Solutions > rapidPharma | Automsoft

By: Automsoft  05/12/2011
Keywords: Control Systems, reporting tool, electronic Signatures

Automsoft are recognized leaders in the process life sciences sector. rapidPharma by Automsoft is a robust and powerful distributed data historian capable of high-speed data capture and retrieval of pharmaceutical process and batch data empowering plant-wide data intelligence and production optimization.

rapidPharma centralizes and serves pharmaceutical process data sourced from enterprise-wide manufacturing control systems including:

  • Lab Information Systems
  • Warehouse Control Systems (WHSE)
  • Batch Execution Systems (BES)
  • Process Logic Controllers (PLC)
  • Supervisory Control and Data Acquisition systems (SCADA)

    In addition to rapidHistorian’s key application features, rapidPharma also incorporates the following life sciences industry-specific features:

  • Batch management & optimization: rapidPharma interfaces with BES attached to SCADA or MES enabling disparate batch data to be centralized. rapidPharma’s Batch Adaptor simplifies data retrieval and storage of complex S88 batch data such as procedures, recipes, alarms, phases and operations. Technicians can perform bespoke batch analysis reports, review constraints, conduct batch comparisons and identify optimum recipes for future replication.
  • FDA 21 CFR Part 11 Compliance:
    • Security: rapidPharma leverages operating system level security sub-systems to enable administrators to control and manage user authentication and authority checks.
    • Audit Trail: rapidPharma records each human interaction with the rapidHistorian system in a discrete, tamper-proof, self-auditing Audit Database. Administrators can use rapidPharma’s Audit Reporting Tool to generate completely traceable audit records of all interactions.
    • Electronic Signatures: Using digital signature technology, rapidPharma enables the application of electronic signatures (comprising user name, time and purpose of signing) which can be applied to reports.
  • FDA PAT alignment: rapidPharma supports the FDA Process Analytic Technology framework by enabling multivariate data integration, data and process analytical chemistry tools, process and end-point monitoring and control, as well as an interface with continuous improvement and knowledge management tools.
  • FDA 21 CRF Part 11 Features:
    • Security: Control and manage user authentication and authority checks.
    • Audit Trail: Generate completely traceable audit records of all application/data interactions (by user, date, interaction type).
    • Electronic Signatures: Apply electronic signatures (comprising user name, time and purpose of signing) to reports.
    • Powerful distributed data historian
    • Enterprise data aggregation & centralization
    • Calculation Engine, root-cause analysis & predictive modeling
    • Centralized report, trending & graphing tools
    • Alarm & event management
    • KPI monitoring & OEE analysis
    • Real-time plant monitoring & asset management
    • Low IT administration
    • Secure data, user authentication & electronic signatures

Keywords: Control Systems, Data Aggregation, electronic Signatures, High-speed Data, reporting tool, User Authentication,

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