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The world leader in serving science
Using LIMS to Drive Data Integrity in a Regulated EnvironmentDr David HardyTechnical Solutions ManagerDigital Sciences
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Data Integrity Definitions
Data Integrity: The degree to which a collection of data is complete,
consistent and accurate.FDA Glossary of Computer Systems Software
Development Terminology (1995)
Data Integrity: The extent to which all data is complete, consistent and
accurate throughout the data lifecycle. MHRA Guidance for Industry on Data Integrity
2015
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Why is Data Integrity Important?
Consider the Consequences
إ.د £ $ س.ر €
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Data Integrity is a Major Regulatory IssueGlobal issue but what are the causes?
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Data Integrity is a Major Regulatory IssueGood Intentions – Soon Overwhelmed
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ALCOA+
Attributable — Who performed an action & when?
Legible — Can you read the data file & written entries throughout the life cycle?
Contemporaneous —Documented at the time of the activity.
Original — Original record or a certified copy.
Accurate — No errors or editing without documented amendments.
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ALCOA+
Complete - All data including any test, repeat or reanalysis performed
Consistent - All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence
Enduring - Recorded in laboratory notebooks or in validated systems
Available - Can be accessed for review and audit or inspection over the lifetime of the record
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Regulated Environments
The world leader in serving science
Data Integrity - What’s the Solution?
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Informatics Aids Data Integrity Compliance
Lab Management
Complete Laboratory Management
Sample, test, & result management
Management of lab personnel & resources
Process optimization & standardization
LIMS
Data Visualization
Visualize without original application
Laboratory data archival, retrieval and preservation
Support for >180 instrument data formats
Vendor independent XML for long term storage
Raw Data
Procedural ExecutionDrives users through a process
in a stepwise fashion
Configuration, not customization to deploy methods and SOPs
Connects to the general LIMS capabilities to provide an
integrated solution
Laboratory Execution
Methods & SOPs
Thermo Fisher Scientific SampleManager LIMS provides a complete picture of your laboratory data from the original raw data to final results
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Data Integrity Issue: Adhere to Your SOP
Maps your SOP’s (methods) electronically to
aid execution and compliance
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Data Integrity Issue: Adhere to Your SOP
Background information and prerequisites are shown before starting
the execution
Lab Execution details can be added
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Instrument Selection
Instructions per step
Different prompts per step
Step wise approach
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Drift Check Result Entry
Result Entry, manual or from an
instrument
Limit checks done during execution, includes MLP
checking
Hazard signs shown during execution
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Calculations and Final Result
eSignature configuration per step
Calculations done (using values from
previous steps)
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Review Execution
Review by exception
Accept or Reject steps or overall execution
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Data Integrity Issue: Unofficial Testing
Automate your laboratory decisions and improve your ability to respond to the needs of your business
Graphically define your lab process in the system
SampleManager LIMS manages the complete laboratory workflow ensuring testing procedures are followed correctly
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SampleManager SDMS provides secure, future-proofed data archival & management.
.
Data Integrity Issue: Lack of Complete, Lost or Deleted Data
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Data Integrity Issue: Lack of Complete, Lost or Deleted Data -SDMS Solution
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Data Integrity Issue: Failure to Sign/Approve Tests or Reports
SampleLogin
TestAssignment
ResultEntry
ResultApproval
(Supervisor)
TestApproval(Manager)
Batch/SampleApproval
(QA)
SampleReceipt
e CoA
ERP
Instrument Data
Capture
Labels
ScanSample
View ProceduresOperator Approval Control
Instrument Calibration ControlStock Not Expired & Usage
Control
ViewInstrument Data
OOS
ERP
Lot DispositionBatch Records Update
LIMS manages the complete review and approval process to ensure correct sign off has occurred
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Data Integrity Issue: Access to Data via the Operating System
Data Systems (CDS, MS, FT/IR, etc.)Data Systems (CDS, MS, FT/IR, etc.)Direct ConnectionsDirect Connections
MESERPPLM DMS
LES
SDMSLIMS
•All data is stored securely in a database
•Checksums to ensure signed data is unaltered
• Information directly from data systems
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• Concurrent user licensing eliminates any business benefit of shared user entities
• User Security manages Roles, Groups and Users to ensure appropriate privileges and security are maintained for each user
• Ensure that the data managed by CROs and other agencies is also appropriately managed
Data Integrity Issue: Shared User Identities
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Data Integrity Issue: Lack of Training in Data Integrity
Training Records can be managed within SampleManager LIMS ensuring that all training is up to date
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Thank you and any questions?