🛡️ Designed for GMP & GxP controlled workflows

Guided document control, quality workflows and contextual AI support in one place.

From guided SOP authoring and document readiness to controlled forms, executed records, training, Change Control and audit review — SOPManagerPRO connects the quality lifecycle and adds a context-aware AI Guide that can explain the current page, identify workflow attention items and guide users toward their next permitted step.

Start Free Explore the Platform
GUIDED
SOP Authoring & Readiness
FORMS
Controlled & Executed Records
AI GUIDE
Contextual Workflow Support
Quality & Compliance Dashboard
Illustrative demo UI
Illustrative quality and compliance dashboard for a demo pharmaceutical company
Quality & Compliance DashboardExecutive overview with document review queue, quality alerts, compliance status and training performance for a demo pharma workspace.

Illustrative product previews using realistic demo data for a fictional pharmaceutical workspace. SOPManagerPRO provides configurable controls that support regulated workflows; intended-use validation, configuration and compliance remain organisation responsibilities.

AI GuideWorkflow CheckGuided GMP BuilderDocument ReadinessMaster Document IndexControlled FormsExecuted RecordsAI Governance
Designed to support regulated quality systems

Controlled quality workflows. Designed for efficiency.

GMP / GxP

Controlled procedures, approvals and evidence.

ALCOA+

Traceable data-integrity controls and auditability.

PIC/S

Quality-system workflows oriented to PIC/S guidance.

Annex 11

Governance for computerised systems and records.

E-Signatures

Secure, traceable approvals with re-authentication.

Supports configurable quality-system workflows. Suitability, configuration and validation remain dependent on intended use and applicable regulatory requirements.
Industries

Built for regulated and process-driven organisations.

SOPManagerPRO is industry-agnostic at its core. If your organisation needs controlled procedures, approvals, training, forms, executed records and traceable evidence, the platform can be configured around your quality system.

⚕

Pharmaceuticals & Life Sciences

Document and quality workflows for regulated medicinal-product and life-science operations.

Pharmaceutical ManufacturingAPI / Drug SubstanceBiotechnologyBiologicsVaccinesCell & Gene TherapyCDMO / CMOCRO / Clinical ResearchGMP WarehousingVeterinary MedicinesCompounding Operations
✣

Medical Cannabis & Cannabinoids

Suitable for licensed cannabis businesses that need controlled SOPs, training, change control and traceable records.

GACP CultivationGMP ManufacturingProcessing & ExtractionPackagingQuality ControlAnalytical LaboratoriesWarehousingLicensed DistributionResearch & DevelopmentSeed / Genetics Operations
✚

Medical Devices, Diagnostics & Healthcare

Controlled procedures and records for healthcare-product and clinical environments.

Medical DevicesIVD / DiagnosticsClinical LaboratoriesTesting LaboratoriesHospitals & ClinicsBlood / Tissue / Cell BanksSterile ProcessingHealthcare Support ServicesCalibration Services
Medical Cannabis & Cannabinoids · 2 of 8
Flexible by design. Industry suitability depends on your intended use, configuration, validation approach and the regulations or standards applicable to your organisation. SOPManagerPRO supports controlled workflows; it does not replace your Quality Unit or provide regulatory certification.
Platform Capabilities

From controlled instructions to executed evidence.

A connected quality workspace for guided authoring, controlled records, training, governance and traceable evidence.

▦

Document Control & Master Register

The colour-coded Master Documentation Index is the default controlled-document view, with owner, revision, lifecycle, effective/review dates, training, distribution and health indicators.

◎

Guided GMP Builder & Readiness

Step-by-step authoring guidance, document-type prompts and a formal readiness gate before Draft content enters controlled review.

✓

Compliance & Executed Records

Version-bound blank forms and checklists with attributable entries, evidence hashes, completion signatures, independent verification and append-only corrections.

✍

e-Signatures & Approval Routes

Reviewed, Approved and Authorized signature meanings, re-authentication, configurable segregation of duties and controlled lifecycle transitions.

🎓

Training & Competency

Trigger training from Effective SOPs, assign by group, track acknowledgements, approve assessments and monitor completion or overdue training.

↻

Change Control, CAPA & Deviations

Assess impact, link quality events to controlled revisions, route approvals, manage implementation tasks and record effectiveness checks.

📊

GMP Quality Dashboard

Surface overdue document reviews, training, copy recalls, quality events, audit/access review status, system reviews and executed-record attention.

≡

Audit Trail & Access Reviews

Before/after audit evidence, formal signed Audit Trail Reviews and periodic User Access Reviews with least-privilege decisions.

⌘

Computerised Systems & Continuity

Annex 11-oriented system inventory, IT supplier oversight, validation status, backup verification, restore tests and business-continuity evidence.

✦

Contextual AI Guide & Governance

Page-aware guidance can explain the current workspace, check deterministic workflow attention items and suggest permitted next steps, alongside AI-assisted SOP import, analysis, comparison and quiz drafting under human review.

⇢

Distribution, PDFs & Watermarks

Professional controlled PDFs, QR verification, Master/Controlled/Uncontrolled/Electronic distribution, copy numbering, watermarks and recall control.

🔐

ISO Assurance & GxP Governance

Phase-based ISO assurance, industry/GxP profiles, risk and evidence registers, controlled Phase 1 policy templates, scope definition and launch-readiness governance.

Contextual AI Support

AI guidance that understands where the user is in SOPManagerPRO.

The AI Guide is available across the authenticated application. It can explain the current workspace, turn application facts into understandable guidance, run deterministic workflow checks and point users toward their next permitted action. The controlled workflow remains governed by SOPManagerPRO rules and authorised human decisions.

EXPLAIN THIS PAGEContextual product help without leaving the current task.
CHECK THIS WORKFLOWApplication-derived blockers and attention items—not an AI compliance judgement.
WHAT NEXT?Role-aware navigation toward permitted next steps, without signing or approving for the user.
✦
SOPManagerPRO AI GuideContext-aware workflow guidance
Current contextControlled Document · Draft
ⓘ

Explain this pageUnderstand the workspace and its controls.

✓

Check this workflowReview deterministic blockers and attention items.

→

What should I do next?See permitted next steps based on current workflow state.

Human-controlled by design. The AI Guide cannot approve, authorize, sign, release, verify or certify controlled work. Optional Claude-assisted questions can be governed separately by each organisation.
Assurance & Governance

From controlled SOPs to an evidence-backed assurance programme.

SOPManagerPRO now connects ISO readiness, privacy/continuity, industry profiles and pharmaceutical GxP mappings to the same controlled documents, risks, audits, CAPA and evidence used by the quality system.

Phase 1ISO/IEC 27001 + ISO 9001
Phase 2Privacy, continuity & cloud
Phase 3Product-framework mapping
Phase 4Industry & GxP profiles

Ready to strengthen document and record control?

Start with up to 15 controlled documents free and scale as your quality-system workflows grow.

Start Free
SOPManagerPRO in Your Environment

One governed quality workspace. Adapted to the way your company operates.

Whether you manufacture medicines, cultivate medical cannabis, run a laboratory, produce food, manage industrial operations or control distributed sites, SOPManagerPRO connects procedures, approvals, training, records and quality evidence in one traceable workflow.

Pharma & Life SciencesMedical CannabisDevices & LaboratoriesFood & Consumer HealthManufacturingEnergy & Logistics
Illustrative SOPManagerPRO quality and compliance dashboard
Quality & Compliance DashboardSee document, training, quality-event and governance attention points from one controlled workspace.
Illustrative SOPManagerPRO Master Document Index
Master Document IndexCurrent lifecycle, owner, revision, review and training status at a glance.
Illustrative SOPManagerPRO training and qualifications dashboard
Training & QualificationsConnect Effective SOPs to accountable learning and competency evidence.
Different industries. The same control problem.

Critical procedures should not live in disconnected files, inboxes and spreadsheets.

Every controlled environment has its own terminology, standards and risks, but the operational challenge is remarkably similar: people need the correct instruction, the correct version, at the correct time — and the organisation needs evidence that review, approval, training, execution and follow-up actually happened.

SOPManagerPRO provides a configurable backbone for that lifecycle. Your organisation defines the procedures, roles, approval routes, validation approach and applicable standards; the platform helps keep the resulting work structured, attributable and visible.

Control the instructionCreate, revise, review, approve, release and periodically review controlled documents.
Control the executionUse governed forms, checklists, distribution and training to connect instructions with evidence.
Control the follow-upLink quality events, change control, audit review and management visibility back to the controlled system.
Industry Applications

How SOPManagerPRO can support different operating environments.

These examples show how the same platform capabilities can be configured around different processes without pretending that every industry works the same way.

Illustrative Master Document Index used for pharmaceutical and life-science document control
A governed document register helps Quality teams see what is Effective, what is due for review and what still needs action.
Pharmaceuticals & Life Sciences

Connect the pharmaceutical quality system from document creation through evidence.

For GMP/GxP environments, SOPManagerPRO can centralise controlled procedures and supporting records while retaining the review, approval, training and audit evidence expected from a governed quality process.

Typical workflows
  • SOPs, policies, specifications and protocols
  • Review, approval, authorization and effective dates
  • Periodic review and document-health oversight
  • Controlled distribution and verified PDFs
Quality connections
  • Training triggered from Effective procedures
  • Change Control, CAPA and deviations
  • Audit Trail and formal access reviews
  • Computerised-system and continuity evidence
GMP / GxPPIC/S-oriented workflowsAnnex 11-oriented governanceALCOA+ principles
Illustrative SOP library used for medical cannabis quality documentation
Cultivation, processing, quality and support teams can work from the same controlled SOP library while keeping responsibilities separated.
Medical Cannabis & Cannabinoids

Bridge GACP cultivation, GMP operations and quality oversight.

Licensed cannabis organisations often span cultivation, post-harvest, processing, QC, packaging and warehousing. SOPManagerPRO helps keep the procedures and competence requirements for those environments under one controlled lifecycle.

Operational use
  • Cultivation, sanitation and environmental procedures
  • Harvest, drying, processing and packaging instructions
  • Sampling, laboratory and release-support procedures
  • Equipment, cleaning and maintenance instructions
Quality use
  • Role- or department-based training
  • Deviations, CAPA and controlled change
  • Distribution of current approved procedures
  • Periodic review and inspection-readiness dashboards
GACPGMP ManufacturingQuality ControlLicensed Distribution
Illustrative controlled forms dashboard for laboratory and medical-device workflows
Version-controlled blank forms can become attributable executed records tied to the exact approved source version.
Medical Devices, Diagnostics & Laboratories

Turn procedures, methods and forms into a traceable operating system.

Laboratories and device organisations depend on controlled methods, calibration, equipment records, forms and competent personnel. SOPManagerPRO helps connect those elements without forcing teams to manage each record stream in isolation.

Typical workflows
  • Test methods, work instructions and quality procedures
  • Calibration and equipment-related forms
  • Sample-handling and controlled checklist execution
  • Documented review and electronic approval
Quality connections
  • Training matrices and assessment evidence
  • Nonconformance / deviation follow-up
  • Revision impact and change control
  • Audit Trail and access governance
ISO 13485 environmentsISO 17025 laboratoriesIVD / DiagnosticsCalibration Services
Illustrative training matrix for food, nutraceutical and consumer-health operations
Training visibility helps supervisors see who has acknowledged new or revised procedures and where competency follow-up is needed.
Food, Nutraceuticals, Cosmetics & Agriculture

Standardise hygiene, production and quality procedures across operational teams.

Where consistency, sanitation, traceability and staff training matter, SOPManagerPRO can provide a controlled home for procedures and the records that show those procedures were communicated and followed.

Typical workflows
  • Hygiene, sanitation and cleaning procedures
  • Production, packing and warehouse instructions
  • Allergen / contamination-control procedures
  • Maintenance and inspection checklists
People & evidence
  • Role-based training assignment
  • Acknowledgements and approved assessments
  • Controlled forms and record completeness
  • Corrective action and revision follow-up
Food Safety SupportNutraceuticalsCosmeticsPackhouses & Agriculture
Illustrative change control and CAPA dashboard for industrial manufacturing
Controlled change links proposed modifications to affected documents, implementation tasks, approvals and effectiveness checks.
Industrial & Advanced Manufacturing

Keep production, maintenance and engineering instructions aligned when the process changes.

Manufacturing teams need more than a document repository. They need a way to control revisions, communicate new instructions, assess change impact and retain evidence that the workforce moved to the new process.

Operational use
  • Work instructions and production SOPs
  • Maintenance and equipment procedures
  • Inspection / in-process checklists
  • Controlled copies at points of use
Change & quality
  • Impact assessment before implementation
  • Linked CAPA and deviation records
  • Training impact from revised instructions
  • Effectiveness checks after change
ISO 9001 QMS supportEngineeringAutomotiveContract Manufacturing
Illustrative users and permissions dashboard for distributed operations
Role-based access and periodic access review are especially valuable where employees, contractors and multiple operational functions share one quality workspace.
Energy, Utilities, Logistics & Controlled Services

Distribute controlled procedures across sites, shifts and service teams without losing governance.

Distributed operations need current procedures to reach the right people while management retains visibility over access, training, acknowledgement, document revision and follow-up actions.

Typical workflows
  • Site and safety-critical operating procedures
  • Warehouse, cold-chain and logistics instructions
  • Contractor / service-provider procedures
  • Controlled electronic or printed distribution
Governance
  • Role-based permissions and 2FA support
  • User lifecycle and periodic access review
  • Training acknowledgement across teams
  • Audit-ready change and activity history
Power & UtilitiesWater & WastewaterWarehousing3PL / Controlled Services
Connected Lifecycle

One governed path from instruction to evidence.

The value is not a single feature. It is the connection between the steps, so a new or revised procedure can move through control, release, training, execution and follow-up without creating another disconnected record trail.

01AuthorStructured templates, Guided Builder and readiness support.
02ReviewDefined reviewers, comments and retained revision evidence.
03ApproveRe-authenticated electronic signatures and approval meaning.
04ReleaseEffective versions, controlled PDFs, QR verification and distribution.
05TrainAssignments, acknowledgements, assessments and completion tracking.
06ExecuteControlled forms, checklists and attributable executed records.
07ReviewAudit Trail reviews, access reviews, dashboards and periodic review.
08ImproveChange Control, CAPA, deviations and effectiveness follow-up.
Value Across the Organisation

Different teams see the same controlled truth.

SOPManagerPRO gives each function the information it needs while keeping the underlying document and evidence lifecycle connected.

QA

Quality & Compliance

See review queues, overdue actions, document health, training gaps, quality events and audit evidence without rebuilding the picture manually.

OP

Operations

Give teams controlled access to current Effective procedures and forms, reducing uncertainty over which instruction should be followed.

TR

Training & People

Connect new or revised SOPs to training groups, acknowledgements, approved assessments and competency visibility.

EN

Engineering & Maintenance

Control equipment and maintenance instructions, link changes to affected documents and retain evidence of implementation follow-up.

IT

IT & System Owners

Support governed user access, 2FA, access reviews, computerised-system inventories, backup evidence and continuity reviews.

EX

Management & Auditors

Use dashboards and traceable records to understand outstanding risk and inspect the history behind a document, signature, training action or change.

Platform Capabilities

More than an SOP library.

A connected set of document-control, training, record, quality and governance tools for organisations that need repeatable processes and traceable evidence.

01

Master Document Index

Central control of document number, owner, revision, lifecycle, effective/review dates, training, distribution and health indicators.

02

Guided Authoring & Readiness

Structured authoring support, document-type prompts and a readiness gate before controlled review.

03

Approval Routes & e-Signatures

Reviewed, Approved and Authorized signature meanings with re-authentication and configurable segregation of duties.

04

Controlled Forms & Records

Version-bound forms and checklists with attributable entries, evidence hashes, completion signatures and controlled corrections.

05

Training & Competency

Training groups, SOP-triggered assignments, acknowledgements, approved assessments and completion / overdue visibility.

06

Distribution, PDFs & Watermarks

Controlled, uncontrolled and electronic distribution with numbering, configurable watermarks, QR verification and recall tracking.

07

Change Control, CAPA & Deviations

Assess impact, link affected controlled documents, route approvals, manage tasks and record effectiveness follow-up.

08

Audit Trail & Access Reviews

Before/after activity evidence plus formal Audit Trail Reviews and periodic User Access Reviews.

09

Quality Dashboards

Surface overdue reviews, training, quality events, copy recalls and governance actions that need attention.

10

Computerised Systems & Continuity

Annex 11-oriented system inventory, supplier oversight, validation status, backup verification and restore-test evidence.

11

Contextual AI Guide & Governance

Explain the current page, check workflow attention items and guide users toward permitted next steps, with optional AI-assisted questions plus existing SOP analysis, comparison and quiz drafting under human review.

12

Security & Role Governance

Organisation-specific workspaces, role-based access, 2FA support, user lifecycle controls and periodic governance review.

See how SOPManagerPRO fits your environment.

Tell us how your company operates and we can show how document control, training, executed records and quality governance can be configured around your workflow.

Request a Demo Start Free

SOPManagerPRO provides configurable software controls that can support regulated and quality-managed workflows. Suitability, configuration, validation, regulatory interpretation and compliance remain the responsibility of each organisation according to its intended use and applicable requirements.

Transparent Plans

Start small. Scale your controlled system.

Choose an SOP entitlement that matches your organisation today, then expand without rebuilding your controlled-document history. Platform capability does not replace your own validation, procedures or regulatory responsibilities.

Monthly Annual Save over 20%

Professional is US$49 billed monthly. Switch to annual to see the US$39/month equivalent and the full annual charge.

Free
For small teams evaluating controlled SOP and quality workflows.
$0/mo
No subscription charge
Up to 15 active SOPs
  • ✓Create and manage controlled SOPs
  • ✓Controlled review / approval lifecycle
  • ✓Version history and document traceability
  • ✓Distribution, acknowledgement and training workflows
  • ✓Explore configured platform quality modules
  • ✓Self-guided organisation setup
Start Free A practical way to evaluate SOPManagerPRO with real internal procedures.
Most Popular
Professional
For growing quality teams that need a larger controlled-document estate.
$49/mo
US$49 billed monthly per organisation
Up to 100 active SOPs
  • ✓Everything available to the Free workspace
  • ✓100-active-SOP entitlement for broader operational use
  • ✓Suitable for QA, operations, training and support functions
  • ✓Priority support pathway
  • ✓Plan and implementation guidance for growing teams
  • ✓Upgrade without recreating controlled-document history
Choose Professional Monthly activation: US$49 per organisation.
Enterprise
For larger, complex or high-volume regulated and quality-managed organisations.
Custom
Commercial and service terms scoped with your organisation
Unlimited active SOP entitlement
  • ✓Everything in Professional
  • ✓Unlimited active SOP entitlement
  • ✓Organisation-specific rollout planning
  • ✓Priority onboarding and advanced support options
  • ✓Validation-support and supplier-assurance discussion
  • ✓Custom commercial and service terms
Request Enterprise Demo We scope requirements before confirming Enterprise commercial terms.
Plan comparisonFreeProfessionalEnterprise
Active SOP entitlement15100Unlimited
Controlled document lifecycleIncludedIncludedIncluded
Distribution & acknowledgementsIncludedIncludedIncluded
Training workflowsIncludedIncludedIncluded
Configured quality / governance modulesAvailableAvailableAvailable
Contextual AI Guide & AI-assisted functionsWhen enabledWhen enabledWhen enabled
Onboarding approachSelf-guidedGuided supportPriority / scoped
Support routeStandardPriorityAdvanced / agreed
Commercial modelFreeMonthly or annualCustom

Plan enforcement currently centres on the number of non-archived active SOPs in the organisation. Some capabilities require organisation configuration, appropriate permissions, enabled integrations or customer-specific validation before regulated production use.

Implementation & Onboarding

A controlled rollout, not just another login.

SOPManagerPRO can be introduced gradually. Start with organisation setup and document control, then configure training, quality workflows and governance around your intended use.

1

Structure the workspace

Confirm organisation settings, roles, departments, numbering, document ownership, approval routes and security decisions before broad use.

2

Move controlled work into the system

Import or author representative procedures, configure distribution and training, then test the workflows that matter to your own operating environment.

3

Accept and govern the configured system

For regulated use, perform organisation-specific risk assessment, testing, validation/acceptance, change control and ongoing governance appropriate to intended use.

Pricing FAQ

Common questions before you start.

Is the Free plan really free?

Yes. The Free plan is intended for organisations managing up to 15 active, non-archived SOPs. It is a useful way to evaluate your SOPManagerPRO workflow before moving to a paid entitlement.

How does Professional annual billing work?

Professional is US$49 per organisation when billed monthly. The annual option is US$468 billed for the year, which is equivalent to US$39 per month and saves a little over 20% compared with twelve monthly payments.

What counts toward the SOP limit?

The current entitlement check counts SOP records in the organisation that are not archived. Controlled history is retained; plan limits are not intended to erase historical records.

Will upgrading make us recreate our SOPs?

No. The subscription model is designed to change the organisation's SOP entitlement without replacing its controlled-document history. Paid activation should be confirmed before relying on the higher limit.

Does SOPManagerPRO make our company GMP, GxP or ISO compliant?

No. SOPManagerPRO provides software controls that can support regulated and quality-managed workflows. Your organisation remains responsible for intended use, validation, configuration, procedures, training, regulatory interpretation, records and compliance decisions.

When should we speak to you instead of registering directly?

If you expect more than 100 active SOPs, have a complex rollout, need supplier/validation-support information, or want to review how the platform fits your regulated environment, request an Enterprise or product demo first.

Regulatory positioning: References to GMP, GxP, GACP, ISO, PIC/S, 21 CFR Part 11 or related frameworks describe intended workflow support and design context. They are not a certification claim and do not establish conformity for a customer's configured instance.
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Request a product demo, discuss pricing and onboarding, or ask how SOPManagerPRO could support your controlled-document and quality workflows.

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