Life Sciences Software Solutions

Life sciences and pharmaceutical manufacturers operate in the most regulated production environment on earth. Every batch, every step, every signature carries the weight of patient safety — and the cost of a single deviation, contamination event, or data integrity failure can mean a destroyed batch, an FDA 483 observation, a consent decree, or worse. Yet many facilities are still running on paper batch records, manual SOPs, and disconnected systems that make real-time oversight nearly impossible and audits a months-long ordeal. Documentation activities alone consume up to 30% of staff time in pharma manufacturing. With increasing regulatory scrutiny from the FDA and EMA, the shift from schedule-based maintenance to condition-based practices, and growing pressure to accelerate time to market for complex new modalities, the need to digitize and connect operations has never been more urgent. Proficy® Software Commercial Operations from Velotic, deployed and supported by Cybergear, brings together HMI/SCADA, batch execution, MES, and industrial data management into a proven, validated platform purpose-built for regulated environments. With decades of pharmaceutical and life sciences deployment experience, Proficy® gives manufacturers the data integrity, traceability, and operational control they need to protect products, satisfy regulators, and build a foundation for continuous improvement.

• Enforce digital recipes and SOPs at every step of the batch — guiding operators through each task, capturing data automatically, and preventing process excursions before they become deviations.
• Generate complete Electronic Batch Records (EBR) automatically, with data populated directly from the plant SCADA system and operator e-signatures at every review point — reducing paper and accelerating batch review and release.
• Maintain a fully auditable 21 CFR Part 11-compliant data historian — storing time-series process data with tamper-proof records, secure access controls, and rapid retrieval for FDA inspections and deviation investigations.
• Monitor equipment health and production performance continuously, enabling a shift from schedule-based maintenance to condition-based practices that reduce unplanned downtime and contamination risk.
• Connect production, quality, and lab data across systems and sites into a single source of truth — eliminating the data silos that delay batch disposition decisions.
• Scale from a single line to a global multi-site enterprise with centralized templates, standardized workflows, and site-level flexibility.

Life sciences facilities generate enormous volumes of critical process data across HMI/SCADA, batch execution systems, historians, LIMS, and quality management platforms — but too often that data lives in silos that slow batch release, complicate investigations, and create compliance risk when regulators come calling. Proficy Operations Hub consolidates it all into a single, cloud-ready, web-based interface built for regulated environments. Role-based dashboards give operators, engineers, quality reviewers, and plant managers precisely the view they need to do their jobs efficiently — from production floor to batch disposition. Real-time exception monitoring surfaces process deviations, equipment alarms, and quality events the moment they occur, enabling immediate operator response before a deviation escalates into a batch failure or CAPA. And because Proficy Operations Hub integrates with third-party systems as naturally as it does with the native Proficy suite — including LIMS, QMS, ERP, and DCS platforms — it brings together the complete operational picture without replacing the validated systems already in place.