Intelligent Change Control Workflow Design in Vault Quality - Moving Beyond Basic Automation

Change control is a foundational process in Vault Quality that ensures modifications -whether to documents, procedures, systems, or products - are introduced in a controlled, auditable, and risk-appropriate way. Its purpose is simple but critical:

To maintain confidence and traceability whenever a change has the potential to affect quality, compliance, or operations.

Vault Quality implements change control as a connected system of objects and behavior, where lifecycles, workflows, entry actions, and relationships work together to reflect real quality practice - not just a sequence of approvals.

At a high level, change control addresses four core questions:

1. Why is the change needed?

2. What will it impact?

3. Who must evaluate and approve it?

4. How do we know it was successful?

A strong change control process helps:

• maintain regulatory compliance

• align quality and business priorities

• reduce cycle times and manual coordination

• embed decision logic, not just automation

Vault Quality’s design helps teams convert these questions into controlled behavior inside the platform.

Change Control Process

Create Change Control

The process begins when a quality professional creates a Change Control record in Vault Quality - the primary governing object for the change.

This record captures:

• Business Justification

• Impact and Risk Indicators

• Ownership and Responsibilities

• Change classification

Risk & Impact Assessment

After the Change Control exists, the planning stage focuses on assessing:

• Risk and Impact

• Affected products, organizations, or processes

• Affected documentation and systems

These assessments feed Vault’s configuration logic (entry actions and workflows). If risk and impact remain disconnected from behavior, the system only records data rather than uses it for decisions.

Entry Action Triggers workflows

Change workflows in Vault Quality are triggered by entry actions on lifecycle state transitions. Entry actions are configured to start the correct workflow based on risk, type, and impact. It also ensures auditability and evidence capture

This allows Vault to respond differently to, for example:

• low-risk document updates

• system configuration changes

• cross-functional regulatory impacts

The result: adaptive automation instead of fixed linear sequences.

Approvals - Purposeful, Not Exhaustive

Approval workflows in Vault are not meant to collect signatures. They are meant to enable decisions at the right time and by the right people.

Conditional logic ensures that:

• reviewers relevant to the specific impact are included

• unnecessary steps are avoided

• loops and bottlenecks are minimized

This keeps the process aligned with real quality decision paths, rather than arbitrary routing.

Document Change Control

A core part of many changes involves documentation - and Vault Quality has explicit support for this through Document Change Control (DCC).

• Single-Document Change Control : A Document Change Control record is linked to the document to manage its draft, approval, release, or obsolescence. This ensures the document itself transitions through appropriate states as part of the change.

• Multi-Document Change Control : When multiple documents are impacted, The DCC record orchestrates changes across all of them. This keeps document state aligned with the overall change without additional manual coordination.

Document Change Requests - A Parallel Intake Mechanism

In many environments, users first identify a need to revise a document and log a Document Change Request (DCR).

DCRs:

• capture grassroots requests for document changes

• can be linked to a DCC when a broader change plan is formalized

• automatically close when the document reaches an approved or obsolete state

Change Actions - Execution Outside Documentation

Not all change work is about documents. For activities such as:

• system configuration updates

• process rollouts

• equipment changes

Vault uses Change Actions - records linked to the main Change Control that track execution work and responsibilities.

Each Change Action:

• has designated owners and approvers

• tracks implementation tasks

• ensures visibility into execution progress

This avoids mixing execution details into approval workflows and improves accountability.

Verifying Outcomes - Effectiveness Checks

Approval and implementation are not the end. Vault Quality supports Effectiveness Checks that confirm whether the desired outcome of the change was achieved - closing the loop between intention and result.

Effectiveness Checks:

• are linked to the Change Control

• are often required before closure

• provide measurable validation of results

Closure - Controlled and Evidence Driven

Before a Change Control can be closed, Vault ensures:

• required approvals are complete

• all Document Change Controls are finalized

• all Change Actions are complete

• Effectiveness Checks (if configured) are completed

This prevents premature closure and ensures a complete quality narrative.

Closing Perspective

Vault Quality’s change control model is more than automation. It is a connected system that reflects real quality practice:

• Decisions based on risk and impact

• Documents managed in context

• Execution traceable and accountable

• Outcomes verified and recorded

This approach minimizes manual coordination, reduces cycle times, and enhances quality confidence across the organization, all within a structured, auditable framework that regulators respect.