Ajairu Computer System Validation (CSV) Consulting Services
Who We Are
Headquartered in the greater Baltimore-Washington area, Ajairu CSV Consulting supports GxP companies and companies seeking to become GxP compliant. Ajairu’s Executive Director, Yoshimi Yancey, offers over 30 years of total IT experience specializing in GxP to include Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Documentation Practices (GDP).
Ms. Yancey has over 20 years extensive and progressive knowledge and experience in the field of software validation and compliance with particular expertise in Computer System Validation (CSV), Software Quality Assurance (SQA), SAP/ERP CSV, FDA/EMA/MHRA/EU GxP Compliance, 21 CFR Part 11, 21 CFR Part 280, Risk-Based Validation, IT Risk Management, SDLC, GAMP, and Waterfall and Agile Methodologies. Having begun her life science career as a molecular biologist and serologist, Ms. Yancey is able to draw upon her expertise in clinical research and laboratory practices to inform her actions and decisions related to computer system validation efforts.
“Ajairu” means “agile” in Japanese. As the name of our company implies, we provide a streamlined and efficient CSV methodology. We are able to help GxP companies cut their validation time and effort to a minimum. Projects that normally take a year to validate can be completed in a matter of months. For companies seeking GxP compliance, validation programs and quality management systems can be set up quickly and efficiently. Our streamlined processes, which have been developed and refined over many years, allow companies to save time, money, and resources as they prepare to be audited for compliance.
Please click the “Contact Us” link at the top of the page to let us know how we can help with your validation project or regulatory audit.
Contact Us
Ajairu CSV Consulting
ajairucsvconsulting@gmail.com
(301) 651-9726
What We Do
Advising
Ajairu advises current GxP customers with existing CSV programs in how to greatly streamline and standardize their processes and templates. We also advise non-GxP companies in building robust CSV programs. We help both GxP and non-GxP companies to prepare for Regulatory inspections to include those conducted by the FDA and the EMA as well as client audits. We pride ourselves in helping customers achieve zero findings.
Training
We train in all aspects of the Computer System Validation process. We help employees understand all facets of Computer System Validation and why CSV is so important. We provide companies with proven procedures for developing and executing all validation deliverables to include Change Controls, Risk Assessments, Requirements, System Designs, IQOQPQs, Test Plans, Test Summaries, Validation Plans, and Validation Summaries. We give detailed instruction on how to use our streamlined and efficient SOPs and Templates, and unlike many other companies, we offer ongoing support to the customers we serve after trainings have ended.
CSV QA
Oversight
It is a regulatory requirement that GxP companies have an independent CSV QA entity to review the work produced in connection with computer system validation efforts. Failure to show separation of duties has caused many companies to receive major findings in audits that must be addressed by obtaining an independent QA entity. Yoshimi Yancey has over 20 years of experience as an independent CSV QA entity for GxP and non-GxP companies. Ms. Yancey and her staff at Ajairu will ensure your company will pass audits with no critical or major findings and keep your projects on track. Our ultimate goal is always zero findings - a goal we have accomplished time and time again!