Platform for Monitoring Drug Stability Budget on Excursion

Business Overview

The client is a well-known US pharmaceutical company providing B2B tech solutions to drug manufacturers and distributors, enhancing their workflow efficiency, optimizing costs, and improving public health in general.

The client wanted to build a platform for tracking and previously manual assessing of drug stability budgets—the time a product can be held outside its labeled storage conditions without risk to its safety and efficacy. The process was prone to error and could take anywhere from days to months. Such a scenario led to drug wastage and money drain for companies and posed a risk for patients not to get the required medication in time. With no analogs on the market, the software intends to evaluate storage and transportation conditions regarding stability data and alerts about possible excursions. The platform is intended to accelerate decision-making on the release of drugs for consumption and provide prompt response to impending excursions.

The company reached out to NIX as we’ve already accomplished several successful joint projects, demonstrating deep tech expertise.

Solution

As the product had no analogs, the client wanted to validate the project’s feasibility and viability, thus, we started developing a Proof of Concept (PoC). NIX experts assessed the market demand and found the best ways to execute a full-scale development process for maximizing the client’s ROI.

Core Features of the Platform

Among the platform’s extensive set of features, the following stand out:

Tracking and monitoring of drug storage conditions along the entire journey for automated assessment of drug status and alerting for deviations, if any
Gathering real-time data via integration with the customer’s ERP system and temperature sensors
Automatic recalculation of excursion terms when the manufacturer’s stability budget requirements have changed, even if the drug is currently on route
Audit trail for secure and time-sequenced recording of data modifications, including manual edits, to evidence actions performed
Compliance with 21 CFR Part 11 regulation considering electronic records and signatures as trustworthy and reliable

Software Development Flow

Software Development Flow

Our experts developed a microservice architecture, providing data exporting through a data lake, record cleansing, structuring through a data pipeline via AWS Glue, and data storage with the help of PostgreSQL. We also developed a separate module for stability budget calculations.

To make the system high-performing and easily scalable, NIX experts used AWS and integrated the platform with the customer ERP system, SAP, and internal temperature sensor modules.

Developing extensive and well-grounded business logic, we provided seamless communication of all subsystems and unhindered data processing, considering scenario changes, industry regulations, stability form documents and calculations, and real-time temperature indices during delivery.

How the System Operates

The platform collects real-time data from temperature sensors placed in the delivery cargo. It then connects established stability budgets and data from the customer’s ERP system with delivery conditions, subtracting time out of the refrigerator during manufacturing, packaging, and distribution stages. After calculations, the system notifies managers in case of excursion events. Next, the quality assurance manager from the customer’s side decides whether a particular product is considered safe for further usage or not.

Outcome

Outcome

The client received a unique web platform for monitoring the stability budgets of drugs and automated excursion assessment calculated almost instantly—this helps companies reduce drug wastage and save resources. The platform brings the following benefits to drug manufacturers and distributors:

Reduced costs on drug budget assessment due to automated workflows
Significant time savings for data processing—minutes instead of weeks
Lowered product wastage by timely determination of the end of product expiration dates
Reduced manual work resulting in error reduction and mitigated risks
Ability to improve transport and storage conditions for longer shelf life of drugs
Decreased risks to drug safety, quality, and efficacy due to monitoring
Reducing delays in delivery, maximizing patients’ chances of receiving their medicine on time

NIX continues collaboration with the client to enhance the existing software functionality, planning to soon add advanced analytics, extend data retention time, and make the system multilingual.