We realize how important it is to have access to have the proper training and resources when a project is facing regulatory agency inspection. So we created Validation Center™, an online resource for answering CSV and SQA questions and providing support to your team.

At Validationcenter.com we share our extensive library of documentation such as warning letters, FDA guidelines and CSV templates that your team can use. We also offer online training in the form of webinars and on-site training.

 

Part 11 Audit Readiness Consultants

Our CSV Experts

Our team is led by CSV Expert Deb Bartel, and CSV Expert Rodrigo Perez. They bring over 50 combined years of Computer System Validation experience in the regulated life sciences industry.

Meet Deb Meet Rodrigo

Our Approach to Software Validation Consulting

  • 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 feel that your approach to software validation could be more efficient, let us identify process improvement areas and incorporate risk-based practices into your methodology.
  • And, when you just need a little advice, use our CSV and SQA expertise on a retainer basis, so you only pay for the guidance you need.

Our Approach to Compliance Audits

  • If you have an important upcoming customer or regulatory agency inspection, our certified quality auditors can 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, we can perform the audit on your behalf.
  • Our consultants 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.

Our Approach to 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.
  • 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.

Validation Center™ Library

  • We have a full library of computer system validation templates and software quality assurance SOPs. These are the same templates that our experts use on projects and in training courses.
  • But the Validation Center™ Library is more than just templates. It also provides validation professionals with easy access to FDA Warning Letters, FDA and international regulations, domestic and international guidelines.
  • The Validation Center™ library evolves and changes over time. We add new information regularly, so subscribe to our mailing list to keep up with the latest compliance trends