Business Process Management

PRODUCTS

  • Our team of experts are equipped to guide you through every step of any Inspection, especially Pre-Approval Inspections, due to the nature of their criticality.

  • Selecting a manufacturing partner who can manage all aspects of your product development lifecycle and associated supply chain is essential to improve efficiency and product quality.

  • PHCbi brand’s LabSVIFT® IoT lab management solution is designed to provide real-time visibility and control of laboratory equipment and environments across single or multiple facilities. This cloud-based platform enables centralized monitoring, customizable alerts, and secure data access via a web-based dashboard. The new health check* function continuously evaluates equipment performance, identifies irregularities, and provides recommended corrective actions to maintain optimal operation. The system supports FDA 21 CFR Part 11 compliance and is compatible with select PHCbi and third-party devices. *health check function compatibility varies by model

  • Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?

    Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.

  • Co-invented by Applied StemCell’s President and Chief Scientific Officer, Ruby Tsai, Ph.D., and Head of R&D, Alfonso Farruggio, Ph.D., TARGATT™ large knock-in technology enables rapid, efficient, and precise integration of large DNA fragments—up to 20 kb in a single reaction, more in nested reactions—into a specific intergenic locus.

WHITE PAPERS AND CASE STUDIES

NEWS