
Equipment validation
Ensure equipment is validated, tested, documented, and maintained to meet operational and regulatory requirements. Assuring consistent and efficient performance.
Solutions for Biotechnology
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Biotechnology processes often involve living organisms, introducing inherent variability. Validation professionals must develop strategies to control and minimize this fluctuation to ensure consistent product quality. Kneat enables best-practice controls for variability.
Complex molecules require sophisticated analytical techniques that produce more data, increasing testing burden. Kneat’s powerful, automated data management features de-risk, simplify, and streamline method validation.
Transitioning processes from laboratory scale to full-scale manufacturing without compromising product quality or efficacy requires thorough validation to address potential scale-up issues. Kneat enables efficient verification to enable the fastest possible testing during expansion.
The rapid rise of therapies like gene and cell therapies often outpaces regulation. Documentation must be flexible to navigate these uncharted areas to ensure compliance with evolving frameworks. Kneat provides the flexibility to easily update templates and workflows as needs change.
The flexibility of Kneat is huge ... if we want to onboard a new client, it’s a 15-minute meeting between us, and we set it up how we want. We update our process mapping document, and we move on.
- Laura Berberian, Manager, Quality Assurance Validation, ElevateBio
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