V5 Checklist Automation – Enforced Compliance for Regulated Manufacturing

Checklist Automation in V5 Enterprise gives regulated manufacturers a digital, enforced, and traceable way to confirm critical quality steps—on time, on record, and without room for human error. Whether confirming sanitation, allergen control, or line clearance, V5 ensures every checklist step is executed, verified, and escalated if necessary.

Unlike static forms or editable PDFs, V5 checklists are embedded directly into batch workflows, linked to specific jobs, timed schedules, or locations. This ensures compliance with your SOPs—whether they’re driven by FDA, ISO 9001, GFSI, or internal standards—and gives you complete confidence in production floor activity.

“We went from ‘we think it was done’ to ‘we know it was done.’ V5 forces every operator to do it, document it, and escalate it if needed.”
— QA Manager, Contract Manufacturer

Checklists That Are Always On-Time and On-Target

V5 checklists are triggered dynamically based on the manufacturing environment. They can be tied to:

• Production batches – e.g., pre-mix or pre-fill checks
• Job steps – e.g., line clearance or allergen swabbing
• Locations – room, line, or equipment-specific enforcement
• Scheduled intervals – hourly, shift-based, or daily routines

Operators are forced to complete assigned checklists before continuing the workflow. Missed checks, skipped fields, or failed validations automatically trigger alerts, ensuring proactive correction rather than post-batch investigation.

Deviation Detection, NCR Escalation & CAPA Integration

If a checklist item fails or isn’t completed as required, V5 logs the event as a deviation. These deviations can automatically be elevated to a Non-Conformance Report (NCR) and escalated through a defined hierarchy with timed service-level triggers. If unresolved within the expected timeframe, the issue continues to escalate—until action is taken or a CAPA is formally initiated.

• Failed checklist steps trigger automatic deviations
• Deviations escalate as NCRs through a customer-defined hierarchy
• Timers ensure response within SLA thresholds
• CAPAs can be generated with root cause and corrective action traceability
• All actions are logged in a full audit trail with time and user stamps

This level of control ensures that nothing falls through the cracks. Each quality issue is visible, measurable, and accountable—whether resolved on the floor or escalated to corporate QA.

Review & Approval with the 4-Eyes Principle

To ensure high-integrity compliance, V5 includes an optional review-and-approval process that enforces the 4-eyes principle. This means that no critical checklist—especially those tied to batch release, sanitation verification, or deviation closure—can be completed without a second user independently reviewing and signing off on the data.

• Dual sign-off enforcement for high-risk checkpoints
• Reviewers must be different from original operator
• Electronic signatures meet 21 CFR Part 11 and Annex 11 requirements
• Full traceability of who signed, when, and why
• Helps meet GMP, GAMP 5, and ISO 13485 expectations

“We now have proof that every check was done—and that someone else validated it. That’s how you build real trust in a regulated plant.”
— VP of Compliance, Food & Beverage Manufacturer

Enterprise-Level Enforcement, Exclusive to V5

Checklist Automation is only available in the Enterprise Tier of V5. It’s built for manufacturers who require full enforcement of quality steps, reliable deviation escalation, and audit-ready records—without relying on memory, paper, or third-party forms.

• Enforced checklist workflows at the line level
• Escalation rules built into every deviation path
• Integrated with batch records, SPC, and QA dashboards
• Supports multi-site configuration and site-specific SOPs
• Fully digital, paperless enforcement for regulated industries

Whether you’re producing pharmaceuticals, cosmetics, dietary supplements, foods, or chemicals, V5 ensures checklist completion isn’t optional—it’s enforced, traceable, and integrated into your compliance infrastructure.

Discover how Checklist Automation in V5 Enterprise helps you enforce the processes you’ve defined—and gives regulators, auditors, and leadership complete confidence in your production controls.