If you are seeking computer system validation experts, look no further. Xybion has demonstrated expertise validating computer programs for all types of regulated businesses in the energy, transportation, financial services, and life sciences (including FDA-regulated businesses such as pharmaceutical and medical device manufacturers, clinical research organizations, and GLP laboratories).
We offer a global experience to oversee GxP or other compliance standard needs from our headquarters in the United States or offshore in our Global Delivery Center in Chennai, India.
Xybion experts have a thorough understanding of federal regulations and industry-accepted software development standards. Our clientele is comprised of industries regulated by the FDA, FCC, IRS, and SEC. We utilize a five-step process for all computer system validation projects:
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.