Using LIMS to Drive Data Integrity in a Regulated Environment Dr - - PowerPoint PPT Presentation

The world leader in serving science

Using LIMS to Drive Data Integrity in a Regulated Environment

Dr David Hardy Technical Solutions Manager Digital 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

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Data Integrity is a Major Regulatory Issue Global issue but what are the causes?

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Data Integrity is a Major Regulatory Issue Good 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

• ver 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 Execution Drives 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

• r 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

Sample Login Test Assignment Result Entry Result Approval (Supervisor) Test Approval (Manager) Batch/Sample Approval (QA) Sample Receipt e CoA ERP Instrument Data Capture Labels Scan Sample View Procedures Operator Approval Control Instrument Calibration Control Stock Not Expired & Usage Control View Instrument Data OOS ERP Lot Disposition Batch Records Update

LIMS manages the complete review and approval process to ensure correct sign

• ff 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 Connections Direct Connections MES ERP PLM DMS

LES

SDMS

LIMS

• 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?