Production Intelligence for Opcenter Execution Pharma

Production Intelligence for Opcenter Execution Pharma is powered by OYTEC

U OITEC-u stavljamo iskustvo i znanje o našem ljudskom kapitalu u službu za korisnike, nudeći najbolje rešenje za njihove potrebe u skladu sa poslovnim ciljevima: Želja da uspostavimo bliski i trajni partnerski odnos sa našim kupcima zasnovan na međusobnom poverenju, zajedničkom radu i izvrsnosti usluga. Uzimajući u obzir ljudski kapital kao diferencijalni element. Sistemi će biti dizajnirani i razvijeni kako bi pomogli ljudima i podstakli njihovu kreativnost. Nudimo rešenja na premisi specijalizacije kao osnova našeg iskustva i znanja. Uglavnom u okruženjima usklađenosti sa GMP i FDA.

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Why Real-time production intelligence for pharma?

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.

Benefits

Connect your existing MES data to live dashboards without custom development.
Out-of-the-box connectors for Opcenter Execution Pharma deliver OEE, yield and downtime visibility from day one, accelerating your time-to-value.
Bridge the gap between production and quality control.
By connecting Opcenter Execution Pharma with your existing LIMS, this solution provides a unified view of batch execution and lab results, accelerating root-cause analysis for quality deviations.
Identify your best-performing batches and use them as your baseline.
Golden Batch analytics help operations teams understand exactly what good looks like, allowing them to optimize parameters and replicate success consistently.
Minimize compliance workload.
OYTEC delivers a complete validation package aligned to GAMP 5, covering IQ, OQ and PQ documentation. The solution is audit-ready under FDA 21 CFR Part 11 and EU GMP Annex 11 directly from go-live.
Aggregate KPIs from multiple production lines or sites into a single unified view.
Opcenter Intelligence Cloud supports enterprise-wide global visibility using the ISA-95 international standard as its foundational data model.

Featured Capabilities

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Unified production data layer

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.

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GxP-ready dashboard templates

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.

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Golden Batch & CPV analytics

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.

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Automated regulatory reporting

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.

Enterprise-wide KPI benchmarking

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.