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Software Validation for Analytical Instrumentation

Software used for analytical work can be categorized into three distinct groups in accordance with the USP 31, Section <1058>: firmware, instrument control, data acquisition, and processing software, and stand-alone software.

Analytical Instrumentation Firmware

In the realm of computerized analytical instruments, integrated chips with low-level software, commonly known as firmware, play a pivotal role. These instruments heavily rely on properly functioning firmware for their operation, and users typically lack the ability to modify firmware design or functionality. As a result, firmware is considered an integral component of the instrument itself. Qualifying the hardware, in this case, the analytical instrument, would be incomplete without ensuring the integrated firmware's proper operation. Hence, when the hardware is qualified at the user's site, the integrated firmware is inherently validated. There is no need for a separate on-site qualification of the firmware. It is advisable, whenever possible, to record the firmware version as part of the Installation Qualification (IQ) activities. Any changes made to firmware versions should be meticulously tracked through the instrument's change control process.

Instrument Control, Data Acquisition, and Processing Software

In many modern computerized instruments, the software responsible for instrument control, data acquisition, and data processing is installed on a computer that interfaces with the instrument. This software assumes a critical role in controlling the instrument's operation and is essential for tasks such as data acquisition and post-acquisition calculations. In this context, both hardware and software are interdependent in delivering accurate analytical results.

The manufacturer holds the responsibility of validating this software functionality. Subsequently, the manufacturer provides users with a summary of the software's validation. When it comes to the user's site, a holistic qualification approach, encompassing the entire instrument and software system, proves more efficient than modular validation of the software in isolation. Therefore, the user qualifies the instrument control, data acquisition, and processing software as part of the Analytical Instrument Qualification (AIQ) process.

Stand-Alone Software

Validating stand-alone software, such as Laboratory Information Management Systems (LIMS), follows a well-established guide. The software developer takes charge of the validation process and specifies the appropriate development model for the software. Validation entails a series of activities meticulously planned and executed throughout various stages of the development cycle, including:

  • Configuration of security and access control for the user community.
  • Customization of the software to align with your laboratory's specific workflow.
  • Definition and testing of 21 CFR Part 11 functions as used in your laboratory.
  • Implementation of custom reports.
  • Implementation of custom calculations.
  • Development of macros defined and written by the users.

These steps ensure that the stand-alone software operates in accordance with established quality and compliance standards, meeting the specific needs of the laboratory's operations.