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)
Click here to download the document.
