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

Using LIMS to Drive Data Integrity in a Regulated Environment Dr David Hardy Technical Solutions Manager Digital Sciences The world leader in serving science

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 2

Why is Data Integrity Important? Consider the Consequences د . إ £$ ر . س € 3

Data Integrity is a Major Regulatory Issue Global issue but what are the causes? 4

Data Integrity is a Major Regulatory Issue Good Intentions – Soon Overwhelmed 5

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. 6

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 7

Regulated Environments 8

Data Integrity - What’s the Solution? The world leader in serving science

Informatics Aids Data Integrity Compliance Laboratory Data Visualization Lab Management Execution Methods & Raw Data LIMS SOPs Procedural Execution Complete Laboratory Visualize without original Management Drives users through a process application in a stepwise fashion Sample, test, & result Laboratory data archival, management Configuration, not customization retrieval and preservation to deploy methods and SOPs Management of lab personnel Support for >180 instrument & resources Connects to the general LIMS data formats capabilities to provide an Process optimization & Vendor independent XML for integrated solution standardization long term storage Thermo Fisher Scientific SampleManager LIMS provides a complete picture of your laboratory data from the original raw data to final results 10

Data Integrity Issue: Adhere to Your SOP Maps your SOP’s (methods) electronically to aid execution and compliance 11

Data Integrity Issue: Adhere to Your SOP Lab Execution details can be added Background information and prerequisites are shown before starting the execution 12

Instrument Selection Instructions per step Different prompts per step Step wise approach 13

Drift Check Result Entry Result Entry, manual or from an Hazard signs shown instrument during execution Limit checks done during execution, includes MLP checking 14

Calculations and Final Result Calculations done (using values from previous steps) eSignature configuration per step 15

Review Execution Review by exception Accept or Reject steps or overall execution 16

Data Integrity Issue: Unofficial Testing SampleManager LIMS manages the complete laboratory workflow ensuring testing procedures are followed correctly Graphically define your lab process in the system Automate your laboratory decisions and improve your ability to respond to the needs of your business 17

Data Integrity Issue: Lack of Complete, Lost or Deleted Data SampleManager SDMS provides secure, future-proofed data archival & management . . 18

Data Integrity Issue: Lack of Complete, Lost or Deleted Data - SDMS Solution 19

Data Integrity Issue: Failure to Sign/Approve Tests or Reports LIMS manages the complete review and approval process to ensure correct sign off has occurred View Procedures Scan Operator Approval Control Sample ERP Instrument Calibration Control ERP Stock Not Expired & Usage Lot Disposition Control Batch Records Update Sample Test Sample Result Test Batch/Sample Result Login Assignment Receipt Entry Approval Approval Approval (Manager) (QA) (Supervisor) Labels Instrument e CoA View Data Instrument Data Capture OOS 20

Data Integrity Issue: Access to Data via the Operating System PLM DMS ERP MES • All data is stored securely in a database • Checksums to ensure signed SDMS data is unaltered LIMS • Information directly from data LES systems Direct Connections Direct Connections Data Systems (CDS, MS, FT/IR, etc.) Data Systems (CDS, MS, FT/IR, etc.) 21

Data Integrity Issue: Shared User Identities • 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 22

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 23

Thank you and any questions? 24