Case study

Complex Systems for Biologics Laboratory

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Risk Assessments

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Procedural Solutions

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Computer Validation

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System Investigation

Investigation & Implementation of Various Complex Systems for a Biologics Laboratory

biological lab test tubes


Some of the challenges that arose from this project:

Malvern NTA application Nanoparticle Tracking Analysis

Challenge #1: Malvern Nanosight NS 300 Particle Size Analyzer System failed to run a successful test.  The software was not opening the video for processing and not writing raw data files.

ANSA solution: An investigation was performed, and it showed that when the Delete permission was enabled for Authenticated Users the run is performed successfully.

Challenge #2: The solution for challenge #1 created a data integrity issue during this validation.  In enabling the Delete permission, the Authenticated Users can delete data from the application by using the delete key on a keyboard.   

ANSA solution: Global domain policies were applied to the Malvern PC to secure the data on the system.  The drive that contains the original data will be hidden from standard users. A shared folder will be accessible to standard users with a (read only) function to access reports and view results.

Limitations of the system:

  • The application is not capable of following password complexity per company IT policy.
  • Application does not enforce user to use a combination (at least 3) of lower case, upper case, numbers, and symbols.
  • The application fails to remember password history to a minimum of 24 changes.
  • The application fails to time out after 20 mins of user inactivity.
  • The application fails to provide an audit trail of failed login attempts.
  • The application fails to provide Audit Trail searchability.
  • The application fails to paginate the reports generated.

ANSA solution: We performed a Risk Assessment and provided procedural solutions for each limitation.  The application would be on a computer workstation that required users to login using their company domain login that satisfied the requirement for password complexity, password history, time out inactivity, and audit trail of failed login.  Per procedure it was a requirement to paginate printed reports.

Illumina MiSeq System

Challenge: The Illumina MiSeq Control software and local run manager were miscommunicating and displaying different run statuses, the Illumina MiSeq Control Software application became unresponsive and failed to complete a run. 

ANSA Solution: An investigation was performed; discussions were escalated to the vendor and several possible root causes were proposed.  Some of the possible root causes had to do with the computer’s configuration, insufficient RAM Usage, CPU processors or Ant-virus applications. It was decided a new configuration using a stand-alone bridge computer to collect the Raw Data and Meta Data would be implemented. 

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