Paperless Recording for Compliance

1. Paperless Recording for Compliance More precise data Improve Operations Compliance with 21 CFR Part 11 Reduce Maintenance Improve Product Quality Electronic Recording

2. Trends in Process Recording Leo Shane Honeywell Market Development Electronic Recording

3. What is a Recorder? Paper verses Paperless Electronic Recording

4. Recorder Requirements (Pharmaceutical) • Accurately Capture Process Measurements • Characterize signals from various devices • Thermocouples, RTD’s, Voltage, and Current • Provide Operator information • Indicate current measurements • Indicate process trends and alarms • Compliance with FDA Regulations • 21 CFR Part 210 & 211 - CGMP • 21 CFR Part 11 if electronic Electronic Recording

5. Paper Recorders • Why has paper been so widely accepted? • Previously validated • Widely applied • Perceived as low risk solution • Tangible to operators • Acceptability to FDA Inspectors Electronic Recording

6. Paper Recorder Technology • Use Analog Circuitry • Older versions were direct amplifier circuit • Newer technology use digital with analog pens • Latest technology use digital printers • Ink, pens, paper, maintenance • All paper recorders require physical maintenance • Risk of data loss due to mechanical failure • Manual Access to Data Electronic Recording

7. How do Paperless Recorders Work? • Analog measurements • Signals are characterized • Digitally conversion • Analog to Digital Converter • Record Created • Time and date stamped archival record • Saved in memory and stored on media • Data is transmitted to buffer memory • Data is permanently written to storage media Electronic Recording

8. What are the benefits of Paperless Recorders ? Accuracy Operations Maintenance Quality Compliance Electronic Recording

9. Electronic Recorders Electronic Recorders Improve your Plant Operations • Electronic Data Storage • Secures process and quality control data • Data can be copied on to server for safe keeping • Floppy can be removed and inserted without loss of data • Tamper proof encryptedfiles • Encryption prohibits data alteration. • Data is recorded as it is • Data is read using graphic software or using the recorder’s replay function • Data can be exported to other Windows applications • Eliminates the cost of special paper, ink, and pens • 1.44 Megabyte floppy disks, Zip, or 120 Megabyte Superfloppy • Eliminates frequent operator intervention • No pens to go dry • No mechanical pen mechanism to be serviced • No paper to replace or inventory Electronic Recording

10. Electronic Recorders Electronic Recorders Improve your Plant Operations • Electronic Display • Operators see it as it happens • Trends are plotted as they develop • Alarm annunciation helps operators identify problems quickly • Operators see the process more clearly • High contrast, bright, Color LCD Display for viewing at a distance, wide viewing angle • Color coded trend lines and bold text make data more legible • Tailor the displays to match your process • A library of Trend, Bar, Control Loop, Data Summary, and Diagnostic display formats are selectable • Up to ten displays can be configured and assigned • Display configurations are independent of the history schedule Electronic Recording

11. Electronic Recorders Electronic Recorders Reduce the Cost of Implementation • Flexible • Maximize connectivity with less equipment • The Electronic Recorder characterizes all signals • Universal Analog Inputs eliminate the need for converters and additional hardware • Directly connect to various RTD’s, Thermocouples, Pyrometers, • Humidity and Oxygen Probes are supported • Math characterizes non-linear signals Electronic Recording

12. Electronic Recorders Electronic Recorders Improve your Plant Operations • Advanced functions help operators • Calculate and record performance values • Full Function Math supports specialized performance equations • Free format math includes logarithmic calculations, natural logarithms, absolute values, exponential expressions, scientific notation, and square root. • Specialized Math Functions: • F0 for pasteurization (FDA) • Continuous Emissions Monitoring Rolling Average(EPA) • Relative Humidity • Mass flow Electronic Recording

13. Electronic Recorders Electronic Recorders improve decision making and customer satisfaction • Data Acquisition and Analysis • Production Information is more precise • Measurements are more accurate • Data is captured directly from instruments • Automated Totalization of flows and rate calculations • Trend Analysis Software • Analyze process history on a PC from a disk or over the Net • Trend data, Bar graphs, and Tabular reports can be generated from trend analysis software • Scroll, zoom, and search tools help manufacturing to identify and remedy problems • Audit Trail documents operator actions and process events affecting the process • Alarm history links process upsets to product quality Electronic Recording

14. Electronic Recorders Electronic Recorders improve decision making and customer satisfaction • Data Acquisition and Analysis • Electronic reports speed up decision making and improve quality awareness • Transfer production data to Excel spreadsheets • Email reports to clients and co-workers • Post results on the company Intranet or Internet • Communications Option enables data transfer to plant information systems • Ethernet10BASE T and 10BASE 2, TCP/IP communications. • FTP for transfer or Archive data and SETUP files. • Web Browser access to critical recorder parameters. • Compatible with supervisory control systems Electronic Recording

15. Improving the Integrity of the Data Compliance with 21 CFR Part 11 Key Issues Data Integrity: • Accurate & Authentic • Identification of Users • Authorized access, Security • Prevent falsification • Audit trail, Traceable • Human Readable Electronic Recording

16. Specifying a Paperless Recorder Defining the Requirements “Closed Systems” Electronic Recording

17. Closed System The Regulation: Subpart A, Section 11.3 (b), (4) “Closed System” means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. The Specification: The recorder will be installed in a Closed System environment as defined by 21 CFR Part 11. The recorder shall at minimum meet the requirements of Subpart B, Section 11.10. Electronic Recording

18. 21 CFR Part 11- Closed System The Regulation: Subpart B, Section 11.10: Controls for Closed Systems “……to ensure the authenticity, integrity, and when appropriate the confidentiality of electronic records, and can ensure that the signer cannot repudiate the signed record as not genuine.” The Specification: Data shall be time and date stamped in a digitally encrypted format that ensures data authenticity and integrity in a consistently accurate fashion. Encrypted records shall include CRC error checking that will detect alteration or falsification of data. Electronic Recording

19. 21 CFR Part 11 - Closed System The Regulation: Section 11.10 (b) “The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency (FDA).” The Specification: Data Analysis Software shall directly convert encrypted records to human readable form and create reliable and accurate electronic and human readable copies. Tools may permit the addition of annotations; but, not modification or deletion. Electronic Recording

20. 21 CFR Part 11 - Closed System The Regulation: Section 11.10 (d) “Procedures and controls shall limit system access to authorized individuals.” The Specification: Electronic Recorders shall be equipped with security functions that limit access to authorized personnel. The security system shall retain operator profiles with established permissions and shall identify each person that accesses the recorder. Electronic Recording

21. 21 CFR Part 11 - Closed System The Regulation: Section11.10 (e) “Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained at least as long as that required for the subject electronic records and shall be available for agency review and copying.” The Specification: All operator actions, process events, system diagnostics, alarms, etc. shall be logged to the audit trail by the recording system. Each event shall be time and date stamped automatically by the system. Electronic Recording

22. Access to Process Information Electronic Recording

23. Paper Access Electronic Recording

24. Access recorders through the Plant Wide Local Area Network or from the Web. Multi-level, multi-user password protection allows access by various departments with security. Electronic Access to Trend Data Web Browser Internet Minitrend Recorders Directly Connected to Ethernet LAN Plant Wide Local Area Network Quality Dept. Multitrend Plus Maintenance Dept. Multitrend Minitrend Trend Server Pro Trend Manager Pro Minitrend Teletrend Local Instrument Network Local Instrument Network

25. Electronic Recorders Providing Operators, Supervisors, Managers, Quality Controllers, and Engineers with the tools to improve Manufacturing Compliance. Improving your Operations Automating your Data Storage Complying with 21 CFR Part 11 Reducing your Maintenance Improving Product Quality Electronic Recording