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SharePoint shares documents. Seal runs the GxP work they describe.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Acclinate cut quality cycle times by 50%. Start with one process beside SharePoint.

Where SharePoint falls short.

From Microsoft’s own documentation.

  • Part 11 certification
    “no certification exists”
    Your application
    Yours to qualify
    Seal
    A GxP workflow

    A GxP system you build yourself.

    Microsoft says no certification exists for Part 11, and customers who build applications subject to FDA regulation are responsible for meeting its requirements. In Seal, document control arrives as a GxP workflow.

    Microsoft Learn, December 2025
  • Audit (Standard)
    180 days
    Ten years
    A per-user add-on licence
    Seal
    Archived with approvals

    180 days of audit history.

    Audit (Standard) keeps audit records for 180 days, and ten years needs a per-user add-on licence; versions past a library’s limit are deleted unless a retention policy applies. In Seal, superseded versions are archived with their approvals.

    Microsoft Learn, Purview auditing
  • SharePoint, approved
    Visible to readers
    Seal, approved
    Agreed, not yet in force
    Seal, effective
    Once training is ready

    Approval publishes the draft.

    In a SharePoint library with content approval, approving a draft creates a new major version for readers. In Seal, approval and the effective date are separate decisions, tied to training and controlled copies.

    Microsoft Learn, Plan document versioning
  • Documents
    SharePoint
    Training
    Viva Learning, in Teams
    Seal
    The check runs at the step

    Training in another product.

    Microsoft describes Viva Learning as a learning hub in Teams, where managers track the reported completion of learning they recommend. In Seal, the check runs at the step.

    Microsoft Learn, November 2026
  • Copilot
    Creates a library
    Qualifying it
    Your responsibility
    Neil
    Drafts the change

    Its AI builds more SharePoint. Neil does the paperwork.

    Copilot in SharePoint creates sites, pages, lists and libraries from your content; each is part of an application you qualify. Neil prepares the change itself and the paperwork around it, for your team to approve.

    Microsoft Learn, September 2026

See it in Seal.

Real Seal screens with fictional test data: a procedure change, every record it reaches, and a batch record where the work is done.

  1. 1

    The procedure and what changes with it.

    SOP-PKG-014’s new step comes with the qualification, form and line-side copy that must change with it.

    Procedure SOP-PKG-014, line clearance, in Seal: proposed revision v05 under change CHG-014, a three-step line-clearance instruction, what changes from v04 with its implementation actions, and the effective-use decision still proposed.
    1. The new stepA qualified second person verifies clearance.
    2. What must change with itThe qualification, the execution form and the line-side copy.
    3. Earlier records keep their versionv04 execution records stay as they ran.
  2. 2

    One change reaches every record it touches.

    CHG-014 links the procedure to the training, the form and the copy on the line, with a decision for each.

    Change CHG-014, revision assessment, in Seal: the procedure SOP-PKG-014 and the affected training, form and line-side copy, a table of review decisions for training, execution, cutover and existing work, and approval still open.
    1. The change and what it reachesA procedure, a qualification, a form and a line-side copy.
    2. A decision for each areaTraining, execution, cutover and existing work.
    3. People approveNothing is approved until the evidence is reviewed.
  3. 3

    Each value at the step it belongs to.

    Batch B-041’s readings are recorded as the work happens, with its sample and its deviation linked to the record.

    Batch record B-041, post-mix hold and transfer, in Seal: the instruction to transfer within 45 minutes of completing the mix, process readings at 10:12, 10:42 and 11:04 with temperature and pH, and the linked lab sample IPC-041 and investigation DEV-018.
    1. The step’s limitTransfer within 45 minutes of completing the mix.
    2. Recorded as it happensMix complete at 10:12, transfer at 11:04: 52 minutes.
    3. The deviation, linkedDEV-018 sits on the batch record it concerns.

What Seal’s customers measured.

Each figure links to the customer’s story.

QualityAcclinate and Skye Biologics

−50%
quality cycle times at Acclinate, from a procedure change to everyone trained.Acclinate
−40%
non-conformances at Skye Biologics, with training checked before execution.Skye Biologics

RecordsMiAlgae and Bioventix

−75%
documentation time at MiAlgae, from the lab to commercial production.MiAlgae
−80%
document admin time at Bioventix, after two decades on paper.Bioventix

SharePoint and Seal, side by side.

Every source is listed under References.

SharePointSeal
What it isGeneral content platform¹The GxP execution system, with document control built in
Built forTeamwork and finding information¹Process development, the lab, manufacturing, batch release and quality
Data modelLists and document libraries²Primitives your team composes: record types, their relationships, steps and checks
AICopilot builds sites, lists and libraries³Neil, Seal’s AI agent, prepares changes to the process; your team approves them
GxP basisNo product has Part 11 certification; you qualify the application⁴A GxP workflow; your team approves the intended use, and selected tests run on each change prepared for review
Audit history180 days in Audit (Standard)⁵Kept with each document and record
Old versionsTrimmed or deleted by library limits⁶Superseded and archived with approvals
VersionsMajor and minor, with check-out²One effective version per document
ApprovalApproving a draft publishes it⁷Approved first; effective once training and checks are ready
TrainingViva Learning, a hub in Teams⁸Assigned from the change, by role
Getting startedFastTrack or a certified partner, then qualify¹⁹A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
SharePoint is good for sharing documents and intranet sites. Microsoft launched it in 2001 as a portal server, choosing the portal category because it “was an area of a lot of buzz”,¹⁰ with check-in, version tracking and approval routing for documents.¹¹ Twenty-five years on, it is still built around the list and the document library, each with its own settings for versions, approval and drafts.² Microsoft says lists can provide quick, effective solutions with little or no modification,¹² yet for GxP it says no certification exists for Part 11, and the customer who builds the application is responsible for meeting FDA requirements.⁴ Its AI, Knowledge Agent in preview from September 2025 and Copilot in SharePoint from September 2026, answers questions and creates sites, pages, lists and libraries from a description;¹³³ each is one more part to qualify. If you have a team to build, validate and maintain that application, it can work well. Few quality teams want to build their own.

1What SharePoint offers.

Microsoft describes SharePoint as a cloud service that helps organisations share and manage content, knowledge and applications.¹ Its building blocks are lists and document libraries: a library can require content approval, keep major or minor versions, limit how many are kept and require check-out before editing.²

2Neil does the paperwork across SharePoint. You sign.

You can leave the library where it is. Seal’s SharePoint connection shares selected versioned files from a SharePoint site with chosen Seal groups, to reference in documents, comments and Neil, your AI agent. It reads only and makes no changes in SharePoint, and opening the original uses each reader’s SharePoint permissions.

For a revision, Neil drafts the instruction from the source procedure, finds the forms, training and records it affects, and prepares the configured change with its verification for your team to review and approve. Neil is not used in GMP execution.

3Start beside SharePoint.

  1. Choose a procedure family where revisions keep missing the point of use, such as one whose forms or training drift after each change.
  2. Connect the SharePoint library read-only for the documents it references. Microsoft administrator consent may be required.
  3. Bring an existing revision and map it to the roles it affects. Neil drafts the configured workflow and your team checks it. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack to evaluate within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
  4. Follow the revision through approval, training and effectiveness before extending the workflow.
  5. Migrate the next family: import documents with their version history where it exists and establish controlled baselines before go-live. A file upload is not an approved baseline, and missing history is not invented.

References

  1. 1Introduction to SharePoint and OneDrive in Microsoft 365 for administrators, Microsoft Learn. https://learn.microsoft.com/en-us/sharepoint/introduction (read 5 November 2026)
  2. 2Enable and configure versioning for a list or library, Microsoft Support. https://support.microsoft.com/en-us/office/enable-and-configure-versioning-for-a-list-or-library-1555d642-23ee-446a-990a-bcab618c7a37 (read 5 November 2026)
  3. 3Get started with Copilot in SharePoint, Microsoft Learn, updated 25 September 2026. https://learn.microsoft.com/en-us/sharepoint/copilot-in-sharepoint-get-started (read 5 November 2026)
  4. 4Food and Drug Administration CFR Title 21 Part 11, Microsoft Compliance, Microsoft Learn, updated 4 December 2025. https://learn.microsoft.com/en-us/compliance/regulatory/offering-fda-cfr-title-21-part-11 (read 5 November 2026)
  5. 5Learn about auditing solutions in Microsoft Purview, Microsoft Learn. https://learn.microsoft.com/en-us/purview/audit-solutions-overview (read 5 November 2026)
  6. 6Version history limits for document library and OneDrive overview, Microsoft Learn. https://learn.microsoft.com/en-us/sharepoint/document-library-version-history-limits (read 5 November 2026)
  7. 7Plan document versioning, content approval, and check-out controls in SharePoint Server, Microsoft Learn. https://learn.microsoft.com/en-us/sharepoint/governance/versioning-content-approval-and-check-out-planning (read 5 November 2026)
  8. 8Overview of Microsoft Viva Learning, Microsoft Learn, updated 2 November 2026. https://learn.microsoft.com/en-us/viva/learning/overview-viva-learning (read 5 November 2026)
  9. 9Good Clinical, Laboratory, and Manufacturing Practices (GxP), Microsoft Compliance, Microsoft Learn, updated 2 June 2026. https://learn.microsoft.com/en-us/compliance/regulatory/offering-gxp (read 5 November 2026)
  10. 10SharePoint’s Founding Father, Jeff Teper, Talks About the SharePoint History, Vision, and Lessons Learned, SharePoint Experts blog archive, Microsoft Learn, 6 October 2009. https://learn.microsoft.com/en-us/archive/blogs/sharepointexperts/sharepoints-founding-father-jeff-teper-talks-about-the-sharepoint-history-vision-and-lessons-learned (read 5 November 2026)
  11. 11Microsoft Announces Branding and RC1 Availability of “Tahoe” Server, Microsoft News Center, 8 January 2001. https://news.microsoft.com/source/2001/01/08/microsoft-announces-branding-and-rc1-availability-of-tahoe-server/ (read 5 November 2026)
  12. 12Introduction to lists, Microsoft Support. https://support.microsoft.com/en-us/sharepoint/lists/get-started-with-sharepoint/introduction-to-lists (read 5 November 2026)
  13. 13Introducing Knowledge Agent in SharePoint, Microsoft SharePoint Blog, Microsoft Tech Community, 18 September 2025. https://techcommunity.microsoft.com/blog/spblog/introducing-knowledge-agent-in-sharepoint/4454154 (read 5 November 2026)

AQuestions and answers

Is Seal better than SharePoint?

Yes. SharePoint is good for sharing documents and intranet sites. Microsoft launched it in 2001 as a portal server, choosing the portal category because it “was an area of a lot of buzz”, with check-in, version tracking and approval routing for documents. Twenty-five years on, it is still built around the list and the document library, each with its own settings for versions, approval and drafts. Microsoft says lists can provide quick, effective solutions with little or no modification, yet for GxP it says no certification exists for Part 11, and the customer who builds the application is responsible for meeting FDA requirements. Its AI, Knowledge Agent in preview from September 2025 and Copilot in SharePoint from September 2026, answers questions and creates sites, pages, lists and libraries from a description; each is one more part to qualify. If you have a team to build, validate and maintain that application, it can work well. Few quality teams want to build their own. Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Moving from Google Drive, Acclinate cut the time from a procedure change to everyone trained by 50%.

Do we have to move our documents out of SharePoint?

No. Seal’s SharePoint connection shares selected versioned files with chosen Seal groups, for reference in documents, comments and Neil. It reads only, and opening the original uses each reader’s SharePoint permissions. Families of procedures move when you choose.

Can SharePoint be used for GxP document control?

Only once the regulated company has configured and qualified it. Microsoft says there is no GxP certification for cloud service providers and that computerised systems used in GxP processes require validation, and for Part 11 it says customers who build and deploy applications subject to FDA regulation are responsible for meeting FDA requirements. In Seal, document control is already a governed GxP workflow.

What does approval mean in each?

With SharePoint content approval, an approved draft becomes a new major version visible to readers. In Seal, approval records agreement to a version, and a separate effective date makes it the instruction in force once training, configuration and controlled copies are ready.

How does Copilot in SharePoint compare with Neil?

Copilot in SharePoint answers questions about SharePoint content and creates sites, pages, lists, libraries and simple approvals from a description. What it builds is still SharePoint, which Microsoft leaves the regulated company to qualify. Neil prepares changes to the process configured in Seal, with the forms, training and records each change affects and its verification, for your team to approve. Neil is not used in GMP execution.

How long does it take to start with Seal?

Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack to evaluate within 48 hours, configured from one of your procedures. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside SharePoint.

Keep SharePoint. Seal’s SharePoint connection reads selected versioned files, so Neil and your team can work from them while you start one procedure family in Seal, and nothing has to move on day one.

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