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Change Control

Module

Overview

Unifize’s Change Control module ensures every change is intentional, traceable, and compliant. It connects impact analysis, approvals, and task execution—so you can manage revisions across documents and processes without losing control.

Key Features and Benefits

Each feature in Change Control helps standardize change execution while maintaining full traceability across impacted records.

Feature
Benefit

Centralized change request creation and tracking

Change Control is supported by core processes that track each request, its execution tasks, and related responsibilities.

Process
What it does

Ensures all changes are reviewed, documented, and approved

Role-based implementation task assignment

Aligns accountability by department and function

Impact analysis linking to documents and training

Surfaces downstream effects early in the change process

Lifecycle-controlled closure

Enforces structured progress and timely completion

Traceability to training and document versions

Proves changes were communicated and adopted

Escalation logic for overdue changes

Enables proactive intervention to avoid compliance gaps

Document Change Control

Captures scope, rationale, impacted documents, and approval cycle

Implementation Task

Breaks down execution into discrete, assignable actions per change

Included Processes

Document Management

Module

Overview

Unifize’s Document Management module brings order and compliance to your controlled documents. From drafting to approval to retrieval, every SOP, policy, or record is traceable, versioned, and audit-ready—without spreadsheets or email threads.

Key Features and Benefits

Each feature in Document Management is designed to enforce control, maintain compliance, and simplify collaboration across departments.

Feature
Benefit

Centralized repository for controlled documents

Unifize Document Management is powered by core processes that manage the lifecycle, context, and classification of controlled documents.

Process
What it does

Ensures all critical content is accessible, current, and version-controlled

Periodic and ad hoc review scheduling

Keeps SOPs, policies, and other controlled documents aligned with regulatory requirements

Lifecycle-controlled permissions

Locks down editing rights and visibility based on status

Live audit trail on every document

Proves ownership, changes, and approvals in one click

Document classification and template references

Standardizes documentation and drives automation logic

Linked training triggers from document updates

Automatically notifies relevant users to retrain on revisions

Document

Stores metadata and files; manages versioning and lifecycle

Document Review

Tracks periodic and event-driven review cycles

Type of Document

Included Processes

Maintains classification references for filtering and training logic

Template

Houses approved templates to drive document standardization

Document Management System (DMS)

Product

Overview

Unifize DMS ensures everyone is always working with the most current, approved version of every critical document—without spreadsheets, email chains, or file confusion. It keeps teams aligned and compliant by tightly connecting document control, change implementation, and training within one traceable platform.

Key Features and Benefits

Each feature in Unifize DMS is designed to drive a measurable outcome. This table maps core capabilities directly to the operational and compliance benefits they deliver, so you know exactly what you’re getting and why it matters.

Feature
Benefit

Unifize DMS is built around three tightly integrated modules. Each one tackles a distinct part of the compliance cycle—documents, changes, and training—while working together to deliver complete traceability and control.

Unifize uses a tiered licensing model to match user capabilities with their responsibilities. From full administrative control to view-only access, each license type ensures users have the necessary capabilities without compromising control or compliance.

Enforces 21 CFR Part 11-compliant eSignatures

Ensures regulatory compliance for all approvals

Auto-triggers training on document release or revision

Keeps teams trained on the latest SOPs, policies, and other controlled documents automatically

Lifecycle-controlled access and editability

Prevents unauthorized edits and controls visibility

Complete audit trail on every record

Reduces audit prep time and proves accountability instantly

Linked record traceability across documents, changes, and training

Enables end-to-end visibility and impact analysis

Integrates with existing systems of record, like SharePoint

Enhances existing repositories by adding compliance, traceability, and workflows

Full

Grants the ability to create, edit, approve, and configure processes and records

Limited

Allows task execution and participation in assigned records and reviews without final approval rights

Free

Read-only or checklist-contributor access for training, audits, and external collaborators

Included Modules

Licenses and Entitlements

Author, approve, and version critical documents

Initiate and execute controlled changes with task accountability

Assign, track, and verify training on SOPs, policies, and other controlled documents

Document Management
Change Control
Training Management

Training Management

Module

Overview

Unifize’s Training Management module ensures that employees are always trained to the latest version—automatically. It links training assignments to document lifecycles, ensuring that nothing falls through the cracks when an SOP changes.

Key Features and Benefits

Each feature in Training Management ensures continuous compliance, faster rollouts, and complete traceability.

Feature
Benefit

Auto-assignment of training upon document release or revision

Training Management operates through modular processes that define, assign, and verify role-based training.

Process
What it does

Ensures employees are always trained to current procedures

Role and department-based training groups

Streamlines large-scale assignments by team, site, or function

Embedded quizzes and version-linked tracking

Validates comprehension and ensures alignment to document versions

Real-time training status by user or group

Enables managers to monitor and intervene before gaps emerge

Timestamped records for audit and compliance

Proves who was trained, on what, and when

Revision-triggered re-training logic

Eliminates manual follow-ups when SOPs are updated

Training Module

Houses course content, document links, and quiz requirements

Training Record

Tracks assignment, completion, and acknowledgment by the user

Training Group

Included Processes

Defines cohorts based on role, department, or site

Quiz Question

Stores individual assessment items for training modules

Quiz Question Template

Reusable structure for building new quizzes

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