GAMP4-Compliant Software to Automate Cancer and TPN Drug Manufacturing
Challenge
A large multinational pharmaceutical company that develops and supplies lifesaving oncology and critical-care medications needed to replace an outdated, non-scalable system for ordering and manufacturing short-living chemotherapy and total parenteral nutrition (TPN) drugs. The previous system was unreliable and costly to maintain: it split the dispensing-pharmacy and TPN functions into two separate modules that had to be supported and updated manually, could not scale to support the company's growth, still relied on dated ordering media such as fax and phone, and did not comply with the latest GAMP4 standards. The company needed the system rebuilt as a scalable, easily updatable, full-cycle platform running both at its own sites and at its medical customers' facilities, adding the missing ordering, invoicing and reporting capabilities while safeguarding the manufacture of first-line oncology drugs and TPN medications.
A large multinational pharmaceutical company that develops and supplies lifesaving oncology and critical-care medications needed to replace an outdated, non-scalable system for ordering and manufacturing short-living chemotherapy and total parenteral nutrition (TPN) drugs. The previous system was unreliable and costly to maintain: it split the dispensing-pharmacy and TPN functions into two separate modules that had to be supported and updated manually, could not scale to support the company's growth, still relied on dated ordering media such as fax and phone, and did not comply with the latest GAMP4 standards. The company needed the system rebuilt as a scalable, easily updatable, full-cycle platform running both at its own sites and at its medical customers' facilities, adding the missing ordering, invoicing and reporting capabilities while safeguarding the manufacture of first-line oncology drugs and TPN medications.
Solution
INNERLUXES implemented the new integrated system on the .NET platform, with server and client applications interacting through .NET web services. The solution is organized into six modules. Data maintenance stores the system's objects such as hospitals, patients, orders, batches and statuses. Production covers the full manufacturing process from order and recipe entry through pre-compounding, compounding, post-compounding, labeling, release and delivery. Stock control monitors component inventory and restocking to keep production uninterrupted. Invoicing tracks the full procurement process with quick filtering for outstanding, overdue and paid invoices. Reporting generates KPI, order, stock and expenditure reports with charts and trend overviews. Security safeguards every important step, requiring a user PIN beyond login. With the software installed at a hospital's dispensing unit, a physician can enter an order and route it to the nearest factory, whose software validates the recipe, dose and components and can plan production for an entire course of treatment. The system was built to ISO-9001 and GAMP4 standards.
INNERLUXES implemented the new integrated system on the .NET platform, with server and client applications interacting through .NET web services. The solution is organized into six modules. Data maintenance stores the system's objects such as hospitals, patients, orders, batches and statuses. Production covers the full manufacturing process from order and recipe entry through pre-compounding, compounding, post-compounding, labeling, release and delivery. Stock control monitors component inventory and restocking to keep production uninterrupted. Invoicing tracks the full procurement process with quick filtering for outstanding, overdue and paid invoices. Reporting generates KPI, order, stock and expenditure reports with charts and trend overviews. Security safeguards every important step, requiring a user PIN beyond login. With the software installed at a hospital's dispensing unit, a physician can enter an order and route it to the nearest factory, whose software validates the recipe, dose and components and can plan production for an entire course of treatment. The system was built to ISO-9001 and GAMP4 standards.
Results
INNERLUXES delivered a GAMP4-compliant, full-cycle solution that automates the ordering and manufacturing of generic and non-generic short-living chemotherapy and TPN drugs in support of better chronic disease management. A single GAMP4-compliant platform replaced the outdated, non-scalable two-module system, bringing together data maintenance, production, stock control, invoicing, reporting and security. Its client-server architecture lets hospitals and other clinical clients request medicines from the factory closest to them through the client application, with each medicine labeled with the patient's name, location, shelf-life date and storage requirements before delivery. The company and its end clients have relied on the delivered system in production for more than ten years.
INNERLUXES delivered a GAMP4-compliant, full-cycle solution that automates the ordering and manufacturing of generic and non-generic short-living chemotherapy and TPN drugs in support of better chronic disease management. A single GAMP4-compliant platform replaced the outdated, non-scalable two-module system, bringing together data maintenance, production, stock control, invoicing, reporting and security. Its client-server architecture lets hospitals and other clinical clients request medicines from the factory closest to them through the client application, with each medicine labeled with the patient's name, location, shelf-life date and storage requirements before delivery. The company and its end clients have relied on the delivered system in production for more than ten years.