Compliance & Digital Governance

Compliance Starts With Controlled Information

From ISO standards and QHSE requirements to information security, data governance and AI, organizations need more than policies. They need controlled processes, reliable records and evidence that can be found when it matters.

DocumentsDataWorkflowsAssetsPeople
↓
Controlled→Traceable→Audit Ready

Turn Compliance Requirements Into Controlled Digital Processes

Compliance requirements often span multiple departments, systems and sources of information. Policies may sit in document repositories, maintenance records in spreadsheets, approvals in email, permits on paper and operational evidence across disconnected systems.

EDMS Consultants helps organizations connect these processes through intelligent information management, document control, workflow automation, asset management and digital governance solutions.

Documents→Data→Workflows→Assets→People→Controlled Information

Controlled Information

Ensure teams access the right and latest approved information.

Traceable Processes

Maintain visibility of approvals, changes, activities and decisions.

Audit Readiness

Make supporting evidence easier to locate, verify and present.

Continuous Improvement

Use structured information and operational data to identify gaps and improve processes.

ISO & Regulatory Standards

Standards & Frameworks We Can Help Support

Every framework below has its own documentation, evidence and audit requirements. Here is how EDMS Consultants' solutions can help operationalize the controls behind them.

ISO 9001 — Quality Management

Quality management systems, documented information, process control, corrective actions and continual improvement.

  • Controlled procedures & work instructions
  • Version control & approval workflows
  • Corrective and preventive action records
  • Audit trails & evidence retrieval
M-Files · Fiix

ISO 14001 — Environmental Management

Environmental management systems, operational controls, monitoring records and continual improvement.

  • Environmental procedures & policies
  • Inspection documentation
  • Controlled forms & monitoring records
  • Retention & document lifecycle
M-Files

ISO 45001 — Occupational Health & Safety

OHS management, risk controls, inspections, incident-related records and evidence.

  • HSE policies, procedures & risk assessments
  • Inspection & training records
  • Incident documentation & corrective actions
  • Controlled forms & audit evidence
M-Files · IntelliPERMIT · Fiix

ISO 27001 — Information Security

Information security management, access control, risk management and policy governance.

  • Role-based access & classification
  • Audit trails & information lifecycle
  • Policy management & secure collaboration
  • Retention controls
M-Files

ISO 22301 — Business Continuity

Business continuity management, documented plans, recovery procedures and evidence.

  • Business continuity & recovery plans
  • Emergency documentation
  • Controlled versions & approval workflows
  • Access to critical information
M-Files

ISO 55001 — Asset Management

Asset management systems, maintenance planning, lifecycle management and performance.

  • Asset registers & maintenance records
  • Preventive & corrective maintenance
  • Inspection & calibration records
  • Asset-related documentation
Fiix · M-Files

ISO 13485 — Medical Devices Quality Management

Quality management and controlled documentation for medical device organizations — controlled documents, SOPs, quality records, approval workflows, version control, audit trails and evidence retrieval.

M-Files

Sector-specific regulatory requirements must be assessed according to the organization's jurisdiction and applicable medical-device regulations.

QHSE & Operations

From QHSE Documentation to Operational Evidence

Compliance is not limited to policies. Organizations also need to manage risk assessments, method statements, permit documentation, inspection records, safety procedures, training records, incident reports, corrective actions, equipment records, maintenance history, environmental records and audit findings.

Policy→Procedure→Work Activity→Evidence→Review→Corrective Action→Audit

M-Files

Document control and governance for QHSE policies, procedures and records.

IntelliPERMIT

Permit-to-work and operational safety process management.

Fiix

Asset maintenance, inspection and maintenance evidence.

Data Privacy & Information Governance

Compliance Extends Beyond ISO

Organizations increasingly need to manage information according to privacy, security, retention and governance requirements — covering personal data, sensitive business information, information access, retention, records lifecycle, secure sharing, data classification, audit trails and information ownership.

Personal & Business Data→Classification→Access & Retention Controls→Audit Trail

Relevant Regulatory Areas

  • Malaysia Personal Data Protection Act (PDPA)
  • GDPR, where applicable to organizations operating in or serving the European market
  • Industry-specific data protection requirements

How Our Solutions Can Help

M-Files can provide supporting controls around information classification, access, retention, lifecycle and traceability. It does not itself guarantee legal compliance with privacy regulations,  that depends on an organization's own policies and processes.

AI Governance & Digital Transformation

Preparing Your Information for AI

AI transformation depends on the quality, structure, accessibility and governance of organizational information, reliable source information, document classification, metadata, information ownership, version control, access controls, data governance, human oversight and auditability.

Unstructured Information→Governed Information→Contextual Knowledge→AI→Trusted Decisions

AI is only as reliable as the information and governance behind it.

Across our portfolio, AI capabilities are built into the solutions that manage the information they act on: M-Files Aino for governed enterprise content, Nuix AI-driven data analysis for investigation and eDiscovery, and DocuSign AI Contract Agents for agreement review. Each works within its own domain, with guardrails, controlled information and permissions in place. These capabilities support responsible AI use; they do not independently guarantee compliance with emerging AI regulations.

Solution Orientation

How Our Solutions Support Compliance

A high-level orientation to where each solution contributes across document control, workflows, assets and evidence — not a claim that any single feature directly satisfies a specific standard's requirement.

M-Files

  • Document control & version management
  • Approval workflows & audit trails
  • Records, retention & access control
  • AI-assisted information discovery

Fiix

  • Asset registers & maintenance history
  • Preventive & corrective work orders
  • Inspection & calibration evidence
  • Maintenance audit trails

Maintwiz

  • CMMS asset & maintenance records
  • Digital permit-to-work integration
  • Approval workflows
  • Maintenance audit trails

IntelliPERMIT

  • Permit-to-work management
  • Operational safety workflows
  • Approval & sign-off trails

Wrench

  • Engineering document control
  • Drawings, transmittals & vendor packages
  • Project approval workflows
  • Records & retention

SmartShare

  • Folder-based document control
  • Version management
  • Records & retention

DocuSign

  • Digital signatures
  • Approval workflows
  • Signing audit trails

Nuix

  • eDiscovery & investigation
  • Data audit trails
  • AI-assisted information discovery
Industries

Compliance Across Regulated Industries

Oil & Gas

  • QHSE
  • Engineering documentation
  • Permit management
  • Maintenance records
  • Project documentation & audit evidence
M-Files · IntelliPERMIT · Fiix

Manufacturing

  • ISO 9001, 14001, 45001
  • Quality records
  • Maintenance & calibration
  • SOPs
M-Files · Fiix

Engineering & EPCM

  • Document control
  • Drawings & transmittals
  • Vendor documentation
  • Project records & approval workflows
M-Files · Wrench

Utilities & Infrastructure

  • Asset management
  • Maintenance
  • Operational procedures
  • Compliance documentation & inspection records
Fiix · M-Files

Finance & Professional Services

  • Information governance
  • Records management
  • Contracts & approvals
  • Audit trails & data protection
M-Files · DocuSign

Healthcare / Life Sciences

  • Controlled documentation
  • Quality records
  • SOPs
  • Audit evidence & regulatory documentation
M-Files
Compliance Journey

From Compliance Requirement to Audit-Ready Evidence

1

Identify

Understand applicable standards, regulations and organizational requirements.

→
2

Structure

Classify documents, records, assets, responsibilities and processes.

→
3

Control

Apply permissions, version control, approval workflows and lifecycle rules.

→
4

Execute

Digitize operational workflows, maintenance activities, permits and approvals.

→
5

Track

Maintain audit trails, records and evidence.

→
6

Improve

Use reporting, analytics and continuous improvement processes to identify gaps.

Case Studies

Compliance in Practice

Frequently Asked Questions

Does ISO 9001 require an EDMS?

No. ISO 9001 does not require a specific software system. It requires organizations to control documented information and maintain appropriate evidence. An EDMS can help operationalize these controls.

Can M-Files make my organization ISO compliant?

No software automatically makes an organization compliant. M-Files can support document control, approvals, version management, audit trails, access control and information lifecycle management that may support an organization's compliance framework.

Which ISO standards can an EDMS support?

Depending on the organization's processes and requirements, an EDMS can support ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 22301, ISO 55001 and other standards.

Can Fiix support ISO compliance?

Fiix can support relevant operational and asset-management requirements through maintenance records, asset history, preventive maintenance, inspections, work orders and maintenance evidence.

Can your solutions support QHSE?

M-Files supports QHSE document control and governance, IntelliPERMIT supports permit-to-work and operational safety processes, and Fiix supports asset maintenance and inspection evidence — together covering the QHSE documentation and evidence lifecycle.

Can you help with audit readiness?

Yes. Controlled information, audit trails, evidence retrieval and workflow visibility can support audit preparation and make supporting evidence easier to locate, verify and present.

Do your solutions support Malaysian regulatory requirements?

Our solutions can support the digital management of documents, records, workflows and evidence associated with applicable Malaysian requirements. Legal applicability should be assessed against the organization's specific circumstances.

Can your solutions support AI governance?

Our solutions support information governance through metadata, access controls, structured knowledge and auditability — foundations that support the responsible use of AI.

Do I need to migrate all my documents?

Not necessarily. M-Files can support different information-management approaches and integrations depending on the organization's existing environment.

Is Your Organization Ready for the Next Audit?

Whether you are strengthening ISO controls, improving QHSE processes, preparing for AI adoption or modernizing document and asset management, we can help you identify where digital solutions can strengthen your compliance and governance processes.

EDMS Consultants provides technology and consulting solutions that support compliance, governance and audit readiness. Our solutions do not constitute certification or legal advice, and compliance ultimately depends on an organization's policies, processes, implementation and applicable regulatory requirements.

Logo