Some of the most challenging areas to maintain compliance to FDA regulations include blood, blood derived products, and blood screening tests, tissue and bone based products, and biologics. QIS provides support to companies in achieving compliance with meeting regulations, quality standards, technical standards, and guidelines. QIS provides auditing services and technical writing services related to the manufacturing, testing, labeling and handling of these regulated products, as well as regulatory review submission support.
- Review quality procedures are followed
- Review test results/data to ensure test methods are followed
- Review/Audit practices within facility against procedures
- Assistance with Internal Audits
- Review production, labeling records
- Review/audit regulatory submission information