SERVICES & COMPLIANCE
Comprehensive digital services, preventive maintenance, validation engineering, and complete compliance documentation — everything you need to keep your line running and your auditors satisfied.
DIGITAL SERVICES
Real-time KPI monitoring, predictive maintenance alerts, batch record auto-generation, and full 21 CFR Part 11 compliant audit trail — accessible from any browser, anywhere in the world.
ENGINEERING INSIGHT
Click any component to explore the engineering behind our compliance-by-design philosophy.
Use the legend below or click directly on the 3D machine to explore each system.
REMOTE SERVICE
When an issue occurs, our engineers can remotely diagnose and resolve over 80% of issues without a site visit. For complex cases, we connect via AR headset and guide your team step by step through any repair or adjustment.
"Remote diagnostics resolve the majority of issues within hours — not days. Your batch schedule stays on track."
— Head of Global Service Division, VecoplanLIFECYCLE SERVICES
From installation qualification through end-of-life upgrade — structured service programs designed around GMP-compliant uptime.
STANDARD
Annual preventive maintenance visit, emergency hotline access, and spare parts priority ordering.
RECOMMENDED
Quarterly maintenance, Smart Connect monitoring, predictive alerts, and same-day emergency response.
ENTERPRISE
Dedicated service engineer, monthly visits, on-site spare parts store, and complete validation maintenance.
Our structured installation and validation process ensures first-pass audit success.
Full FAT at our facility. Machine runs your actual product profile. Documentation issued and signed before shipment.
IQ protocol executed by our validation engineers on-site. All drawings, calibration records, and material certs included.
OQ testing across full operating range. Alarm testing, interlocks, HMI verification, and SCADA integration confirmed.
PQ with actual product, three consecutive runs. Fill accuracy, rejection rate, CIP cycle, and batch record verification.
VALIDATION SUPPORT
Complete documentation packages, pre-written validation protocols, and on-site validation engineers — all designed to pass FDA and EMA audits without observation, on your first inspection.
REGULATORY COMPLIANCE
Compliance is not a checklist. It is a core engineering discipline built into every component, software module, and documentation package we deliver.
Current Good Manufacturing Practice for Finished Pharmaceuticals. All documentation in FDA-ready format.
Issuing: U.S. FDA · Scope: USA + export to FDA-regulated markets ↓ Download Certificate PDFSterile Medicinal Products — 2022 revision. Full aseptic process, contamination control strategy, and barrier technology compliance.
Issuing: EMA · Scope: EU + EEA + UK MHRA ↓ Download Certificate PDFMedical Devices Quality Management System — demonstrates sustained capability for compliant device manufacturing.
Issuing: ISO/TÜV Rheinland · Scope: Medical device OEMs ↓ Download Certificate PDFQuality Management System — full operations from design through delivery. Annually audited by independent certification body.
Issuing: ISO · Scope: Complete company operations ↓ Download Certificate PDFEU Machinery Directive 2006/42/EC. All machines shipped with full Declaration of Conformity and technical file.
Issuing: Notified Body · Scope: EU Machinery Directive ↓ Download Certificate PDFElectronic Records & Signatures — complete audit trail, e-signature, batch record, SCADA integration standard on all HMI systems.
Issuing: FDA · Scope: All digital/HMI/software systems ↓ Download Certificate PDFTRAINING
Structured training programs for your operators, engineers, and QA team — from basic machine operation to advanced validation and compliance.
OPERATOR
Full machine operation, routine maintenance procedures, GMP record-keeping, alarm response protocols, and CIP/SIP cycle management.
Duration: 3 days · On-site or at Vecoplan facility
ENGINEER
Advanced troubleshooting, preventive maintenance, mechanical and electrical systems, spare parts management, and calibration procedures.
Duration: 5 days · At Vecoplan facility
QA / REGULATORY
IQ/OQ/PQ execution, change control, deviation management, audit trail review, 21 CFR Part 11 compliance, and audit preparation.
Duration: 2 days · Remote or on-site