A large part of our success in the industry has been due to the development of our equipment and process control and monitoring software. Recognizing the rapid advancements in automation, Allpax pioneered the development of FDA compliant control and monitoring systems by working with USDA and FDA entities during its development. In over four decades of serving the industry, Allpax has continued to develop products that have helped our pharmaceutical customers stay one step ahead in regulatory compliance.
The Allpax software suite consists of our AllView human-machine interface (HMI), AllLog system function datalogging and Monitor reporting and process development software modules. All are FDA 21CFR Part 11 compliant. Our offerings, however, don’t stop there. Further enhancing our customers’ ability to stay in compliance, Allpax offers Bulletin 43L and 21 CFR 11 system validation software and services.
Allpax’s proprietary NFPA Bulletin 43L validation AllCheck includes a comprehensive test protocol for challenging our control system’s deviation detection, process control and alarming logic software, data logging and system reporting. All test results are recorded in the documentation package. The addition of our supplemental software package Challenger allows pharmaceutical manufacturers to perform periodical validations of their systems making the 43L validation a living document.
Allpax’s 21CFR11 validation focuses on the electronic record keeping functions within our control system. This validation includes a comprehensive test protocol for challenging the control system’s data capturing, storage and traceability as well as, user security and system reporting. As with the 43L validation, our Challenger software simplifies and automates the validation process.
Allpax controls and validation services are the vital finishing touches to our diverse industry leading in-container sterilization and material handling systems designed for the Food and Pharmaceutical industries. Our diverse line of industrial automated autoclaves is currently in use processing containerized medical components such as intraocular implants, IV fluids and blood plasma. Allpax automated material handling removes the hazards of human contact and manipulation of sensitive packaged medical items.