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

2
Trends in Process Recording

• Leo Shane
• Honeywell
• Market Development

3
What is a Recorder?

• Paper verses Paperless

4
Recorder Requirements (Pharmaceutical)

• Accurately Capture Process Measurements
• Characterize signals from various devices
• Thermocouples, RTDs, 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

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

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

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

8
What are the benefits of Paperless Recorders ?

• Accuracy
• Operations
• Maintenance
• Quality
• Compliance

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 encrypted files
• Encryption prohibits data alteration.
• Data is recorded as it is
• Data is read using graphic software or using the
  recorders 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

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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

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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 RTDs, Thermocouples,
  Pyrometers,
• Humidity and Oxygen Probes are supported
• Math characterizes non-linear signals

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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

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

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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
• Ethernet 10BASE 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

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

16
Specifying a Paperless Recorder

• Defining the Requirements
• Closed Systems

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.

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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.

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.

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.

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.

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Access to Process Information
23
Paper Access
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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