Data Integrity & Compliance

Mukunth Venkatesan

Mukunth Venkatesan started his career as a bio-medical instrumentation engineer.
He joined Agaram group 26 years back to lead the analytical instrumentation and R&D division for manufacturing HPLCs in India. Mukunth moved on to establish a software development team for
instrumentation. Once he cut his teeth in instrument software development, the next logical step was to start developing “Laboratory Informatics” software. Agaram Technologies today is a well-established “Laboratory
Informatics” player having implemented its Qualis© LIMS, Logilab ELN©, Logilab SDMS© and Qualis© DMS suite of products at a host of Pharmaceutical and Life Sciences laboratories across the globe.

Risk & Mitigation at Data Generation & Recording stage

How and where is original data created and what to do with data?

  • Data is created by users and instruments in local/network drives
  • Automation should store a “True copy” in the server (controlled area)

How do you ensure that the data is complete, accurate and traceable to meet ALCOA?
Automation should ensure

  • A (who, which instrument, why, what purpose
  •  L (Electronic copy should be legible & longevity)
  •  C (contemporaneous as & when created/modified)
  •  O (original copy to be saved and verifiable)
  •  A (Automatic capture without human intervention)

Risk & Mitigation at Data Generation & Recording stage

Is it possible to recreate, amend or delete original data and metadata?

  • Automation should help in identifying amendments & version data automatically
  • “NO” possibility to delete or obscure data 8

How data is transferred to other locations or systems for processing or storage?

  • Automation should help in download/restore of data in a controlled manner for processing or storage
  • Any change due to processing to be handled by automation system with version control

Risk & Mitigation at Data Accessing & Processing stage

How is Meta data handled?

  • Method used for processing to be identified as metadata for capture
  • When no external metadata is available
  •  Raw data should contain relevant metadata
  • Else manually record metadata

How is impact of data processing handled?

  • Any change to data due to processing should always be
    captured by the automation system (version control)

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