Systems Validation

The Computer System Validation (CSV) Department is responsible for providing guidance in the validation of computerized systems used in clinical research.  This effort is to comply with the Food and Drug Administration (FDA) and Institutional Standards that require data to meet specific fundamental elements of quality.  These fundamental elements require source records that are created, maintained, or transmitted electronically to be attributable, legible, contemporaneous, original, and accurate (ALCOA),and that required documentation will serve as evidence of compliance.  To assist in satisfying these requirements, the CSV team offers the following:

  • System validation lifecycle management and periodic review
  • Guidance in the development of procedural documentation (SOPs).
  • Guidance in formal testing practices
  • 21 CFR Part 11 training and awareness

For questions or to request a system assessment, please contact a CSV team member at ciso@miami.edu.

How Do I Know If My System Needs Validating?

FDA Regulations - 21 CFR Part 11 Compliance

If you are conducting research under an approved Investigational New Drug (IND) or Investigational Device Exemption (IDE), and computerized systems are used to collect and analyze research data, then the computerized system may be in scope for validation.  Whether vendor purchased, custom built or in the cloud, the system must demonstrate that it meets the requirements of 21 CFR Part 11.  Not complying with 21 CFR Part 11 may result in an FDA observation, warning or the disqualification of a clinical investigator’s research.

What is System Validation?

System validation is the process of testing and documenting that a computer system functions as intended for its use and in the context of the research conducted.  The process as a whole consists of the hardware, software, people and processes that interact; with an end goal of data quality, data protection and patient safety.  Required documentation in a validation must align with the industry standards and regulatory laws that guide the FDA in their evaluation and enforcement of compliance.  System validation benefits are:

  • Reduction in regulatory liability
  • Reduction in long-term costs in system implementation, management and use
  • A standardized and repeatable process towards quality in a system
  • Performance assurance to manage a given cGxP process.
  • Electronic evidence that sustains compliance based on proven functionality and user requirements
Procedural Controls

Documentation of procedural controls are required by the FDA and made available upon request.  They are generally in the form of standard operating procedures (SOPs) and user manuals.

Common documented procedures are:

  • User account management
  • Remote access for vendor accounts
  • Backup and Recovery
  • Good data management practices
  • Change control
  • Training (User and System)
  • Operational Use (as determined)

The content developed in your SOPs must address the system validation concepts which follow FDA regulations.


Are there training requirements for 21 CFR Part 11 compliance?

All Users (including system administrators and analysts) must have the education, training, and experience before being granted to access the computer system.  This includes training on relevant SOPs.  Completion of training must be documented and retained.


Where can I find more information on FDA Guidance?

Below are links to FDA guidance documents that may answer questions or concerns about implementing the regulation.