MES
A Manufacturing Execution System links ERP planning with the production floor. Poor integration leads to data gaps, while paper batch records cause compliance issues, transcription errors, and release delays.
Paperless Batch Record Execution
Enforced step sequencing
The MES shows each batch step in order and requires confirmation before the next step, preventing out-of-sequence work and deviations from in-performance.
Real-time operator confirmation capture
Operator confirmations, weigh and dispense logs, and in-process control results are recorded at the point of performance, creating a contemporaneous record that meets ALCOA+ standards.
Supervisory electronic sign-off
Critical batch steps need supervisory electronic countersignature before proceeding, enforcing dual operator verification required by GMP for high-risk processes.
Electronic Weigh and Dispense
Barcode-verified material identity
Materials are verified by barcode scan against the batch formula before dispensing, preventing wrong materials, grades, or ingredients that paper systems miss.
Balance integration for quantity capture
Actual dispensed quantities are captured from connected balances, removing manual weight entry and reducing transcription errors common in GMP manufacturing.
Dispensing record integration
Complete dispensing records integrate with the batch record and ERP for material usage with verified quantities and operator identities, eliminating manual compilation.
Equipment Integration and Process Parameter Capture
Automated process parameter capture
Parameters from bioreactors, tablet presses, and fluid bed, and filling lines are captured directly via integration, creating objective, time-stamped records without manual entry.
Critical process parameter limit monitoring
Critical process parameters are monitored in real time, triggering alerts and batch record flags if they exceed specification limits during production.
Equipment qualification status enforcement
The MES blocks use of equipment outside its qualification state at the point of operation and records compliance for GMP inspection verification.