Control Every Change. Stay Compliant. Always.

How ChangeM – Change Management Software by goPLIMS gives regulated teams a formal, digitally signed, and fully traceable platform to initiate, approve, and close every change — from first request to verified closure.

What is ChangeM?

ChangeM is a centralised, cloud-based change management platform that provides a consistent and systematic approach to formally managing all changes throughout the project and work management lifecycle. From initiation through evaluation, pre-approval, execution, and post-approval, ChangeM ensures every change is documented, assigned, tracked, and closed with full compliance and traceability.

Eliminating the errors, miscommunication, and uncontrolled change that plague email-based processes, ChangeM brings every stakeholder into a single governed workflow. Critically, the module is fully integrated with electronic signature and email routing for sequenced, compliant approvals — built for regulated environments where governance is non-negotiable.

Change Lifecycle — End to End

Initiation → Evaluation → Pre-Approval → Execution → Post-Approval → Close-Out

Learn more about ChangeM

What You Can Do with ChangeM

ChangeM replaces fragmented, email-based change processes with a unified digital workflow — giving every stakeholder real-time visibility and a clear, compliant record from first request to verified closure.

Centralised Change Management

Initiate, evaluate, and formally manage every change in one platform — no scattered emails or disconnected approval chains.

Electronic Signature Workflows

Route changes through structured pre- and post-approval workflows with sequenced digital signatures and full email routing.

Compliant Digital Approvals

Collaborate with fully compliant electronic signatures — keeping every approval in a secure, auditable, and legally defensible record.

Documentation & Attachments

Attach all supporting documentation and deliverables directly to each change record — everything in one place, always accessible.

Real-Time Dashboards & Reports

Visualise change status, outstanding tasks, and due dates at a glance — giving project managers full visibility across all active changes.

Draft Until Complete

Keep incomplete change requests in Draft status until they are fully prepared and compliant — preventing premature submission into approval workflows.

Compliant Approval Workflows

ChangeM’s most powerful and distinctive feature is its built-in digital signature capability — purpose-built for regulated and compliance-driven environments, and fully aligned with 21 CFR Part 11 requirements. This is what separates ChangeM from generic workflow tools.

21 CFR Part 11 Digital Signatures

Sequence and collaborate electronic signatures for pre-approvals and post-approvals — in the right order, every time

Automatically log all activities, approvals, and documentation for full, unbroken traceability

Effortlessly demonstrate compliance with industry standards and audit requirements at any moment

Keep incomplete change requests in Draft until they are complete and fully compliant before submission

Maintain a secure, unbroken audit trail from change initiation right through to verified closure

No more uncontrolled changes. No manual sign-off processes. No compliance gaps.

Every change is formally governed, digitally signed, and completely traceable — from first request to final close-out.

Built on 3 Core Pillars

SUBMIT

Raise change requests with detailed descriptions, specific deliverables, and all supporting attachments — capturing everything needed for proper evaluation from the outset.

IMPLEMENT

Route changes through structured pre- and post-approval workflows with digital signatures and full stakeholder alignment — ensuring no change is actioned without proper authorisation.

CLOSE-OUT

Track real-time implementation progress, monitor tasks and due dates, and confirm closure with a complete compliance record that stands up to any audit or regulatory review.

Why Teams Choose ChangeM

ChangeM is purpose-built for project and programme teams where governance, compliance, and accountability are not optional — they are fundamental to project success:

1

Replace informal, email-based change processes with a structured, compliant platform

2

Improve real-time visibility across all active changes, approvals, and outstanding tasks

3

Enhance accountability with formal digital sign-off at every stage of the change lifecycle

4

Customise change workflows to suit your project, industry, or regulatory requirements

5

Support remote and globally distributed teams with secure 24/7 access in the language of their choice

6

Maintain all project changes including attachments for complete knowledge management

About goPLIMS

goPLIMS is an Integrated Project Execution & Management Platform — delivering real-time visibility, workflow governance, and compliance-ready execution across the entire project lifecycle. Purpose-built for pharma and regulated industries, goPLIMS reduces coordination time by up to 50%, helping teams accelerate speed to market.