In accordance with cGxP regulations, ISO standards and OSHA regulations, organizations must ensure that personnel performing various duties have the appropriate education, training, and experience to perform their duties. To document and demonstrate that these requirements are being met, organizations must also keep training records.
Xybion provides a comprehensive training and competency management software module as part of its CQRM XD Quality Management software suite. The cloud-based software helps you comply with requirements for electronic signature, electronic records, and software validation such as 21 CFR Part 11 from the FDA.
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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.