Standard Operating Procedures (SOPs)

ProBeya's SOP module implements the controlled document lifecycle that pharma and manufacturing regulators require. SOPs flow through a formal workflow -- draft, review, approved, effective, superseded, retired -- with full revision history and audit trail at every transition.

SOPs are regulatory requirements under 21 CFR Part 211 (US), EU GMP Annex 15, and ICH Q10. This module ensures your procedures are written, reviewed, approved, and maintained in a way that satisfies GxP inspectors while remaining practical for day-to-day operations.

Overview

Managing SOPs in spreadsheets or shared drives creates compliance risk: documents get edited without approval, versions proliferate without control, and there is no audit trail of who approved what and when. Regulators expect controlled documents with formal lifecycle management.

ProBeya solves this with a purpose-built SOP system that enforces the pharma-standard document lifecycle:

• Only draft SOPs can be edited
• Review requires explicit submission from the author
• Approval records who approved, when, and the effective date
• Rejection returns the SOP to draft with a mandatory reason
• New versions create a complete clone of the previous version, marking the original as superseded
• Every lifecycle transition is recorded in an append-only revision history

Getting Started

1. Navigate to a workspace and select Lean > SOPs from the sidebar.
2. Click New SOP and provide a title, SOP number, owner, purpose, and scope.
3. Add steps to the SOP, defining the procedure in execution sequence.
4. Mark any steps that are quality-critical (GxP flag) or have safety warnings.
5. When the SOP is ready, click Submit for Review to move it into the review workflow.
6. The designated reviewer can then Approve (setting an effective date) or Reject (returning to draft with a reason).

Key Concepts

Term	Definition
SOP Number	A unique document identifier following organizational numbering conventions (e.g., SOP-QA-042).
Version	Integer version number, starting at 1. Incremented each time a new version is created from an approved/effective SOP.
Status	The document lifecycle state: draft, review, approved, effective, superseded, or retired.
Quality-Critical Step	A step flagged as GxP-critical, requiring extra attention during execution and training.
Safety Warning	A caution or danger note attached to a step to protect operator safety.
Revision History	An append-only JSONB log recording every lifecycle transition with timestamp, author, and description.
Superseded	A previous version of the SOP that has been replaced by a newer version. Retained for audit trail purposes.

How It Works

Document Lifecycle

  draft ──► review ──► approved ──► effective ──► superseded
    ▲          │                                       │
    └──────────┘ (reject)                              │
                                                  retired

Transition	Trigger	Side Effects
draft → review	Author submits for review	Revision history entry logged
review → approved	Reviewer approves	Approver and effective date recorded
review → draft	Reviewer rejects	Mandatory rejection reason logged in revision history
approved → effective	Automatic or manual	SOP becomes the operative document
effective → superseded	New version created	Current version marked superseded, new draft version created
any → retired	Manual retirement	Document removed from active use

Step Management

Each SOP contains an ordered list of steps, each with:

• Step Number -- The sequential identifier (e.g., "3.1", "3.2")
• Instruction -- The detailed procedure text
• Responsible -- Who performs this step (role or person)
• Safety Warning -- Optional caution/danger text displayed prominently
• Quality Critical -- Boolean GxP flag indicating the step requires heightened compliance attention
• Expected Duration -- How long the step typically takes
• Attachments -- Array of file references (images, forms, checklists)
• Sort Order -- Controls the step display sequence

Steps can only be added, edited, removed, or reordered when the parent SOP is in draft status. This prevents unauthorized modifications to approved or effective documents.

Version Control

When a new version is needed (e.g., after a process change), the createNewVersion procedure:

1. Validates the current SOP is in approved or effective status
2. Marks the current version as superseded
3. Creates a new SOP record with version + 1 in draft status
4. Clones all steps from the current version to the new version
5. Records the change description in the revision history

The result is a complete version chain: SOP-QA-042 v1 (superseded) → SOP-QA-042 v2 (draft). The author can then modify the draft and submit it through the review/approval cycle.

Edit Restrictions

ProBeya enforces strict edit restrictions aligned with pharma document control:

• Draft SOPs -- Freely editable. Steps can be added, modified, reordered, or removed.
• Review SOPs -- Cannot be edited. Must be approved or rejected.
• Approved/Effective SOPs -- Cannot be edited. Must create a new version to make changes.
• Only draft SOPs can be deleted -- Active documents are never deleted; they are retired instead to maintain the audit trail.

PDF Export (Planned)

A placeholder generatePdf procedure exists for future PDF export capability. This will generate a printable version of the SOP suitable for shop-floor distribution and GxP documentation binders.

Configuration

Setting	Description
SOP Number	Unique identifier following your organization's document numbering scheme.
Department	Optional department assignment for filtering and accountability.
Category	Optional classification (e.g., "Manufacturing," "QA," "Packaging").
References	Array of related document numbers or external references.
Effective Date	Set during approval to define when the SOP takes effect.
Review Date	Scheduled date for periodic review (regulatory requirement).

SOPs can be filtered by status, department, and category in the list view. The list is sorted by SOP number then version descending, showing the latest version of each document first.

Permissions

Role	Capabilities
Workspace Member	View SOPs and their steps
SOP Author	Create SOPs, edit draft SOPs, add/remove steps, submit for review
SOP Reviewer	Approve or reject SOPs in review status
Workspace Admin	All capabilities including delete (draft only) and version creation
Organization Admin	Full access across all workspaces

The approval workflow enforces separation of duties: the reviewer should not be the same person who authored the SOP (organizational policy, not system-enforced).

Tips & Best Practices

Use quality-critical flags consistently

Flag every step that directly impacts product quality or patient safety as quality-critical. This makes it easy to identify which steps require enhanced training, monitoring, and deviation investigation.

Plan periodic reviews

Set the review date when approving an SOP. Pharma regulations typically require SOP review every 1-2 years. ProBeya stores the review date to support this compliance requirement.

Keep revision history meaningful

When submitting for review or creating a new version, always provide a clear description of what changed and why. Generic comments like "updated" provide no audit trail value.

Never delete approved SOPs

Even if an SOP is no longer needed, retire it instead of deleting. The system enforces this for non-draft SOPs, but the principle should guide your document management policy.

Troubleshooting

Issue	Resolution
Cannot edit SOP	Only draft SOPs can be edited. If the SOP is in review, approved, or effective status, create a new version to make changes.
Cannot delete SOP	Only draft SOPs can be deleted. Effective or approved SOPs must be retired to maintain the audit trail.
Steps not saving	Verify the parent SOP is in draft status. Steps cannot be modified on non-draft SOPs.
Cannot create new version	Only approved or effective SOPs can be versioned. Draft SOPs should be edited directly.
Approval rejected but no reason shown	The system requires a mandatory rejection reason. Check the revision history for the rejection entry.

Related Features

• SIPOC Diagrams -- Define process boundaries before writing the detailed SOP for each process.
• FMEA Analysis -- FMEA identifies which process steps need the most rigorous controls; reflect these in SOP quality-critical flags.
• Voice of Customer -- CTQ specifications from VOC studies define the acceptance criteria that SOPs must deliver.
• Approval Workflows -- For additional approval complexity, combine SOP review with the multi-step approval workflow engine.
• Audit Management -- Audits can verify that operators follow SOPs correctly and flag deviations.