FDA Form 483: When Inspections Reveal Issues
An FDA Form 483 outlines observations from an inspection that may indicate violations of the FD&C Act or related regulations.
KanBo supports pharmaceutical firms by offering Cards for each Form 483 item and tracking corrective and preventive actions (CAPA). Assign tasks, attach documents, and monitor resolution timelines with full traceability.
Turn Observations into Action Plans with KanBo
Turn Observations into Action Plans with KanBo
KanBo supports pharmaceutical firms by offering Cards for each Form 483 item and tracking corrective and preventive actions (CAPA). Assign tasks, attach documents, and monitor resolution timelines with full traceability.
KanBo Installation Options
The KanBo Platform boosts efficiency and optimizes work management. Whether you need remote, onsite, or hybrid work capabilities, KanBo offers flexible installation options that give you control over your work environment – all while meeting the highest security standards.
On-premise Installation
The best option for highly regulated organizations and public sector entities. KanBo’s on-premise installation allows organizations to maintain 100% control over their data and infrastructure. This is ideal for companies or IT teams that need absolute oversight, ensuring that sensitive information stays entirely within your managed environment.
Cloud Installation
The best option for fast and flexible deployment. Access KanBo software via a cloud provider managed by your IT team. This installation option enables easy scalability and the ability to access KanBo from anywhere, making it a great choice for organizations that prioritize agility and convenience while still maintaining robust security measures.
GCC High Cloud Installation
The best option for regulated industries. Access KanBo securely via Microsoft’s GCC High Cloud, designed specifically to meet compliance with federal standards like FedRAMP, ITAR, and DFARS. This installation is perfect for government contractors, defense, and other industries that require the highest levels of data protection and security.
Hybrid Installation
The best option for maximizing flexibility and security. Enjoy access to two KanBo instances – one self-hosted and one hosted on Microsoft’s infrastructure, including GCC High Cloud. This hybrid installation allows you to separate sensitive and non-sensitive data while ensuring scalability and robust security for each environment.
Roadmap for Implementation
Planning and Setup
Pilot Phase
Pilot Evaluation
Full Rollout
KanBo – Work Coordination Platform
KanBo is a work coordination software designed to help self-organizing teams work smarter and faster. You can see KanBo in action by accessing our demonstration environment.