Solution · Regulatory Compliance

Make Regulatory Requirements Manageable

Standards, internal specifications, legislation, and corporate policies create massive requirement sets for regulated organizations. We help teams structure this complexity, make it searchable, and activate it for daily operations.

Starting Point

Compliance Is Not A Project—It Is Daily Business

GRC teams, quality managers, and regulated business units face the same challenge: an ever-growing list of requirements from very different sources that must be understood, implemented, and evidenced.

It is rarely just about external standards. Internal specifications, customer expectations, legal mandates, and policies all need to be managed—often without the resources such work would normally demand.

Fragmented Document Landscape

Standards, laws, and guidance spread across countless sources, hard to search and reconcile.

Keeping Pace With Change

When standards or mandates change, teams must quickly see what is different and what deliverables, processes, or controls are impacted.

Knowledge Transfer

New colleagues need months to absorb the relevant standards and procedures.

Disconnected Systems

Requirements live in one system, implementation artifacts in another—with little transparency between them.

Solutions

Core Compliance Use Cases in Operational Environments

Regulatory Research & Orientation

Quickly assess relevant requirements across documents.

Challenge: Regulatory requirements and internal policies are spread across many documents and systems. A consistent overview is often missing.

Solution: KogniLink semantically structures regulatory and internal content and makes it contextually searchable via natural language queries – traceable and across document boundaries.

Understanding Changes and Versions

Clearly identify what has changed – and what is affected.

Challenge: Policies and internal documents change regularly. What matters is not that something changed, but what changed – and with which operational impact.

Solution: KogniLink compares document versions in a structured way, detects changes, and transparently shows which content, processes, or evidence are affected.

Evidence and Audit Readiness

Reliably demonstrate coverage of regulatory requirements.

Challenge: Before audits or certifications, organizations must demonstrate that internal documents fully cover relevant requirements. Missing links quickly become a risk.

Solution: KogniLink links regulatory requirements to internal documents and makes dependencies transparent – providing a solid foundation for gap analysis and audit readiness.

All compliance use cases are built on KogniLink as the technical foundation. Access, sources, versions, and results are traceable, role-based, and designed for on-premise or private cloud environments.

Requirement Sources

What We Work With

Internal Standards

Organization-specific specifications

External Standards

ISO, DIN, EN, industry requirements

Laws & Regulations

Regulatory obligations

Customer Requirements

Specifications, requirement docs

Internal Policies

Corporate policies and governance

Operational Documents

SOPs, inspection plans, work instructions

Integration

Embedded In Your System Landscape

KogniLink does not replace existing systems; it connects and unlocks them. Integrating with your current infrastructure is a core element of our approach.

DMS

Document management

RMS

Requirements management

PLM

Product lifecycle

CCMS

Component content

Use Cases

Where This Creates Impact

R&D Onboarding

New engineers must master intricate standards and rulebooks. AI assistants answer expert questions instantly—grounded in your documentation.

Standards Updates

A standard changes. Version comparison highlights the delta; a gap analysis shows immediately which of your documents must be updated.

Audit Preparation

Ahead of external audits, teams gain rapid access to evidence and a systematic overview of coverage and gaps.

Internal Standard Management

Company standards evolve. Understand instantly how changes cascade into dependent documents and processes.

Regulatory Research

Which requirements apply to a new product? Search every relevant source through a single interface.

Certification Projects

Systematically verify whether every clause of a standard is covered by your internal documentation.

Experience

Eight Years Of Standards & Compliance Expertise

Since 2017 we have worked with standards organizations, regulated industries, and enterprises that take compliance seriously. That experience shapes everything we deliver.

Standards Bodies

Long-standing partner to DIN, collaboration with ISO and other European standards organizations, and core contributor to SMART STANDARDS.

Law Firms

Partnerships with specialized firms in regulatory affairs and compliance.

Certification Bodies

Extensive experience collaborating with leading certification organizations.

Technology

Powered By KogniLink

KogniLink is our enterprise AI platform for organizations where traceability and data sovereignty are non-negotiable.

On-Prem Or Private Cloud

Your data stays inside your infrastructure.

Traceable Outcomes

Every answer links back to the originating documents.

Enterprise Security

Granular roles and permissions, SSO, and audit trails.

Built For Regulated Environments

Designed for compliance-critical functions and documentation.

Learn More About KogniLink

Who It's For

This Solution Fits When…

You manage complex rulebooks—standards, legislation, and internal policies

Version comparisons are manual and resource intensive

New employees need months to get productive

Audits regularly absorb scarce resources

You require explainable solutions—not black boxes

Data sovereignty is non-negotiable

Let's Discuss Your Compliance Challenge

A no-obligation conversation about your situation, requirement sources, and potential next steps.