Ultrasound Validation Project Summary

The Challenge:

A contract research organization (CRO) contracted Performance Validation (PV) to create a Computer System Validation (CSV) package for an ultrasound instrument.  They use the system during surgery to perform analysis flow, stress, wall thickness and detect blockage.  The instrument and its data acquisition/analysis software was purchased to replace an aging ultrasound system that was no longer being supported.  The previous system also saved data to an old tape recording system that would deteriorate and was becoming difficult to buy replacements for.  The lab conducts Good Laboratory Practices (GLP) compliant studies for their clients. To bring the system into GLP compliance, the system required validation. The high demand for surgical studies paired with a short workforce supply contributed to them contracting PV to validate the system in a timely manner to avoid down time.

The following computer system validation project considerations were identified for the client and their commercial-off-the-shelf (COTS) instrument/software:

  • Bringing the system into GLP compliance on an expedited timeline without significant in-house validation procedures or plans implemented
  • Evaluation of 21 CFR Part 11 compliance of the software or the laboratory procedures had not occurred
  • Qualification of the system’s configuration settings to ensure consistent and reproducible results
  • Ensuring the data appropriately stored to a validated cloud storage system for use in study reports
  • Minimizing impact on the stakeholder’s production responsibilities

The PV Advantage:

The PV team on this project had years of experience in GLP laboratory compliance including working on a comparable Ultrasound instrument which contributed to an expedient and comprehensive validation. PV immediately began work prior to being on site to expedite the project launch.  This was followed by onsite support and collaboration with laboratory stakeholders to complete the computer system validation.  The following components detail the PV solution:

  • PV team member was placed on an expedited training regime to become familiar with the system and the validation master plan in place at the facility.
  • Assistance reading/reviewing the SOP in place for the Ultrasound was provided and helped to determine the functionality being used by the client. This collaboration with the laboratory stakeholders helped ensure the timeline remained on track as well as satisfied the applicable regulations.
  • A User Requirements Specification was created by pulling information from the user manual for the software and hardware page-by-page. Then, the requirements were further developed and refined through partnering with the laboratory project stakeholders.  The team focused on the intended use and GLP applicability of the system.  This proved valuable as test script authoring commenced, the stakeholders could either assist in writing tests or delete requirements.
  • Creation of a 21 CFR Part 11 compliance assessment.  PV understood the regulations, the FDA Guidance, and the preamble requirements.  This assessment outlined areas of the software that needed to be addressed with a procedure (i.e. gaps) and was also used to create user requirements. A summary of how the gaps were addressed was also generated to include with the validation package.
  • A Validation Plan was created to outline the planned validation deliverables and the strategy for testing the system. It leveraged the favorable vendor audit and low risk score from ISPE’s GAMP 5 risk and complexity approach evaluation allowed the team to use a risk based approach to maximize efficiency and ensure compliance. This document
  • PV sent a team member to the clients’ site to work on documents and create test scripts. These test scripts were generated as early as possible to give the tester time to practice execution and allow for quality reviews prior to official execution.
  • The PV team member executed some testing and provided guidance and review for the remaining user acceptance scripts to ensure expedient execution.
  • A Requirements Traceability Matrix was created to document where each user requirement was satisfied with testing or vendor documentation.
  • Documentation was created using the clients’ approved forms and comparable formatting preference where applicable.
  • Concerning issues and documentation were shown to the Quality Assurance department to ensure they were appropriately addressed as early as possible to avoid further remediation.
  • PV provided regular project status updates which provided details on the project deliverables, project budget, and risks to the project and schedule.
  • A Validation Summary Report was generated explaining all the validation deliverables and how the clients’ documentation satisfied regulatory requirements.
  • PV provided the client with a “Lessons learned” document to help with future work there and provide insight they specifically asked for after completion of the validation.

The Results:

The lab instrument validation was completed ahead of schedule meeting the customer’s overall system implementation deadlines.  There were a list of observations issued and PV returned to the facility to address and expand testing ensuring all parties involved were satisfied. The validation effort brought the system into compliance with all applicable regulations through excellent documentation standards, testing processes, and a focus on the customer needs.  Business process and regulatory requirements were equally emphasized and constantly considered.

The Benefits:

Performance Validation provided the client computer system validation project execution and consultation through understanding the project, the stakeholders and their needs, and the best fitting validation strategy for a laboratory instrument.  The validation documentation focused on efficiency due to the time constraint and worked with the Information Technology, Quality Assurance, Subject Matter Expert, and Application owner to ensure responsibilities for each document were clearly outlined at every step in the project.  Performance Validation will continue to support the client beyond the system go-live in the event of auditing questions or change controls.

References:

CFR – Code of Federal Regulations Title 21: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

Guidance for the Industry Part 11, Electronic Records; Electronic Signatures – Scope and Application: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070295.pdf