Achieving 21 CFR Part11 Compliance using Exaquantum/Batch
Download TI 36J04B11-01E
|Batch Equipment Recipe|
Exaquantum/Batch is an intelligent S88-based Batch Information System. It provides verified analysis and reporting facilities that collect, store and display current and historical data from batch production, equipment and recipe viewpoints.
This enables easy user access to batch information for decision support, production planning, production scheduling, analysis, process improvement, quality and legislative compliance purposes.
|-||Faster time to market for new products
|-||Reduces material costs
|-||Increased productivity and plant utilisation
|-||Better information for improved decision making
|-||Powerful data analysis and reporting capabilities leading
to quicker batch approval
|-||Supports Six Sigma programs|
|-||Strong batch reporting platform where batch, master recipe
and equipment data for each batch is available for any report
|-||Automatic data collection is used to minimise set up time
and engineering with Yokogawa Batch control systems
|-||Batch record-keeping, reporting, monitoring and data analysis
for improving batch production
|-||High performance and value
|-||Industry standards compliance: Based upon S88 standards and
OPC Batch specification
|-||Support for use in applications subject to FDA 21 CFR Part 11|
Exaquantum/Batch is a valuable tool in batch-orientated industries allowing users to focus on Key Process Performance Indicators. It provides a web browser based analysis and reporting user interface to deliver batch-based information in support of process improvement initiatives.
Interface with OPC Enabled Control Systems
Many field proven interfaces are available for S88 and non-S88 based control systems using OPC.
Production Improvement by Six Sigma Analysis
Analyses cycle time variance and quality as batch Key Performance Indicators to identify problems in the production processes, allowing improvements to be made.
Comprehensive Reporting Tool
The comprehensive Exaquantum/Batch reporting package provides Excel-based flexible reporting, which incorporates data from batches, equipment, master recipes and trend values along with the associated alarms.
FDA 21 CFR Part 11
CFR Part 11 option is also available to provide Electronic Record/ Electronic Signature functionality.
BatchWeb is a web-based user interface similar to a web portal. On-screen menu selections allow viewing and analysis of different sets of continuously updated batch, equipment and master recipe data from both Exaquantum/PIMS and Exaquantum/Batch databases using standard charts and tables. There are a number of related views, which may be selected:
Production View: A table of useful plant information covering the recent batches Batch View: A list of batch records. Using filters, batch records may be displayed for any time period.
|Equipment View: A list of units available in the Exaquantum/Batch
database Master Recipe View: A list of the master recipes archived in the
|Report View: A list of reports that may be run. A Report Archive view is also available that provides a list of the Exaquantum/Batch reports that have been generated.|
|Exaquantum/Web Chart in Run Time||Exaquantum/Web in Run Time|
|The key features of Exaquantum/Batch are:|
|-||'Out of the box' integration with Yokogawa's CENTUM CS1000/
CS3000 Batch control systems providing immediate usability and benefits
based on the S88 standard without complex engineering and database configuration
|-||Standard analysis of data providing: Automatic calculation
and charting of cycle times for each batch, Automatically generated charts
showing unit utilisation, Comparison of batches to peer groups, Automatically
calculated performance ratings for each batch, A powerful tool for sorting
and comparing batch history data
|-||A customisable web-based user interface providing: Batch, master recipe and equipment data accessible via BatchWeb Ad-hoc web access to data without custom display generation Secure data storage with minimal client administration Optional 21 CFR Part 11 compliant functionality through the use of electronic records and signatures|