Environmental Monitoring System... with data security and Store & Forward Secure electronic data Self healing data archiving Dynamic reporting
Pharmaceutical Environmental Quality Monitoring System Control and monitoring of storage and production environments are very important within the Pharmaceutical Industry. The FDA, MHRA, EMEA and other regulatory bodies require accurate measurement and storage of environmental parameters and, if the storage medium is electronic, the methods used must comply with 21 CFR Part 11. Data Logging Data logging is a key requirement for EMS systems. 21 CFR Part 11 requires that logged data will be tamper resistant and will include critical environmental parameters (temperature, humidity, pressure, particulate sizes, etc), with audit trails including: Accurate time and date stamps Alarms and events User actions and details (e.g. setpoint changes) User notes Electronic Signatures Login/Logout Eurotherm EMS systems log plant data to tamper resistant files and SQL relational databases. Data logging can be offered as: Local logging (Tamper resistant file with direct SQL interface) Central logging (SQL database) Local and central logging (Tamper resistant files and SQL database) The availability of logged data can be significantly increased by the local and central logging option. This allows data collection in multiple devices to further protect vital plant data. Time synchronisation is included to ensure accurate time and date stamps, as required by 21 CFR Part 11, to a known clock source. The EMS system offers provisions for electronically copying data for archive and export facility to common packages (e.g. Excel, Word, PDF, etc.) for viewing of secure records in human readable format. In addition to proprietory tamper resistant files, Eurotherm EMS offers a direct SQL interface that facilitates easy integration to other data historians. Other features of the system include: Power and network recovery automatic procedures FTP protocol to transfer to central server Scheduled transfers The system can be configured to provide logging for non-critical parameters including: System events Equipment failure Equipment performance and maintenance Energy usage Eurotherm 21 CFR Part 11 compliant data files with direct SQL interface supporting true Store & Forward technology 21 CFR Part 11 Compliance Eurotherm proprietary tamper resistant data files are generated in a binary, compressed and check- summed format. To assist data integrity the standard Eurotherm visualisation tools reject invalid / altered (incorrectly check-summed) records. Audited Data Auditor features on Eurotherm products have been specifically designed to meet the requirements of the FDA 21CFR Part 11 document for Electronic Records and Electronic Signatures. Data is held in both Human Readable and Electronic form. Electronic data can be viewed, analysed and printed off-line using the secure Review package. The Auditor, besides logging process values, provides secure, product generated, Audit trails. The Audit trail records all actions taken by the operators. Direct SQL interface Eurotherm data files are identified with.uhh suffix. These files meet the stringent requirements of regulatory bodies such as the FDA, EMEA, MHRA etc. However with the advent of Electronic Batch Records there is a need for a more open data structure. As always the Eurotherm approach to problems such as these results in a complete solution that meets all user and regulatory expectations. The.uhh files now have a direct SQL interface that is achieved through a series of Stored Procedures. The result of this approach is to: Retain the original data integrity for 21 CFR Part 11 compliance Operate as a high speed data provider through Stored Procedure queries Provide a direct interface to any SQL based historian Regular automatic update of SQL database, forward procedure Opens the data search engine to provide a more comprehensive query subset Ensure full Store & Forward support direct from the sensor level 2 Environmental Monitoring System Brochure
Self Healing Data Archiving with Store & Forward Store & Forward is a self healing 21 CFR Part 11 data archiving system that continuously stores data locally and is regularly forwarded to the configured server. This data is therefore available to update a historian package. This results in secure electronic recording with total data integrity. Store, Forward and Backfill Normal Comms Normal Operation Process value and audit trail sent directly to Central Lost Data Missing data in caused by Communications failure PC failure failure Visualisation Data Self Healed Store, Forward & Backfill action Identify missing data period Retrieve data from Eurotherm tamper-resistant file Backfill the control with missing data PV alarms audit trail messages Identifies lost data Back fill data Retrieves data Store & Forward Data Server Tamper resistant files Operations Viewer Data Realtime data Back up data.uuh files OPC Client Operations Server EYCON Visual Supervisor T2750 PAC versadac 6000 Series Graphic Recorder Environmental Monitoring System Brochure 3
Secure Electronic Data In addition to meeting the exacting requirements of generating regulatory (FDA, EMEA, etc) compliant records, Eurotherm solutions provide significant benefits by including redundant logging with Store & Forward security. This ensures that data integrity is maintained through the implementation of fault tolerant features. Logging parameters Regular Time Based Process Variable (Actual max, min, average) For example: Temperature Pressure Particle count Relative Humidity Speed Door Status... plus any other process parameter Event Based Channel Alarms User event messages Operator notes Log in/log out Batch start/stop Operator actions Electronic signatures Logging options Event Based Continuous trace Batch Start/stop Continuous (Sub phases or sub batches) 21 CFR Part 11 Compliant Signed audit trails Data Presentation Trend chart and spreadsheet based Absolute or relative time Batch or Sub Batch data search by: Absolute date & time Relative date & time Batch name Sub Batch name Audit Trail Repository ASCII CSV Repository Review.UHH 21CFR Part 11 compliant Chart Replay Screen OPC ASCII.UHH SQL OPC Technology Neutral Format Query SQL Live Data Optional Interfaces Store & Forward Review Screen Secure Batch Release Operator signed and authorised batch and continuous records Reviewed Approved Released Data Security 21 CFR Part 11 compliant binary encoded read-only files Auto-archive to nominated server Secure embedded audit trails Electronic signing and authorising Batch Approval Screen 4 Environmental Monitoring System Brochure
Redundant OPC Servers Redundant Data Acquisition at Local Level Operations Viewer Data Ethernet OPC Client Operations Server EYCON Visual Supervisor Ethernet T2750 PAC versadac 6000 Series Graphic Recorder Industry Standard PLC Batch Recorded Data Screen Batch Report Screen Environmental Monitoring System Brochure 5
Dynamic Reporting Eurotherm offers a range of reporting utilities to generate reports automatically or on demand. For each report utility users will be able to use the standard library report or create their own custom reports. Advanced Reporting Dream Report software from Eurotherm is an integrated reporting solution for industrial automation. It is designed to be the simplest solution to extract data from almost any data source and automatically provide reports to anyone, anywhere. Built on modern technologies, Dream Report software fits perfectly for both continuous and batch process applications. Standard Reporting Eurotherm Review is a PC based Software package that allows the display and printing of archived data files from the Eurotherm range of Data Acquisition units. Archived Data files can be transferred to the Review database in one or more ways, either by using a network connection or reading directly from the units' removable media. Once transferred the data can be used to recreate the charts, and spreadsheets for viewing and if necessary printing. 6 Environmental Monitoring System Brochure
Data Management, Acquisition and Control Products Supervisory System Operations Server/Viewer: provides a single integrated view of your system. The software enables the engineers, supervisors, managers and operators to view and communicate with the workings of your entire operation through graphical representations of your production process. The software provides a host of features including distributed alarm handling, distributed historical data, centralised alarm printing, etc. Aids 21 CFR Part 11 requirement Engineered displays tailored to meet the needs of BMS/EMS System wide availability of information Client Server architecture with master/backup servers Uses Wonderware InTouch Information Manager: combines the power and flexibility of a relational database with the speed and compression of a real time historian package. The information manager is up to 300 times faster than a conventional relational database but only uses 2% of the disk space normally required by a conventional relational database. Aids 21 CFR Part 11 requirement Captures and stores all EMS data Realtime and historical data can be made available to enterprise Minimises storage space and controls volume of data retrieved Uses Wonderware T2750 Programmable Automation Controller: offers DCS functionality and much more while being extremely cost effective. Capable of continuous analog, logic and sequential control, and redundant 21 CFR Part 11 logging is designed to address all the needs of your BMS/EMS Aids 21 CFR Part 11 for electronic records Cost effective redundancy Redundant logging Continuous and sequential control Hot swap I/O Alarm handling Wide range of I/O: PRT, TC, 4-20mA, 0-10V, mv, etc. Eurotherm Eycon TM Visual Supervisor: provides innovative, multi-function control, recording and visualisation bringing Eurotherm s expertise in control, data acquisition and process automation into a single process management unit. Aids 21 CFR Part 11 requirement Logging with Store & Forward Accurate continuous and sequential control Alarm handling Communications including Modbus, Modbus TCP, OPC, Profibus Recorders: adaptable functionality incorporated into the 6000A instruments will meet the most demanding of solution requirements. With their ease of use and configuration, you can be sure to maximise your return on investment. Aids 21 CFR Part 11 requirement Multiple logging media Remote viewing with Bridge Maths function The versadac scalable recorder offers a versatile solution for data recording at point of measurement. Comprehensive security and data integrity make it ideal for use in regulated industries. Sensors: communicate measurement and status information from the process to the control and monitoring modules of the EMS system. Sensors supported by Eurotherm solutions include: Temperature Luminescence (light level) Gas Level HVAC healthy status Relative humidity Particle counter Air pressure or differential pressures and many others Environmental Monitoring System Brochure 7
Eurotherm Limited Faraday Close, Durrington, Worthing, West Sussex, BN13 3PL Phone: +44 (01903) 268500 Fax: +44 (01903) 265982 www.eurotherm.com/worldwide Scan for local contacts Eurotherm by Schneider Electric, the Eurotherm logo, Chessell, EurothermSuite, Mini8, Eycon, Eyris, EPower, EPack, nanodac, piccolo, versadac, optivis, Foxboro and Wonderware are trademarks of Schneider Electric, its subsidiaries and affiliates. All other brands may be trademarks of their respective owners. All rights are strictly reserved. No part of this document may be reproduced, modified, or transmitted in any form by any means, nor may it be stored in a retrieval system other than for the purpose to act as an aid in operating the equipment to which the document relates, without the prior written permission of Eurotherm Limited. Eurotherm Limited pursues a policy of continuous development and product improvement. The specifications in this document may therefore be changed without notice. The information in this document is given in good faith, but is intended for guidance only. Eurotherm Limited will accept no responsibility for any losses arising from errors in this document. Document Number HA030142 Issue 2 July 2015 Copyright Eurotherm Limited 2015