Change Control Management System (CCMS)
Automate, Approve & Track Every Change with Full Audit‑Trail and Compliance
Our services are delivered with years of experience and we are passionate about developing business
What Is a Change Control Management System?
A Change Control Management System (CCMS) is a digital solution that helps organisations capture, assess, approve, implement and track changes in a controlled and auditable fashion. It transforms ad‑hoc email and spreadsheet workflows into a standardised, traceable change lifecycle.
- Change request initiation (equipment, process, document, system)
- Impact & risk assessment across quality, cost, compliance
- Approval workflows with digital signatures
- Implementation tracking and task assignment
- Verification, closure and full audit trail
With Havteq’s Change Control Management System, you can digitise change requests, impact assessments, multi-level approvals, implementation tracking and verification in one platform. Gain visibility, ensure compliance and shorten cycle times.
The change control management system provides comprehensive reports to keep stakeholders or project stakeholders informed. This gives you greater control over your change process and plan, ultimately helping you save time and energy in the long run. Integrate seamlessly with our Non-Conformance Management Software to track quality issues arising from change implementations.
Why Industries Need Change Control Management System (CCMS)
When change control is manual, organisations face high risk and lost time. Some stats: up to 40% of change requests bypass formal approval, while audits cite missing change documentation in 30% of compliance failures.
Common Challenges:
- Changes executed without proper review or approval
- Disparate email and spreadsheet workflows with no audit trail
- No real‑time visibility of change status across sites
- Delayed approvals and lost deadlines
- Inadequate documentation for audits and regulatory inspections
How Havteq CCMS Fixes It
- With one central platform, Havteq CCMS ensures every change is logged, approved, tracked and archived — keeping you audit ready and in control.
For organizations working towards or maintaining FSSAI, ISO 22000, BRCGS, GFSI or FSMA compliance, Havteq CCMS becomes a central part of the quality management systm. Contact us for free trial. Read more How To Overcome Common Challenges Of Change Control In Your Company and Streamline Change Control with Management Software
Key Features of Havteq Change Control Management System
Change Request Creation & Intake Module
Allow users to easily raise change requests for processes, equipment, documents, software or supplier changes—all with custom forms, mandatory fields and attachments.
Impact Assessment & Risk Evaluation
Before any change is approved, teams perform cross‑functional assessments of quality, cost, safety and compliance. The system applies risk matrices (severity, likelihood, detectability) and highlights high‑impact changes.
Automated Approval Workflows
Route change requests through configurable paths with digital signatures, parallel/sequential approvals, automatic escalations and audit trail timestamps.
Implementation Planning & Task Assignment
- Automatic task creation post‑approval
- Assignment to responsible teams and users
- Due dates, reminders and escalations
- Link to documents, SOPs, training and equipment modifications
Verification, Validation & Closure
QA verifies results, uploads evidence, validates outcomes, then officially closes the change request—all logged in the system.
Complete Audit Trail & Version Control
Every action, user, timestamp, document version and change history is logged. Full traceability for regulatory inspections, ISO audits or internal reviews.
How Havteq Change Control Management System (CCMS) Works
Managing change in a regulated environment requires clarity, documentation, cross-functional collaboration and strict adherence to quality and compliance procedures. Havteq CCMS digitalizes the entire lifecycle, ensuring every change is logged, evaluated, approved, executed and verified with a complete audit trail. Below is the detailed end-to-end workflow followed within the system.
Change Request Submission
Any authorized user can initiate a change request from the web or mobile interface. The submission form captures all essential information:
- Type of change – process, equipment, document, software, supplier, packaging, engineering
- Reason for the change and problem statement
- Detailed description, risk indicators and supporting documents
- Priority (Low / Medium / High / Critical)
- Departments/locations impacted
- Proposed benefits and expected outcomes
This ensures all stakeholders start with clear, structured information—reducing ambiguity and rework.
Initial Screening & Categorization
The Change Control Coordinator or QA team reviews the submitted request and categorizes it:
- Minor – Limited impact, minimal change
- Major – Cross-functional impact requiring multiple approvals
- Critical – High risk, may impact compliance, safety or quality
Based on the categorization, the system automatically applies the appropriate workflow template and assigns reviewers.
Cross-Functional Impact Assessment
The heart of CCMS lies in evaluating all possible impacts before allowing any change. Havteq CCMS facilitates a structured impact assessment across:
- Quality impact – product quality, deviations, customer complaints
- Regulatory compliance – GMP, HACCP, ISO, 21 CFR Part 11
- Cost impact – resource utilization, raw material changes, OPEX
- Safety implications – plant safety, personnel safety
- Operational efficiency – production scheduling, equipment downtime
- Supply chain impact – vendor/supplier dependency, lead times
- Documentation impact – SOPs, work instructions, manuals, validation docs
The system automatically generates a Risk Priority Number (RPN) to guide decision-making.
Automated Multi-Level Approval Workflow
Once impact assessment is completed, the change request moves through a digitally driven approval workflow. Havteq CCMS supports:
- Sequential approvals
- Parallel approvals for cross-functional teams
- Role-based authorization & access control
- Configurable approval hierarchies (Engineering, QA, Production, R&D, IT, Supply Chain)
- Digital signatures compliant with 21 CFR Part 11
- Email & in-app notifications
- Automatic reminders and escalations for delayed approvals
Every approval is time-stamped and stored as part of the permanent audit trail.
Implementation Planning & Task Assignment
After approval, the system automatically converts the change request into an actionable plan. It generates:
- Task lists & sub-tasks
- Assigned responsibilities (RACI)
- Due dates, reminders & escalation logic
- Required resources (tools, manpower, documentation)
- Links to SOP revisions, training modules and related documentation
Team members update task progress directly in the system, enabling real-time transparency.
Execution & Real-Time Tracking
During implementation, each responsible department performs assigned actions and updates status. The system allows:
- Uploading implementation evidence (photos, reports, measurements, drawings)
- Capturing deviations or unexpected issues
- Triggering CAPA (Corrective Actions/Preventive Actions) if required
- Tracking dependencies between tasks
- Monitoring progress visually via dashboards
This ensures change execution remains aligned with the approved plan.
Verification, Validation & Effectiveness Check
Once implementation is complete, QA performs a detailed verification:
- Confirming the change was executed correctly
- Reviewing uploaded evidence
- Validating expected outcomes against actual results
- Ensuring no compliance or quality impact remains
- Performing effectiveness checks after a defined monitoring period
Any issues found can trigger rework, CAPA or corrective measures.
Final Closure & Audit-Ready Archiving
After successful verification and validation, the change request moves to closure. Havteq CCMS archives:
- Complete audit trail (who did what, when and why)
- Impact & risk assessment records
- Approvals & signatures
- Implementation tasks & evidence
- Linked CAPAs, deviations or documents
- Version history of related SOPs and attachments
This makes your organization 100% audit-ready for ISO, FDA, FSSC, HACCP, and internal audits.
With Havteq CCMS, your change management process becomes more predictable, compliant and data-driven. Every request follows a structured lifecycle, ensuring transparency, cross-functional accountability and continuous improvement across the organization.
Give wings to your business with an effective customized software
Benefits of Havteq Change Control Management System
| Benefit | Impact |
|---|---|
| Faster change cycle times | Shorten approval and implementation delays |
| Improved compliance | Maintain full audit trail and regulatory readiness |
| Reduced risks | Evaluate and mitigate risks before change approval |
| Better visibility | Dashboards for all stakeholders and locations |
| Standardised workflows | Consistent processes across teams and plants |
| Integrated quality management | Connect change control with CAPA and deviations |
Industries We Serve
Our quality management software is trusted across regulated and quality-critical industries
Pharmaceuticals & Life Sciences
Manage equipment, formulation, SOP & packaging changes—complying with 21 CFR Part 11 and GMP.
Food & Beverage Manufacturing
Track recipe, process and packaging changes; link to HACCP and allergen control workflows.
Chemicals & Specialty Materials
Control process modifications, chemical substitutions and equipment changes.
Cosmetics & Personal Care
Handle formulation changes and global regulatory updates.
Electronics & High‑Tech
Manage engineering change requests and multi‑site changes.
Frequently Asked Questions
Know more about Safety Management Software
What is a Change Control Management System (CCMS)?
A CCMS is a software solution that captures, evaluates, approves, implements, verifies and documents all organizational changes. It ensures every change follows a controlled workflow and remains compliant with regulatory standards such as GMP, ISO, HACCP and 21 CFR Part 11.
Who uses Havteq CCMS?
Havteq CCMS is used by QA teams, engineering teams, production managers, maintenance departments, regulatory professionals, R&D, IT teams and the Change Control Board (CCB) in regulated industries.
Can Havteq CCMS be customized for our internal workflows?
Yes. Workflows, forms, approval sequences, categories, risk matrices, statuses and user roles can be fully customized to match your organization’s SOPs and quality procedures.
Does CCMS help in risk and impact assessment?
Absolutely. Havteq CCMS includes a configurable risk assessment tool that evaluates severity, likelihood and detectability to calculate Risk Priority Number (RPN). It also supports cross-functional impact assessment across quality, safety, cost, compliance and operations.
Is Havteq CCMS compliant with regulatory standards?
Yes. Havteq CCMS is built to support compliance with GMP, ISO 9001, ISO 22000, FSSC 22000, HACCP, FDA 21 CFR Part 11, GAMP 5, and other quality management frameworks.
Does the system provide audit-trail and version control?
Yes. Every action—submission, review, approval, task update and closure—is time-stamped with user details. Document versioning and full audit trails ensure complete traceability during internal or external audits.
Is training required for using Havteq CCMS?
Minimal training is required. The platform is user-friendly and designed for technical and non-technical users. Havteq also provides onboarding, workshops and user guides.
