Laboratory Systems Auditing

In most regulated labs today, there are multiple computerized systems. There are off-the-shelf instrument systems like FTIR or UV-Vis spectrophotometers that require basic configuration for everyday use. There are configurable systems such as LIMS or CDS that require more complex configuration and interface with larger instruments and other applications within and across labs. And then there may be fully customized applications that are built for a unique purpose.

➜ Get started with an audit of your lab systems

Not only are there multiple systems being used, but also there may be multiple ways to access these systems. Analysts can walk up to stations within the lab, or log in from their desk, or even remotely from anywhere with an internet connection. With all the possibilities of systems, access, and data entry, one requirement remains in a regulated lab concerning computerized systems. These systems must all be validated for their intended use.

➜ Do you know what systems you are currently using in your lab, or if any need to be retired or replaced?
➜ Do you know if they are in a controlled, validated state that is fit for purpose?
➜ Do you know how much of your computing infrastructure and data are maintained in-house, or outsourced?
➜ Do you have policies and procedures in place that govern how computerized systems are validated?

CSols can conduct a lab systems audit to help you understand where your lab is in compliance with industry best practices for computer system validation, and where you may need to make improvements. (watch lab systems audit video)

A CSols audit will evaluate the
following items within your labs:

  • SOPs, policies, and guidelines
  • 21 CFR Part 11 compliance
  • CSV lifecycle documentation
    • Validation Plans and Reports
    • User and Functional Requirements and Specifications
    • Design and Configuration
    • Risk Assessments
  • Change control and periodic review processes
  • Disaster Recovery and Business Continuity
  • Backup, archive, and recovery procedures
  • Access and security
  • Cloud-based and hosted systems
Get started with an audit of your lab systems

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