All modern instrumentation is operated through computerized software whose criticality cannot be overstated given its role in instrument control as well as data acquisition, processing and reporting.  Despite their importance, these systems are often overlooked by laboratory compliance programs and can result in FDA 483 findings.  But important doesn’t mean compliance should be expensive. 

Workstation software validation ensures that OEM software is up to the task of complying with FDA requirements such as 21 CFR Part 11.  CSA offers a focused service designed specifically for this type of off-the-shelf software.  Our approach simplifies the scope of testing while ensuring critical requirements are defined and met, such as:

  • Instrument importance as it pertains to drug safety
  • Touch-points to LIMS, CDS or data storage systems
  • Data security requirements
  • System functionality boundaries
  • Procedural controls for operation and administration
  • IT infrastructure policies


Data management is just as critical to the laboratory as the instruments themselves. LIMS, CDS, calibration management and other enterprise software systems significantly improve laboratory performance by automating a wide variety of processes and data transactions.  But their real value lies in their endless configurability which is used to suit the specific needs of any operation.  However, the challenge for the GMP laboratory is validating what is essentially a unique system to meet FDA and international regulatory requirements.

CSA offers the perfect framework to ensure these validation projects are a success.  Our experienced consultants employ a unique validation model designed specifically for enterprise software systems that works collaboratively with your team.  This methodology maps the software processes and develops targeted requirements for security, data integrity, electronic signatures and networking that address GMP and 21 CFR Part 11 demands.  We then use a proven risk management process to focus the scope of validation so that testing is focused on the software functions most critical to your business.  Not only does this result in a high level of FDA compliance (in fact, the FDA prefers risk based methods of validation) but it can also provide fresh insight into your laboratory operation.


Questions? Get in touch with us today to learn how we can help!

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