We deliver a custom approach to Software Quality Assurance (SQA), Computer System Validation (CSV) consulting and auditing to target the areas where you need assistance.

Expert Software Validation Consulting and Compliance Audit Services

  • If you’re new to computer system validation, we can help you get your SQA policies, procedures, and validation templates in place fast.
  • If you have an important upcoming customer or regulatory agency inspection, let us perform an Audit Readiness Assessment to show you where you’re compliant – and where you’re not. We will also deliver a prioritized action plan, so you can be ready on time.
  • When you don’t have the time or experience to audit your software vendors, our expert consultants can step in to perform the audit on your behalf.
  • We can also assess your company’s systems for compliance with 21 CFR Part 11 or Annex 11, identify any gaps, and work with you to develop a remediation plan.
  • If you feel that your approach to software validation could be more efficient, we can help you identify process improvements and incorporate risk-based practices into your methodology.
  • And, if you just need a little advice, we can provide CSV and SQA expertise on a retainer basis, so you only pay for the guidance you need.

Computer System Validation Training

Our computer system validation and software quality consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations.

Friendly Discussion ConsultantsIn addition to our consulting and compliance audit services, we have developed educational courses and webinars that help you apply the FDA, ICH, and Eudralex risk-based validation concepts to your projects to maximize the impact of your compliance and quality efforts. Our courses also incorporate industry standards and best practices, such as those found in PIC/S and GAMP.

Computer System Validation Courses (Live, Instructor-Led)

  • Computer System Validation Boot Camp®
  • Computer System Validation for Cloud and COTS Applications
  • (ONLINE) Introduction to Computer System Validation

FREE Computer System Validation Webinars (Online, 60-90 minutes each)

  • Computer System Validation Basics
  • Auditing Software Vendors
  • Preparing for a Software Quality Audit
  • Risk Based Approach to Software Quality Validation
  • Software Quality Regulatory Trends
  • Spreadsheet Validation
  • Fundamentals of 21 CFR Part 11
  • Annex 11 Introduction
  • Cloud and SaaS and GxP

If you are interested in learning more about our Software Validation Services and Training offerings, visit Validation Center.