Multi-Stage SOP Approval Workflow Requirement

Business Need

MDM Standard Operating Procedures (SOPs) require a controlled, auditable review and approval process to ensure documents remain accurate, compliant, and approved by the appropriate stakeholders before publication.

The current review process involves an SOP Owner, multiple reviewers, and final approvers. The system must support this workflow while maintaining a complete audit trail of all review activities, approvals, comments, and version history.

Required Workflow

Stage 1: Ownership & Review Notification

Each SOP must have an assigned SOP Owner.

The SOP Owner is accountable for document accuracy and maintenance.

When the document reaches its scheduled review date:

The SOP Owner is automatically notified.

The SOP status changes to Review Due.

The SOP Owner may:

Review the document.

Make required updates.

Submit the document to the reviewer stage.

Stage 2: Reviewer Approval Cycle

The SOP Owner submits the SOP to a designated group of reviewers.

Multiple reviewers must be supported.

Each reviewer receives a notification requesting review.

Each reviewer must have the ability to:

Approve the document.

Reject the document.

Leave comments or recommended updates.

Record the date and time of their decision.

If any reviewer requests changes:

The SOP is returned to the SOP Owner.

Reviewer comments are retained and visible.

The SOP Owner makes updates and resubmits.

Stage 3: Reviewer Completion Gate

The SOP cannot advance until all required reviewers have approved.

The system must display:

Pending reviewers

Approved reviewers

Rejected reviewers

Reviewer comments

Once all required reviewers approve:

The document automatically advances to the next stage.

Stage 4: Final Approval / Ready to Publish

After reviewer approval:

The SOP moves to Final Approval or Ready to Publish status.

Final approvers receive notification.

Final approvers can:

Approve for publication

Reject and send back for revision

Provide comments

Upon approval:

The document status changes to Published.

The publication date is recorded.

Audit Trail Requirements

The system must maintain a complete audit record for each SOP version.

For every review cycle, the following should be stored:

SOP Version Number

SOP Owner

Reviewer names

Approver names

Approval dates

Rejection dates

Reviewer comments

Approver comments

Status history

Review completion date

Publication date

Version History Requirements:

| Field | Requirement |

| ----------------- | ------------------------------- |

| Version Number | Stored for every revision |

| Modified By | Name of user making the change |

| Modification Date | Date/time stamp |

| Review Actions | Approvals, rejections, comments |

| Approval Records | Permanent record of approvals |

| Reviewer Comments | Retained with version |

| Published Version | Identifiable and reportable |

The system should provide visibility into:

SOPs due for review

Overdue SOP reviews

SOPs awaiting reviewer approval

SOPs awaiting final approval

Published SOPs

Approval history by SOP

Reviewer participation history

Audit-ready approval records

Success Criteria

An SOP review cycle is considered complete only when:

The SOP Owner reviews and updates the document.

All assigned reviewers approve the document.

Final approver(s) approve the document.

All approvals, comments, and dates are permanently stored in version history.

The SOP is published with a complete audit trail available for governance, compliance, and audit purposes.

Key Requirement: The approval workflow must support sequential stages (Owner → Multiple Reviewers → Final Approver → Publish) and provide a permanent, auditable record of every approval, rejection, comment, and version change.

This language usually resonates well with software developers because it clearly defines the workflow states, business rules, gate conditions, notifications, and audit requirements without prescribing how they must technically build it.