Product/Service

Electronic Batch Records

Source: ABB Automation - Pharmaceutical
ABB's Electronic Batch Record (EBR) system replaces paper batch process records with a complete, paperless, electronic batch record
ABB's Electronic Batch Record (EBR) system replaces paper batch process records with a complete, paperless, electronic batch record with electronic signature. It complies with FDA 21 CFR, part 11.

Features:

  • ABB's EBR provides user configurable recipes for weigh and dispense and batch management.
  • ABB's EBR steps the operator through the weigh out and manufacturing process. Values specified in the configured recipe are used to validate the actions taken and to validate values entered for the batch. Deviations are recorded at the time they occur.
  • It is a scaleable solution, which may be used by itself, integrated with existing systems or integrated as a turnkey solution.

    What it means to you:
    Improved Recipe Management
    Tracking by lot, testing of material expiration dates, testing of material release states, reporting of actual consumption and reporting of actual production improves recipe management.
    Improved Quality
    Guiding the operator through the manufacturing steps, validating values at the point of entry and validating lot numbers improves batch quality and batch consistency.
    Reduced Transcription Errors
    Using bar codes and direct readings from weigh scales, DCS, PLC, LIMS, MMS and SCADA systems minimize transcription errors.
    Reduced Deviation Follow-up Time
    Identifying and recording variance and deviations at the point of entry reduce the time spent following up deviations
    Reduced Time for Batch Release
    Reporting exceptions and early availability of deviation information speed up batch review and release.

    ABB Automation - Pharmaceutical, 1175 John Street, West Henrietta, NY 14586. Tel: 716-273-7246; Fax: 716-273-7014.