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Qualification
Fast Trak™ services support all custom-made solutions with accurate IQ/OQ documentation.
Validation
Fast Trak BioPharma Services provides developers of biotech products with practical support and advice on particular biopharmaceuticals. We can help you plan, implement and document downstream purification processes, from start up to routine production, as well as train your personnel.
Validation documentation
We provide extensive documentation to comply with FDA and other regulations. During the past 10 years, we have delivered more than 2000 IQ/OQ documents worldwide.
- System and column installation and operational qualification packages (IQ/OQs)
- Change control protocols (CCPs) for software updates and other modifications
- Standard operating procedures (SOPs) for UNICORN™ controlled systems and process columns
Performance of IQ/OQ and CCP
In addition to IQ/OQ and CCP documentation packages, we have service engineers who can execute IQ/OQ and CCP testing for your company. This saves valuable time and prepares you for process validation. Our engineers are specially trained and certified to perform these procedures. On completion of testing, all requisite documentation is completed and handed over.
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