Solution for the pharmaceutical industry

Monitoring drug production for one of the largest pharmaceutical companies of Europe. We used .NET, E/F, HTML5, JayData and a complex OLAP reporting system.

It is all about internal and external regulations, audits and recording every major action while employees want flexible, hassle-free, easy-to-use, paperless systems. JayStack is the company to help you there. With nearly four years of experience in deploying solution for the pharmaceutical industry, we have created LIMS systems that monitor sterile environments and personnel across all stages of product development.
Our technology powers the rather complicated process of creating or changing the packaging of a pharmaceutical product. We created systems that makes it easy to check if managers have the right to sign this or that procurement request. Job descriptions can be recorded, queried and updated thanks to our software – a task that might sound easy, but is as complicated as important for something as regulated as the pharma industry.
Our main pharma customer, Richter, trusted us with more than four different systems, all created on time, on budget, and meeting the specications, while also keeping agility and enabling changes during the development cycle.

Environmental monitoring software - LIMS

Timeline

  • Go-live in 11 months from kickoff
  • 9 month of agile development
  • 2 month of validation and documentation

Business value

  • Planning and scheduling of monitoring of cleanrooms according to SOPs
  • Digital limit definitions for different purity levels (“A”, ”B”, ”C”, ”D” rooms)
  • Managing surface, passive air and active air samples
  • Barcode scanning with offline-capable tablet application or desktop PCs
  • Processing metadata of Merck rodac barcodes
  • Creating packages and dispatching to labs
  • Tracking samples and packages through all phases of delivery
  • Support for interim incubation
  • Assessment of samples
  • Alert/Action limit verication
  • Automated deviation reports

Project outcome

  • 21 month since go-live
  • Prize winner of Richter Technology Innovation Foundation 2015
  • 2 FDA inspections

JayStack expertise

  • Envisioning of paperless, automated quality control processes for regulated monitoring
  • Designing GAMP-conform software for cleanrooms, labs and offices
  • Developing online/offline field data capturing mobile application
  • Labeling: barcode printing and scanning
  • Agile project management to deliver the maximal business value
  • Building data warehouse and reports

Packaging Change Manager

JayStack expertise

  • Digital workflows for changing product packaging
  • Analysing user requirements and business needs and driving project scope to cost-efficient project goal
  • System integration with heterogeneous external systems
  • Automating processes to minimize data entry and human interaction
  • Comprehensive data integration with external systems (such as SAP modules)

Business value

  • Efficient communication and teamwork across multiple divisions
  • Collaboration on product sheets and documents using standardized workflows
  • Life-cycle management of product packaging materials
  • Aggregated overview of purchase orders and demands for material change
  • Optimized task management via batch operations
  • Congurable workows driven by user-defined templates

Change Control System

JayStack expertise

  • Digital workflows for managing of regulated changes
  • Agile project management to deliver the maximal business value
  • Automating application tests
  • Building executive and KPI reports
  • Configurable workflows and forms for different change types

Business value

  • Collecting feedback, decision and approval based on competence and responsibility
  • Automated generation of activities based on change type configuration
  • Multi-level approval based on configuration