From Lab Results to Release: Closing the Gap
The native LIMS in V5 brings lab testing, quality checks, and production execution into a single, automated workflow. It’s built directly into the V5 platform—no third-party tools required. By embedding laboratory workflows within your MES and QMS environment, V5 ensures that no batch is released without verified, timestamped, and compliant test results.
Designed for regulated industries—from pharma to food to cosmetics—V5 automates lab data capture, batch holds, and releases. Because this LIMS is native to V5, there’s no delay, sync issues, or external dependencies—just faster decisions, fewer errors, and audit-ready traceability. Additionally, for companies already operating a third-party LIMS, V5 can integrate external lab data into the master manufacturing record—ensuring seamless traceability and control without duplicate data entry.
“We no longer wait on QA. Test results trigger the release automatically, and we trust every data point.”
— Director of Operations, Nutraceutical Manufacturer
Lab Results Trigger Real-Time Action
Too often, production is delayed or compromised due to missing or late lab results. V5 eliminates this lag by integrating test data directly into batch workflows. Every result is validated, and actions are triggered in real time. Results aren’t just attached—they’re enforced.
- Automated batch hold/release based on lab data
- Direct linkage of test results to specific batches and lots
- Threshold-based alerts and deviation capture
- Electronic signatures on test approval
- Instant QA visibility into in-progress and completed tests
Built-In LIMS or Third-Party Integration
V5 includes a lightweight, configurable LIMS module for managing test plans, sampling schedules, and data capture. QA teams can define test criteria, set up automatic triggers, and maintain method compliance with full traceability. Where external LIMS systems already exist, V5 supports bidirectional communication and secure data exchange to bring lab outputs into MES-level decision logic.
- Create and manage test methods in V5
- Assign tests by batch, lot, or product line
- Capture results with pass/fail validation and audit trace
- Connect to external LIMS via API, XML, or flat file
- Trigger downstream MES and QMS events from test outcomes
Compliance Without the Waiting Game
V5 enforces regulatory compliance without slowing production. Every test record is traceable, signed, and time-stamped in line with your industry’s most stringent requirements. No paper. No guesswork. Just digital enforcement with a full audit trail.
- 21 CFR Part 11 compliant electronic records and signatures
- Automatic deviation alerts and escalation routing
- CAPA linkage to failed tests and root cause analysis
- Regulatory traceability across QA, Production, and Lab functions
- Supports ISO 13485, EU Annex 11, GAMP 5, and more
“When the lab passes a batch, production sees it instantly. We trust the data and the process, which means fewer meetings and zero delays.”
— QA Manager, Cosmetic Manufacturing Facility
Trusted Across Regulated Manufacturing
Whether you manufacture pharmaceuticals, dietary supplements, medical devices, food, or personal care products, your testing program is the gatekeeper for quality. V5 ensures this gate is automated, documented, and protected from human error.
- Ensures release decisions are data-driven, not manual
- Synchronizes lab QA with shop floor execution
- Reduces rework and scrap from missed specs
- Digitally connects SOPs, test plans, and release workflows
- Eliminates bottlenecks in lab-to-lot clearance
Test results can be used to automatically generate Certificates of Analysis (COAs), providing instant proof of compliance and product quality. Sample data can also be retained for Statistical Process Control (SPC) analysis or displayed in real time on large KPI monitors—ensuring lab performance metrics are visible and actionable on the shop floor.
