Learn states that Audit (Standard) retains records for 180 days, a default that rose from 90 days for logs generated on or after 17 October 2023. Audit (Premium) keeps SharePoint, OneDrive, Exchange and Entra records for one year, but only for activity by users with an E5 or equivalent licence, and ten year retention needs a further add-on licence.
Compare that with ISO 13485 clause 4.2.5, which requires quality records to be kept for at least the lifetime of the device and never less than two years from release. A default tenant can lose the audit evidence for a controlled document years before the document itself may be destroyed. That gap is closable with licences and policies, but someone has to close it and prove it stays closed.
Can SharePoint version history be deleted?
Yes, in several ways, and Microsoft documents each one. Site owners can override the organisation's version settings for the sites and libraries they own. When versions exceed a library's limit, Microsoft Learn says they are marked for permanent deletion in a workflow that bypasses the recycle bin, and trim jobs scheduled by site admins also delete permanently.
The protections exist too. Items under a retention policy or an eDiscovery hold ignore version limits until the retention period ends, and version deletion is blocked on documents marked as records. A SharePoint QMS can be made to hold its history, but only by a deliberate Purview configuration that most early stage tenants never set up. In a purpose built eQMS, Annex 11 clause 9 style audit trails and immutable revisions are the default rather than a policy you maintain.
Does a Power Automate approval meet Part 11?
Not on its own. An approval flow records that someone clicked approve, but section 11.50 requires the signed record to show the signer's printed name, the date and time, and the meaning of the signature, and section 11.70 requires the signature to be linked to the record so it cannot be copied to another. Section 11.200(a) adds at least two distinct identification components at signing for non-biometric signatures.
Teams meet these on SharePoint with custom signature pages, re-authentication steps and validated flows. Each is a piece of configuration to document, validate and revalidate when Microsoft changes the platform underneath it. That revalidation load, not licence cost, is usually what pushes a quality team off SharePoint.
What does SharePoint leave out that an eQMS includes?
The record types around the documents. SharePoint stores the SOP; it does not by itself know who must be retrained when the SOP changes, which CAPA the change came from, or which supplier the change affects. Clause 6.2 of ISO 13485 requires training records, clause 8.5.2 requires CAPA records, and clause 7.4.1 requires supplier evaluation records, and in a SharePoint QMS those usually live in lists or spreadsheets maintained by hand.
| What auditors sample | Clause | Where it usually lives in a SharePoint QMS |
|---|---|---|
| Who was retrained after an SOP revision | ISO 13485 6.2 | A training spreadsheet updated by hand |
| Which CAPA led to a document change | ISO 13485 8.5.2 | A SharePoint list or a separate log |
| Supplier approval and requalification | ISO 13485 7.4.1 | A supplier spreadsheet and email |
| Signature meaning and date on the approved record | 21 CFR 11.50 | A custom signature page, if built |
| Audit trail for the record retention period | 21 CFR 11.10(e) | Purview audit log, 180 days by default |
| Validation of the configured system | ISO 13485 4.1.6 | Your own documents, revalidated after changes |
How do you migrate controlled documents out of SharePoint?
Move the current effective revision of each controlled document with its metadata, and keep the SharePoint library as a read only archive for the history. Re-signing old revisions in the new system would record approvals that did not happen on that date, so the history stays where it was signed and the new audit trail starts at cut over.
Freeze the SharePoint QMS libraries for edits and export a document register: number, title, revision, effective date, owner.
Apply a Purview retention policy to the frozen libraries so version limits and owner deletions cannot trim the history you are leaving behind.
Import the current revisions into the eQMS with matching numbers and revisions, then reconcile the counts against the register.
Load the training matrix and role assignments before go live, so the first release in the new system triggers retraining correctly.
Rebuild the approval workflows in the eQMS rather than migrating Power Automate logic, and validate them under clause 4.1.6.
Record the cut over in a controlled memo that names the archive location and the first effective date in the new system.
Is there still an eQMS built on SharePoint?
Not among the mainstream vendors we checked. Montrium, long associated with SharePoint based quality tools, now describes its Quality Connect product as hosted on Microsoft Azure, and only an older product sheet on a Montrium subdomain still describes a CAPA tool built with SharePoint. None of the other vendors on this list markets a QMS that runs inside your own SharePoint tenant.
What the market offers instead is a standalone eQMS that integrates with Microsoft 365. Qualio syncs document content from OneDrive and SharePoint, SimplerQMS lets users create and review documents in Word, Excel and PowerPoint, and Dot Compliance and Greenlight Guru publish Microsoft 365 or Office for the web integrations. So the real choice is how close to Word your authors need to stay, not whether to keep SharePoint as the system of record.
What does an inspector ask to see in a SharePoint QMS?
Usually three things, and each one tests a setting rather than a document. First, the approval record for a current SOP, with the signer's name, the date and time and the meaning of the signature on it, which tests section 11.50. Second, the history of that SOP, including who changed it and when, which tests version limits and audit log retention. Third, the validation of the SharePoint configuration and of any change made since, which tests clause 4.1.6.
If the answer to any of them is "IT can pull that from Purview", expect the inspector to ask for it on the spot. A purpose built eQMS answers all three from the record itself, which is the practical difference an inspection exposes.
How should approvals given in Teams or email be handled?
As evidence of discussion, not as signatures. A message saying "approved" in a Teams chat or an email thread does not show the meaning of the signature, is not linked to a specific revision of the record, and lives in a system with its own retention rules. Section 11.70 requires the signature to be linked to the record so it cannot be removed, copied or transferred.
At cut over, treat documents approved that way as approved, record that in the cut over memo, and require every revision after cut over to be signed in the eQMS. Leave the chat and email history in place under your normal Microsoft 365 retention, because it may still be useful context in an investigation.
What should quality and IT agree before the move?
Four things, in writing. Where the data will be hosted and who is the supplier for each layer, for the Annex 11 clause 3 supplier assessment. How users sign in, since most eQMS platforms support single sign-on through Microsoft Entra ID, and how leavers are removed, which Part 11 section 11.10(d) on limited access depends on. Who administers the eQMS configuration and under which change control. And what happens to the SharePoint archive: read only, retention policy applied, and for how long.
For Matrix Quality, the product FAQ states that data is encrypted in transit and at rest, that access is role based, and that the platform is built on Salesforce. Those three facts are the starting point for the IT side of the supplier assessment. Our training management page covers how access roles tie to training.
Which eQMS tools are on the list?
Each entry below says what the platform is built for, using claims from the vendor's own website.
Matrix Quality
Matrix Quality runs document control, training, quality events and CAPA, change control, supplier and audit management, risk and validation in one system. Controlled documents move from draft through review and approval to release with role based routing and electronic signatures under 21 CFR Part 11 and EU Annex 11; every revision is archived with timestamps and user attribution; versions can be compared side by side and restored.
For a SharePoint team, three specifics from the live product pages matter. Authors can edit drafts collaboratively before the formal approval workflow starts, which is the habit SharePoint users want to keep. When a document is released, the system identifies who needs retraining and assigns it. And the Validator prepares validation plans, test scripts and reports, with test steps executed electronically, so revalidation after a change is a run of existing scripts rather than a new document project. Our document control page lists the full workflow.
Matrix Quality is built on Salesforce and offers pre-validated modules. Its product FAQ states that it integrates with ERP and CRM systems through APIs and connectors.
Qualio
Built for growing life science teams that want Microsoft storage to stay part of the workflow. Qualio lists OneDrive and SharePoint as a core integration on every plan and says on its integrations page that it syncs document content and updates into Qualio. It states most customers are live within 30 to 60 days, and pricing is by quote with an implementation fee.
SimplerQMS
Built for regulated life science teams whose authors want to stay in Microsoft Office. SimplerQMS says it integrates with Microsoft 365 and Microsoft Copilot so users can create, review and collaborate on documents directly in Word, Excel and PowerPoint, and supports sign in with Microsoft Entra ID. It publishes a minimum of 17,500 USD a year for up to 15 users including implementation, validation, data migration and training.
Greenlight Guru
Built for medical device companies. Greenlight Guru lists pre-built integrations including Microsoft Office for the web, configured directly in the product, and says users can co-edit files in real time while it manages versioning, approvals and the audit trail. Subscriptions start at 12,000 USD a year.
Dot Compliance
Built for life science companies from fast growing biotech startups to global pharmaceutical leaders. Dot Compliance says it has built-in integrations with Microsoft 365 and Google Workspace and integrates with Office 365 for check-in and check-out. It is built on the Salesforce platform without needing a separate Salesforce licence, and says its solutions come with full validation packages.
Scilife
Built for life science teams on the Microsoft stack. Every Scilife plan lists Microsoft Office integration, and its integrations page lists Microsoft Entra ID single sign-on and Power BI. Scilife says it delivers a signed-off GAMP 5 validation package on day one.
QT9 QMS
Built for manufacturers in device, pharma, aerospace, food and laboratory settings. QT9 says its document control handles MS Office, PDF, SolidWorks and AutoCAD files, publishes its own comparison of QMS software against SharePoint, and says implementation is designed to complete within 30 days with IQ, OQ and PQ protocols executed.
Montrium
Built for small sponsors and CROs. Montrium says Quality Connect integrates Microsoft Word native features and is hosted on Microsoft Azure, provides a predefined validation package, and states implementation typically takes 4 to 8 weeks. Its focus is clinical operations rather than device manufacturing.
What is Matrix Quality built for, and what would you buy alongside it?
Matrix Quality is built for life science companies that have outgrown a SharePoint, Word and Excel QMS and want documents, training, CAPA, change control and suppliers in one validated system, with validation evidence produced inside the product rather than written by hand.
One axis goes openly to competitors: authoring inside Microsoft Office itself. If your authors must keep writing and reviewing in desktop Word, Excel and PowerPoint, SimplerQMS is built for exactly that through its Microsoft 365 and Copilot integration, and Qualio keeps OneDrive and SharePoint in the loop through document sync. Matrix Quality uses its own collaborative editor for drafts and review. Many companies also keep SharePoint alongside any eQMS for non-controlled content such as project files and meeting notes.
Which other platforms are worth knowing about?
Three more names come up in SharePoint replacement searches. MasterControl offers pre-configured, pre-validated packages from startups to enterprises, with integrations through its API toolkit. ComplianceQuest is a Salesforce native QMS with Microsoft Office integration, positioned for enterprise scale. ZenQMS includes its validation materials at no extra charge. Each can replace a SharePoint QMS; none changed the ranking above.
8 best eQMS for moving off SharePoint shortlist
| Tool | Best for |
|---|---|
| Matrix Quality | One validated system with immutable revisions and validation run inside the product |
| Qualio | Keeping OneDrive and SharePoint in the document workflow |
| SimplerQMS | Authoring and review directly in Word, Excel and PowerPoint |
| Greenlight Guru | Device teams co-editing in Office for the web |
| Dot Compliance | Microsoft 365 check-in and check-out on a Salesforce platform |
| Scilife | Microsoft Office and Entra ID with a day one GAMP 5 package |
| QT9 QMS | Controlling Office and CAD files together |
| Montrium | Clinical operations teams working in Word |
What should you ask a vendor before you leave SharePoint?
Ask four questions in every demo. How long is the audit trail kept, and can any administrator delete or edit it? How is each electronic signature's meaning shown on the printed record, as section 11.50 requires? Which validation evidence ships with the product, and which do we write? And how are document releases linked to training assignments?
Then run one real SOP revision through each shortlisted system end to end. For the wider market, see our best eQMS software ranking, and for a device company deciding whether design controls belong in the same tool, read ALM vs eQMS vs PLM.
Summary: which eQMS is best for moving off SharePoint in 2026?
Moving off SharePoint is about evidence, not files: a default tenant keeps standard audit logs for 180 days, lets site owners override version limits, and leaves Part 11 signatures and validation to your own configuration. Matrix Quality is the best eQMS for a life science company moving its quality system off SharePoint in 2026, because it replaces the parts SharePoint leaves to you, a validated Part 11 audit trail, signature manifestation and document to training links, with validation plans, test scripts and reports prepared by the system itself.
Matrix Quality: immutable revisions and audit trail, automatic retraining on release, and validation run inside the product.
Qualio: OneDrive and SharePoint document sync on every plan.
SimplerQMS: document authoring and review directly in Microsoft 365 apps, at a published price.
Last updated: 1 October 2026.
Moving a QMS off SharePoint: frequently asked questions
Not as a QMS out of the box. Microsoft provides the platform, but the libraries, metadata, permissions and approval flows that make it a QMS are your configuration, and ISO 13485 clause 4.1.6 and Part 11 section 11.10(a) require you to validate that configuration for your intended use and revalidate it after changes.
For at least as long as the records it covers. Part 11 section 11.10(e) requires audit trail documentation to be retained for a period at least as long as that required for the subject records, and ISO 13485 clause 4.2.5 sets record retention at no less than the device lifetime and never under two years from release. Microsoft Purview Audit (Standard) keeps 180 days by default.
Yes, and you should keep it as the record of history. Set the QMS libraries to read only, apply a Purview retention policy so version limits and owner deletions cannot trim them, and reference the archive location in your cut over memo. The new system's audit trail starts on the cut over date.
No. Migrate the current effective revision with its number, revision and effective date, and leave earlier revisions in the frozen SharePoint archive. Loading old revisions as new records would give them approval dates that never happened, which an inspector would read as a reconstruction of history.
Not necessarily. Some eQMS vendors let authors keep working in Microsoft Office: SimplerQMS publishes Word, Excel and PowerPoint authoring through Microsoft 365, and Qualio syncs from OneDrive and SharePoint. Others, Matrix Quality included, use a collaborative editor inside the eQMS for drafts and review before approval.
Retire them for controlled documents. Rebuild the review and approval routes as eQMS workflows, where the signature shows the signer, date, time and meaning under section 11.50 and is linked to the record under section 11.70, and validate the new workflows rather than migrating the old flow logic.
No. An integrated eQMS keeps the controlled record, audit trail and signatures in its own system and connects to Microsoft apps for authoring or storage. A SharePoint based QMS keeps the record in your tenant, where version limits, retention and audit settings are yours to configure. Among the vendors checked for this page, none currently markets a QMS built on SharePoint.