Single Use Support Qualification Validation FAQ
Single Use Support Qualification Validation FAQ
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Qualification & Validation FAQ
- Does Single Use Support have a quality system and standard qualification procedures?
- Are Single Use Support’s computerized filling and freezing/thawing systems compliant with the 21 CFR Part 11 requirements?
- Which principles will be applied when developing and validating the systems?
- Is it possible to do only part of the qualification? Or is it possible to hand over the entire qualification process to Single Use Support?
- What does the standard qualification process of Single Use Support look like? (high-level description)
- What is the difference between FAT/SAT and ICQ?
- How is the testing strategy developed?
- Who can help us draft a URS in case we are interested in a computer-based system?
- Do you also assist with maintenance and troubleshooting?