Pharmaceutical manufacturers running Opcenter Execution generate rich production data but lack real-time visibility to act on it. OYTEC solves this by deploying Opcenter Intelligence with GxP-validated dashboards for OEE, batch analytics, Golden Batch and CPV; enabling operations and quality teams to reduce batch deviations, cut unplanned downtime and accelerate QA release, without adding compliance risk.
Connect to MES, ERP, LIMS and IoT sources natively. All manufacturing data is normalized into a single analytical model based on ISA-95, giving operations, quality and management teams a single source of truth for production metrics.
Access pre-built dashboard templates for OEE, batch summary, yield and downtime. OYTEC configures these to your plant specificities and pre-validates them for electronic records compliance, eliminating custom validation efforts.
Compare every new batch against your validated reference to detect process drift early. This built-in statistical capability directly supports Continued Process Verification (CPV) programs required by ICH Q10 and FDA guidelines.
Extract compliance data directly from production records to generate Product Quality Reviews (PQR) and CPV reports. OYTEC adapts the reporting structures to align perfectly with EMA GMP Chapter 1 and FDA 21 CFR Part 211 requirements.
Monitor machine, line and plant performance across multiple global sites from a single cloud instance. Near real-time data normalization allows for accurate cross-plant comparisons without the need for manual Excel consolidation.