Product · Governance & Compliance

Controlled Documents for Microsoft SharePoint

Document control directly in Microsoft SharePoint — controlled approval, automatic review cycles and audit-proof records. Standards-compliant, with no parallel system and no data migration.

ISO 9001ISO 13485GMPSanaCERTJACIEFDA 21 CFR Part 11
Available for
SharePoint OnlineSharePoint OnlineSharePoint On-PremisesSharePoint On-Premises
Quality manual QM-001
Controlled Documents
Valid
Approved on 14/09/2025
by A. Meier (AM) · T. Berger (TB)
Document type
Policy
Scope
Entire organisation
Version
Major version 3.0
Review interval
12 months
Next review14/09/2026
Created›Consulted›Approved›Valid
The risk

Uncontrolled documents are an underestimated risk

Outdated versions, approvals by email, forgotten review dates — in regulated environments this leads straight to audit risks. Do these situations sound familiar?

Which version is valid?

Several versions are in circulation — nobody knows for sure which one is current and valid.

Approval by email

Approvals run through email chains. Who agreed, and when? Barely provable in an audit.

Forgotten review dates

Documents expire without anyone being notified. Outdated content stays in circulation.

Unclear responsibilities

Who is responsible, who is allowed to make changes? Without a system there is no reliable answer.

Certification at risk

ISO, GMP and SanaCERT require demonstrable document control — otherwise non-conformities loom.

Searching in vain

Documents are scattered across drives and emails. Finding them is a matter of luck.

The approval process

From creation to valid version

Fully automated and traceable — every step documented in an audit-proof way.

  1. 01

    Create

    The author creates the document from a template — as a draft, not yet visible.

  2. 02

    Publish

    Request publication with one click, choose the review interval and add a comment.

  3. 03

    Consult

    Optionally invite experts to give feedback — in parallel with the approval process.

  4. 04

    Approve

    Approvers receive a task by email and decide, with an optional comment.

  5. 05

    Valid

    Approved and immediately visible to everyone authorised — with date and approver recorded.

  6. 06

    Review

    The system calculates the next review date and sends an automatic reminder before expiry.

If a document is rejected, the workflow stops and everyone involved is notified — once revised, the process restarts without any manual coordination.

Features

Everything you need for professional document control

Controlled approval process

Documents are approved according to a defined approval workflow. All decisions are stored in an audit-proof way.

Automatic review cycle

Every document is given a configurable review interval (6–24 months) and sends an automatic reminder before expiry.

Consultation process

Experts from other departments give feedback before approval — as evidence for audits.

Full traceability

All versions, approvers, reviewers and comments are stored with the document, without gaps.

Role-based permission concept

Clear separation of authors, approvers and readers. Temporary permissions are granted and revoked automatically.

Native SharePoint integration

No parallel system — the solution runs directly in SharePoint as an extension with ribbon buttons and web parts.

Controlled approval

Multi-stage approval workflow

Every document passes through a defined approval process before it becomes visible to employees — configurable per document type.

Multi-stage approval
One or more approvers — either all must agree or the first approval is sufficient. Configurable per document type.
Automatic task assignment
Approvers receive a task by email with a direct link — no system login required.
Audit-proof logging
Who decided what, and when — everything stored traceably in the version history.
Approval task
QM-001 · Workflow started
2 approvers
Completion condition: all approvals
AM
Anna Meier
Head of department
Approved
TB
Thomas Berger
Quality management
ApproveReject
Notification with direct link sent automatically

Always up to date

Automatic review cycle

Approved documents are checked for currency at regular intervals. The system manages the entire cycle — without manual follow-up.

Freely selectable review interval
Configurable per document (6, 12 or 24 months). The next review date is calculated automatically.
Automatic reminder
Shortly before expiry, those responsible receive an email — forgotten review dates are a thing of the past.
One-click review
If the document is still up to date, a single confirmation is enough — the next review date is reset immediately.
Review cycle
QM-001 · Major version 3.0
Active
92
days until review
Review interval12 months
Next review14/09/2026
ResponsibleA. Meier
Reminder 14 days before expiry

Expert feedback

Consultation as audit evidence

Before approval, experts from other departments can be asked for feedback — in parallel with and independently of the approval workflow.

Flexible invitations
Invite as many people as you like to the consultation. They receive temporary editing rights to the document.
Structured feedback
Consulted people can agree, or reject with a comment — clearly and traceably.
Evidence for audits
All feedback is stored with the document — as proof that the relevant parties were involved.
Consultation
QM-001 · Feedback requested
3 people
“Please provide your expert feedback before approval.”
SKSandra Keller✓ Agreed
MFMarco Frei✓ Agreed
PVPetra Vogelpending
All feedback is stored with the document in an audit-proof way.

Complete records

Metadata & version management

Every document carries structured metadata that the workflow fills in automatically. Manual entries are kept to the bare minimum.

Automatically filled metadata
Approved by, review date, scope, initials of everyone involved — all without manual upkeep.
SharePoint-native versioning
Major and minor versions are fully retained — audit-proof archiving with no extra effort.
Findable via SharePoint search
By title, document type, scope and more — no more searching through scattered drives.
Properties
QM-001 · Metadata
Approved byAM, TB
Approved on14/09/2025
Reviewed byA. Meier
Next review14/09/2026
ScopeEntire organisation
Document typePolicy
Version history: 3.0, 2.0, 1.0 — fully retained
Native integration

No parallel system. Everything in Microsoft 365.

A deliberate choice for native integration rather than an isolated solution — your data stays in your SharePoint environment, managed via your existing Azure AD groups.

No change of system

Employees work in the environment they already know. No learning curve, no acceptance issues.

One login for everything

Authentication via Azure Active Directory — no separate password, no additional system.

Your data stays with you

All documents and metadata reside in your SharePoint environment — no data in third-party systems.

Scalable

The module grows with your organisation. New departments or locations are easily added.

Seamless search

Documents can be found via SharePoint search — by title, type, scope and more.

Mobile use

Accessible from any browser and the SharePoint mobile app — on the go, too.

Central permission management

Managed via existing Azure AD groups — no parallel administration.

Audit-proof archiving

SharePoint stores all versions automatically — a complete history with no extra effort.

Compliance & certifications

The requirements are clear — we meet them

ISO 9001:2015

Quality management

Clause 7.5 requires documented information with evidence of creation, approval, change and distribution — fully covered.

ISO 13485:2016

Medical devices

Strict document control: versions, approvals, withdrawal of obsolete documents. The entire lifecycle is fully mapped.

GMP · FDA 21 CFR Part 11

Pharmaceutical industry

Electronic signatures and audit trails are mandatory. Every decision is logged with timestamp, user and comment.

SanaCERT · JACIE

Swiss healthcare

Accreditation standards require structured, traceable document control. Reference customer: Kantonsspital St. Gallen.

“We didn’t want yet another isolated solution. With SoftForge Controlled Documents we have a clean solution right inside SharePoint — our employees didn’t have to learn anything new.”
— User feedback, Kantonsspital St. Gallen (KSSG)
Who it’s for

Wherever documents have to be binding

Healthcare

Hospitals and clinics are subject to strict requirements for documenting processes and standards.

  • Work instructions & SOPs
  • Medical guidelines
  • QM documents
  • Forms & checklists
SanaCERT · JACIE · Swissmedic · ISO 13485

Pharma & industry

GMP-compliant documentation is not optional. The module delivers complete electronic evidence.

  • Test & work instructions
  • Production processes & SOPs
  • Batch records
  • Regulatory documents
ISO 9001 · GMP · FDA 21 CFR Part 11

Public administration & services

Even outside regulated industries, structured document control creates clarity and governance.

  • Directives & regulations
  • Organisation charts & concepts
  • Corporate policies
  • Compliance documents
Compliance · Audit readiness · Governance

FAQ

Frequently asked questions

01
What are “controlled documents” and why do we need a solution for them?
Controlled documents are documents that must be created, reviewed, approved and kept up to date according to a defined process — such as policies, SOPs or work instructions. SoftForge Controlled Documents automates exactly this lifecycle directly in Microsoft SharePoint: controlled approval, complete traceability, audit-proof archiving and structured review cycles. This way, employees always work with the current, valid version.
02
Do we need to introduce a new system or migrate data?
No. The solution is built as a native SharePoint extension and runs directly in your existing Microsoft 365 environment — with ribbon buttons and web parts. There is no parallel system, no separate sign-in and no data migration. All documents and metadata stay in your SharePoint.
03
Which standards and certifications are supported?
The module covers the requirements for documented information set out in ISO 9001, ISO 13485 and GMP / FDA 21 CFR Part 11, as well as the Swiss healthcare standards SanaCERT and JACIE. Every decision is logged in an audit-proof way with timestamp, user and comment — a complete audit trail at the push of a button.
04
Does the solution also work with SharePoint on-premises?
Yes. Controlled Documents is available both for SharePoint Online (Microsoft 365) and for SharePoint Server (SPSE) on-premises. SoftForge supports you whatever your IT strategy.
05
Where does our data stay?
Entirely within your own SharePoint environment. All documents, versions and metadata are stored in SharePoint lists and libraries — there is no external system and no data export to third-party solutions.
06
How quickly can the module be introduced?
Deployment is tenant-wide via the SharePoint app catalog — no manual activation per site. In practice, roll-out takes weeks rather than months. SoftForge supports you from requirements gathering through configuration to go-live.

Contact us

Ready for structured document control? We’ll show you the module in a live demo in your own SharePoint environment.

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