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Reducing Maintenance Jon Welsh
and Calibration Costs Application Specialist
through Automation Laboratory Informatics
using
Agilent Enterprise Edition OQ and
OpenLAB ECM
1
Confidentiality Label
November 14, 2012
Using ECM to the fullest
•
ECM document management tools and BPM
Manage SOP’s
– Automate lifecycle
– Multi-level review and approval
– Notify users of any changes
•
Manage MSDS
– Secure storage with easy linking
– Web access and searching
•
Automate instrument IQOQ procedures
– Reduce downtime
– Instant Web access to qualification status and results
– Automated reproducible procedures
•
Other Documentation
– Training Records
– Instrument Logs
MS Office
•
2
PDF
Confidentiality Label
November 14, 2012
The Real Costs of Maintenance and
Calibration
Hard Costs:
•
Test Execution
•
PM & OQ Parts
Soft Costs:
•
Resources for
review & approval
•
SOP/protocols generation & maintenance
•
Records management
•
Downtime
•
Lab productivity, cost / sample…
Hard Costs
20%
Soft Costs
80%
Source: Agilent Technologies Customer Composite
The Real Costs of Maintenance and
Calibration
Hard Costs:
•
Test Execution
•
PM & OQ Parts
Soft Costs:
•
•
•
Resources for
review & approval
Source
% of Total Costs
Test Execution
5-15%
PM & OQ Parts
5-10%
SOP/Protocol Generation &
Maintenance
10-20%
Report review & approval
20-40%
Report/Records management
10-15%
Down Time (utilization)
20-50%
SOP/protocols generation & maintenance
Records management
Source: Agilent Technologies Customer Composite
•
Downtime
•
Lab productivity, cost / sample…
Typical Lab Downtimes Due to
Instrument Qualification
30 Instruments
Department
Number of
Instruments
Average downtime per
instrument due to PM
and OQ delivery
Average downtime per
instrument due to report
review and sign-off
Total downtime
per instrument
Total down time
QC
20
1 day
5 days
6 days
120 days
Development
10
1 day
10-15 days
11-16 days
110-160 days
TOTAL
230-280 days
Typical Lab Downtimes Due to
Instrument Qualification
30 Instruments
Department
Number of
Instruments
Average downtime per
instrument due to PM
and OQ delivery
Average downtime per
instrument due to report
review and sign-off
Total downtime
per instrument
Total down time
QC
20
1 day
5 days
6 days
120 days
Development
10
1 day
10-15 days
11-16 days
110-160 days
TOTAL
230-280 days
Typical Lab Downtimes Due to
Instrument Qualification
30 Instruments
Department
Number of
Instruments
Average downtime per
instrument due to PM
and OQ delivery
Average downtime per
instrument due to report
review and sign-off
Total downtime
per instrument
Total down time
QC
20
1 day
5 days
6 days
120 days
Development
10
1 day
10-15 days
11-16 days
110-160 days
TOTAL
230-280 days
Cost?
•
•
•
•
Lost revenue – cost per sample
Loss of personnel productivity
Cost of additional instruments
Other?
Typical Lab Downtimes Due to
Instrument Qualification
30 Instruments
Department
Number of
Instruments
Average downtime per
instrument due to PM
and OQ delivery
Average downtime per
instrument due to report
review and sign-off
Total downtime
per instrument
Total down time
QC
20
1 day
5 days
6 days
120 days
Development
10
1 day
10-15 days
11-16 days
110-160 days
TOTAL
230-280 days
Cost?
•
•
•
•
Lost revenue – cost per sample
Loss of personnel productivity
Cost of additional instruments
Other?
Can Agilent help reduce the costs?
Laboratory Process Automation
+
Enterprise Edition OQ
LSCA Software and Informatics
Agilent Restricted
Laboratory Process Automation
+
Enterprise Edition OQ
=
Enterprise Content Management (ECM)
+
Business Process Management (BPM)
LSCA Software and Informatics
Agilent Restricted
Laboratory Process Automation
+
Enterprise Edition OQ
=
Enterprise Content Management (ECM)
+
Business Process Management (BPM)






Customized OQ Test Conditions
Electronic OQ
OQ Report Interrogation
Automated Report Routing
Electronic Signature
Automated Report Archival
LSCA Software and Informatics
Agilent Restricted
Agilent OpenLAB Software Portfolio
OpenLAB ECM
OpenLAB CDS
OpenLAB ELN
Scientific Data Management
Chromatography Data System
Electronic Lab Notebook
Scientific Data Management
•
•
•
•
•
•
•
•
•
Business Process Management
Data Archiving
Instrument Vendor Neutral
Time Stamp/Audit Trail
Report Capture
Viewers, Filters, Converters
E-Signatures
Regulatory Compliance
TNF Conversion (LTDA)
WorkStations, Client-Server
•
•
•
•
ChemStations, EZChrom Elite
Multi-Vendor
OpenLAB ECM Intelligent Reporter
Regulated and Non-Regulated
Modes
• Web-Based Options
Capture, Organize, Collaborate
• Smart, high productivity alternative
to paper notebooks
• IP Protection and Compliance
Features
• Simplifies and accelerates R&D
• Smart Data Import and Dynamic
Forms
• Simple Web Based Client
• Analytical Request Module
Agilent OpenLAB Software Portfolio
OpenLAB ECM
OpenLAB CDS
OpenLAB ELN
Scientific Data Management
Chromatography Data System
Electronic Lab Notebook
Scientific Data Management
•
•
•
•
•
•
•
•
•
Business Process Management
Data Archiving
Instrument Vendor Neutral
Time Stamp/Audit Trail
Report Capture
Viewers, Filters, Converters
E-Signatures
Regulatory Compliance
TNF Conversion (LTDA)
Instrument Control and Reporting
•
•
•
•
•
•
ChemStation & EZChrom Elite
Multi-Vendor
Workstations and Distributed
OpenLAB ECM Intelligent Reporter
Regulated and Non-Regulated
Web-Based Options
Capture, Organize, Collaborate
• Smart, high productivity alternative
to paper notebooks
• IP Protection and Compliance
Features
• Simplifies and accelerates R&D
• Smart Data Import and Dynamic
Forms
• Simple Web Based Client
• Analytical Request Module
Agilent OpenLAB Software Portfolio
OpenLAB ECM
OpenLAB CDS
OpenLAB ELN
Scientific Data Management
Chromatography Data System
Electronic Lab Notebook
Scientific Data Management
•
•
•
•
•
•
•
•
•
Business Process Management
Data Archiving
Instrument Vendor Neutral
Time Stamp/Audit Trail
Report Capture
Viewers, Filters, Converters
E-Signatures
Regulatory Compliance
TNF Conversion (LTDA)
Instrument Control and Reporting
•
•
•
•
•
•
ChemStation & EZChrom Elite
Multi-Vendor
Workstations and Distributed
OpenLAB ECM Intelligent Reporter
Regulated and Non-Regulated
Web-Based Options
Capture, Organize, Collaborate
• Smart, high productivity alternative
to paper notebooks
• IP Protection and Compliance
Features
• Simplifies and accelerates R&D
• Smart Data Import and Dynamic
Forms
• Simple Web Based Client
• Analytical Request Module
Header
Operator ID
Run Date
Method
Method revision
Instrument
Instrument ID
Firmware version
Make
Model
Sample
Sample ID
Sample Type
Sample Source
Traditional role of ECM in the Lab
•Capture
Manage
Store
Deliver and
Preserve Content
Corporate RecordsProject
Research Data
Management
Electronic Notebook
Partners,
Customers
LIMS
CDS
SOPs
Validation Plan
Manufacturing
Batch Records
Clinical Trials
Instrument Data, Lab Reports
Marketing Collateral
Changing role of ECM in the lab
Start
Success
Success
Success
Success
Success
Success
Integrated into Laboratory Workflow
Success
Success
Success
Success
End
… Workflow Automation
Intelligent Reporting
Cross Vendor Cross Application
Flagging out of spec
OpenLAB Enterprise Content Management
Automating Laboratory Processes
Data
Management
Asset
Management
Document
Management
Critical lab
Management
Versioning
Time-stamps
Instrument
log book
MSDS
21CFR 11
Any electronic
data or record
Maintenance
and calibration
SOPs
Scheduled
activities
Data filters
Utilization
reporting
Excel
remediation
BPM
Long-term
archiving
Compliance
records
Indexing
ECM
Training
records
OLIR
RSME
OpenLAB Enterprise Content Management
Automating Laboratory Processes
Data
Management
Asset
Management
Document
Management
Critical lab
Management
Versioning
Time-stamps
Instrument
log book
MSDS
21CFR 11
Any electronic
data or record
Maintenance
and calibration
SOPs
Scheduled
activities
Data filters
Utilization
reporting
Excel
remediation
BPM
Long-term
archiving
Compliance
records
Indexing
ECM
Training
records
OLIR
RSME
Instrument Maintenance & Calibration
Process
SOP
Scheduling
PM and OQ
Remove
instrument
from service
Perform and
Document
PM and OQ
Review and
sign-off
Document /
Record
management
Instrument Maintenance & Calibration
Process
Using ACE, a
protocol for
SOP
PM and OQ is
developed.
Using BPM, a
process is
Scheduling
designed
to
PM
and
OQ
schedule the
PM and OQ
events.
Using BPM,
the instrument
status is
Remove
instrument
changed
from
from
service
“Ready” to
“Maintenance
Due”.
Using the
protocol
Perform and
produced by
Document
ACE,
theOQ
PM
PM and
and OQ is
performed.
Using BPM,
the PM and OQ
Review
reports and
are
sign-off
routed for
review and
approvals.
The approved
ACE
report is
Document
/
indexed, and
Recordin
stored
management
ECM’s secure
repository.
Putting it all together…
LSCA Software and Informatics
Agilent Restricted
Extracting information from ACE Reports
Enterprise Edition OQ
Report contains detailed
information about the testing
performed.
When coupled with OpenLAB
ECM / BPM, any of this
information can be used to
make decisions in a business
process.
Extracting information from ACE Reports
Extracting the Information
Using the PDF extraction tool in
OpenLAB ECM, individual
pieces of information can be
extracted from the report.
For example; test results,
instrument name, date of
testing…
The ACE Report in OpenLAB ECM
Uploading to ECM
Pertinent information are
extracted and stored as part of
the file’s metadata (any
information that describes the
file or its contents).
Automating Review and Approval
Business Process Management
The BPM component of OpenLAB
ECM, the ACE report is intelligently
routed:
• PASS result  review and approval
• FAIL result  further action
Automating Review and Approval
Email Notification
If the ACE Report contains an
overall PASS value, an Email
notification is sent to required
approvers (serially or in parallel)
Text extracted from the ACE
Report can be included in the
email text. For example,
Instrument ID
Automating Review and Approval
User Action
This activity delivers the report
to a user or group of users for
review and approval.
The reviewer electronically
signs the document as part of
the process.
If the review isn’t complete
within a configurable time frame,
email reminders are sent to the
user and their manager.
In the Event of a Failure
Email Notification
If the ACE Report contains an
overall FAIL value, an Email
notification is sent supervisors
and end users (serially or in
parallel)
Details of the specific failure can
be included in the email text.
Access to instrument can be
locked out*
In the Event of a Failure
User Action
When an ACE qualification fails, the
process can ask a user to perform an
action; for example:
• Remove instrument from service
• Schedule instrument maintenance
• Contact Agilent Service
• Review recent instrument activity for
affected results
Automating Scheduling
Sleep / Wait
Once the report is approved, the
process sleeps until the next
scheduled maintenance.
The new report goes into ECM as
a new version and the process
begins again.
Comparison with Lab Automation
30 Instruments
Days of Instrument Downtime (per
instrument)
Electronic Protocol with BPM
Automation
Paper based manual process
0
5
Paper based manual process
OQ/PM Delivery
Report Review and Sign-off
1
12
10
15
Electronic Protocol with BPM
Automation
1
4
Typical Lab Downtime Due to Qualification
30 Instruments
Department
Number of
Instruments
Average downtime per
instrument due to PM
and OQ delivery
Average downtime per
instrument due to report
review and sign-off
Total downtime
per instrument
Total down time
QC
20
1 day
3 days
4 days
80 days
Development
10
1 day
3 days
4 days
40 days
TOTAL
120 days
Benefit
VS. 230-280 days
• Reduce downtime due to report review and sign-off by 50-75%
• Bring instruments online in 3-5 days in QC and Development
• Increase instrument availability by 110-160 days
Automated Calibration and Maintenance Tool
What do I need to make this work?
• OpenLAB ECM (version 3.4.1 is best)
• OpenLAB BPM add-on (Version 3.4.1 is best)
• Agilent to deliver the instrument qualification
using the Enterprise Edition OQ using the ACE
tool
• BPM template (MS Visio)
• ACE PDF template