Rapid QC Lab Qualification for Gene Therapy Company
Rapid QC Lab Qualification for Gene Therapy Company A newly-acquired gene therapy company needed to quickly release a therapy for a rare disease, requiring the qualification of a QC lab within a tight 8-month timeframe. Challenge: The primary challenge was time: 22 instruments needed to be qualified and ready for use within 6 months. Leveraging […]
Ensuring Regulatory Compliance for a Custom EDC Application
Ensuring Regulatory Compliance for a Custom EDC Application Our client, an ophthalmologic biotech company, required a custom Electronic Data Capture (EDC) application built by a third-party provider. However, the provider lacked knowledge of the regulatory requirements, presenting a challenge for our team. We were tasked with educating the provider, ensuring 21 CFR Part 11 compliance, […]
Streamlining Global LIMS Reporting for a Large Pharmaceutical Company
Streamlining Global LIMS Reporting for a Large Pharmaceutical Company Over the years, the client’s decentralized governance led to the creation of numerous redundant and site-specific custom reports in their legacy LIMS system. The challenge was to identify redundancies, consolidate report specifications, and implement new reports while ensuring that they met the requirements of stakeholders across […]
Reviving a Dormant Stability LIMS System for Efficient Workflows
Reviving a Dormant Stability LIMS System for Efficient Workflows Our client had implemented a Stability LIMS solution several years ago but never configured or validated it for their intended purposes. They continued using manual, paper-based workflows for managing stability studies. We stepped in to understand the system, gather requirements, configure, validate, and provide training and […]
Streamlined LIMS Implementation for a Growing Biotech Company
Streamlined LIMS Implementation for a Growing Biotech Company Our client, a growing biotech company, required a new LIMS system but was unsure which one to choose. We provided end-to-end support, starting from vendor selection to full implementation, including project management, configuration, validation, training, SOPs creation, and ongoing support. Challenge: The client needed a LIMS solution […]
