Pharmaceutical

Ensure right-first-time weighing and eliminate formulation deviations with precision controls tied to approved MMRs. V5 verifies material ID via barcode scanning, enforces real-time weight tolerances with integrated scales, and restricts unauthorized substitutions or overages. Every gram is tracked, timestamped, and signed electronically — supporting Part 11 validation and clean batch history.

Transform manual production into a controlled, repeatable digital workflow. V5 enforces execution steps defined in the BPR/MMR, restricts operator actions, and records each step with full audit trails. Blend control, mixing, heating, and transfer steps are time- and user-validated — reducing risk of deviations and expediting QA release.

Build quality into the process, not just at the end. V5 prompts and enforces IPCs (in-process checks) such as pH, viscosity, weight verification, and temperature recording at the exact stage required. Failed checks can halt production automatically or trigger CAPA, ensuring compliance with 21 CFR Part 210/211 and minimizing rework.

No more binders. V5 generates real-time eBRs by collecting data directly from equipment (scales, printers, scanners), user inputs, and system controls. Each action is timestamped, digitally signed, and linked to the user ID — ensuring complete, tamper-proof records for QA review, audit readiness, and faster batch release.

Enforce full serialization down to the unit level. V5 integrates with printers and vision systems to apply and verify GS1 or custom serialized barcodes. Automatic line clearance verification, label reconciliation, and aggregation ensure compliance with DSCSA, EU FMD, and TGA requirements — all captured in the batch record.

V5 is engineered to support FDA, EU Annex 11, and WHO GMP frameworks. From controlled user access and system validations to electronic signatures and audit trails, compliance is not an afterthought — it’s built into every workflow. Simplify validation with change control, document versioning, and CFR Part 11 readiness out of the box.

Immediately capture process, equipment, or material deviations in real-time — at the point of failure. V5 enables operators and QA to log non-conformances with full traceability to batch, lot, equipment, and personnel. Built-in root cause prompts and severity classification accelerate triage and ensure each NCR is tracked through resolution.

Turn quality issues into process improvements. V5’s CAPA engine links seamlessly with NCRs, deviations, audits, and customer complaints. Investigations, effectiveness checks, and approvals are enforced with electronic signatures and full audit trails. CAPA aging reports and KPI dashboards help ensure nothing slips through the cracks.

Prepare, execute, and follow up on internal or regulatory audits directly within V5. Schedule recurring GMP audits, assign findings to responsible owners, and track corrective actions through to closure. With real-time audit history and linked evidence, your QA team is always inspection-ready — whether it’s the FDA, EMA, or MHRA knocking.

V5 includes a built-in lightweight LIMS module for manufacturers who need lab result tracking without the overhead of a separate system. It allows recording of test results, auto-hold/release of lots based on pass/fail thresholds, and links directly to the batch record. For operations already using external LIMS platforms, V5 supports bi-directional integration to pull results, automate holds, and trigger batch release actions — ensuring QC and production operate as one seamless unit. Whether you’re running internal testing or connecting to validated third-party systems, V5 bridges the gap between quality and execution.

Ensure no batch is touched by unqualified personnel. V5 tracks training records, SOP sign-offs, and certifications — enforcing training dependencies before task execution. When procedures change, affected team members are automatically flagged for retraining. 21 CFR Part 211.25 compliance, baked in.A

Maintain complete control over SOPs, work instructions, specifications, and quality manuals. V5 enforces version control, change history, review cycles, and multi-level approvals with electronic signatures. Only the latest, approved version is visible on the shop floor — with full traceability of who viewed and signed what, when.

Track planned and unplanned deviations from GMP procedures, formulas, or specifications. V5 enforces escalation protocols based on deviation type, links investigations and CAPAs, and ensures impact assessments are performed. Every deviation is documented, classified, and closed with accountability.

Track calibration, maintenance, and qualification status of every GMP-critical asset. Whether it’s a scale, mixer, or filling line, V5 ensures equipment is in-spec and ready for use. Alerts, usage logs, and preventive maintenance schedules help you stay ahead of downtime and audit findings.

Map approval chains to your exact quality system. Whether it’s a 1-step sign-off or multi-department review, V5 lets you configure electronic workflows with role-based access and timestamped signatures. Use it for CAPAs, deviations, SOP changes, batch dispositions — anything that requires formal approval.

Support compliance with DEA, EU, and global controlled substance regulations. V5 enforces dual sign-off for high-risk operations, logs every movement and quantity change, and ensures accurate reconciliation of Schedule I–V substances. Real-time reports and alerts help prevent diversion and ensure inspection-readiness.

Accelerate inbound logistics while maintaining compliance. V5 scans and validates every incoming item against POs and COAs, then directs material to the correct storage zone based on material type, temperature, and quarantine status. First-expiry-first-out (FEFO) logic and configurable putaway rules ensure precise inventory rotation from day one.

Reduce mispicks and streamline production staging with guided workflows. V5 enforces barcode scanning for every pick, validates against batch/lot requirements, and generates precise pick lists tied to work orders or MMRs. For dispensing, the system ensures exact weights and materials are staged at the correct time and location, minimizing downtime and scrap.

Get the right product to the right customer every time. V5 validates each outbound shipment against customer specs, sales orders, and packaging rules — including serialization and labeling if required. Pack verification, weight checks, and digital sign-offs reduce fulfillment errors and boost customer confidence.

Know what’s on hand, where it is, and what it’s doing — in real time. V5 provides dynamic inventory dashboards with filters by lot, expiry, quarantine, location, and status. Search by material, SKU, or barcode to get instant answers — whether for internal transfers, cycle counts, or FDA inspections.

Maintain DEA, TGA, or EU FMD compliance with built-in handling restrictions for Schedule I–V materials. V5 tracks chain of custody, enforces dual sign-off, and restricts access by role and zone. Every movement is logged with timestamp and user ID — supporting inventory reconciliation and diversion prevention with zero gaps.

Tie warehouse operations directly into your quality system. V5 flags holds, expired lots, or failed COAs automatically and prevents release or use until resolved. Integration with NCRs and CAPAs ensures all GMP-impacting inventory actions are recorded and addressed in a compliant manner.

Track every drum, bottle, or bag from receipt to release — across production, staging, and distribution. V5 enables full forward and backward traceability within seconds, with links to vendor COAs, internal test results, and batch history. Supports 21 CFR Part 11, 211, and EU Annex 11 requirements.

Never miss a shelf-life deadline. V5 calculates expiration automatically based on receipt or manufacture date and enforces FEFO/LEFO rules during picking. Alerts highlight items nearing expiry, and expired material is automatically quarantined to prevent unintended use or shipment.

Map your physical warehouse structure into logical locations — aisles, bins, zones — with control over temperature, security, and access. Whether you’re operating cleanrooms, cold storage, or DEA vaults, V5 adapts to your footprint and ensures location-specific rules are enforced.

Generate audit-ready reports on inventory movements, adjustments, expirations, and chain-of-custody with a single click. V5 supports electronic logs, export to Excel/PDF, and configurable reporting schedules. Be ready for FDA 483s, DEA audits, or internal reviews without scrambling.