GAMP4-Compliant Software to Automate Cancer & TPN Drugs Manufacturing
The Customer is a multinational pharmaceutical company with operations in over 100 countries, 80+ years of experience and $15+ bln revenue. It provides caregivers and patients with lifesaving oncology, renal and transfusion medical products. With extensive experience in drug research and development, the Customer supports care providers in their mission to deliver quality care across hospitals, clinics, assisted living facilities and patients’ homes.
The Customer needed a centralized solution to cover generic and non-generic short-living chemotherapy drugs and TPN production (such as cyclophosphamide, 5-FU, cisplatin and more), stock control, client information and financial transactions (direct sales). This solution was to be used not only at the organization, but also at its medical customers’ facilities.
The previous Customer’s system was outdated, unreliable and costly to maintain. It included two separate ‘dispensing pharmacy’ and ‘total parenteral nutrition’ modules, which were to be supported and updated manually. Besides, this system was non-scalable, which impeded the Customer’s further business growth. The ordering process was carried out via such outdated media as fax and phone. Moreover, the solution was not in compliance with the newest GAMP4 standards and requirements.
Therefore, the Customer requested to rebuild the system to make it scalable and easily updateable. The new solution was to align separate modules, create the then missing ordering, invoicing and reporting functionality to deliver the full-cycle system capable of safeguarding manufacture of first-line oncology drugs and TPN medications.
The Customer chose a .NET platform for implementation of the new integrated system. The server application and clients interact via .NET web-services. The solution consists of the following modules:
This module contains a database storing the system objects such as hospitals, patients, orders, batches, order status and more.
The production module covers the full process of medicine manufacturing: drug order and recipe entry, entry review, pre-compounding, compounding, post-compounding, labeling, release and delivery. Let’s review how this module works.
For example, the new system is installed at a hospital’s dispensing unit. This hospital’s physician prescribes an oncology drug for a particular patient. Then this physician or a pharmacist uses the system to enter the order and send it to the factory closest to their location.
The factory receives the order, and the software automatically performs the validity check to make sure the recipe is adequate, the dose is right and components are relevant. The system can also plan the medication production for the whole course of treatment after one order. It calculates the quantity of doses for, say, a 6-week course and schedules specific dates for each dose preparation and delivery.
On the pre-compounding stage, the system automatically selects right components for the medicine mixture according to the ‘least waste' policy. The solution also supports printing out of instructions on required components and mixing techniques. Then a dispensing isolator technician uses this instruction for medicine preparation. The post-compounding stage includes another validity check to ensure a high quality of a freshly created drug.
During the labeling, release and delivery stage, the medicine gets a sticker with the patient’s name, his or her location, shelf-life date and storage requirements. Then this drug is handed to a courier and delivered to a patient.
With this module, the Customer’s specialists can oversee the flow of products, monitor the inventory of components and timely restock them. It allows the Customer to support uninterrupted production of new medicines and deliver them to patients timely.
The invoicing module allows the Customer to track the complete medication procurement process. The company can create new invoices, and search them by Client, Project, Invoice Status or Date of Creation. The quick filtering option also allows to check outstanding, overdue and paid invoices in one click.
To keep a detailed history of all transactions, the organization can generate various reports based on KPI, orders, hospital clients, stock, expenditure and other factors of the user’s choice. Charts, metrics, trend overviews and periscope reports enable in-depth population health data analytics of current operational and financial processes, as well as foreseeing areas for improvement.
The security module makes sure every important step is safeguarded and authorized. Apart from login-password authorization, each medicine manufacturing step requires entering a user’s PIN.
ScienceSoft delivered a GAMP4-compliant full-cycle solution to automate generic and non-generic short-living chemotherapy drugs and TPN order and manufacturing for better chronic disease management. The solution includes data maintenance, production, stock control, invoicing, reporting and security module. The client-server architecture was applied to allow hospitals and other clinical clients to request medicines from the factory closest to their location using the client application.
The Customer and its clients have been using the delivered system for 10+ years so far.
Technologies and Tools
Development processes: ISO-9001, GAMP4