Customer Company Size
Large Corporate
Region
- Europe
- America
Country
- Ireland
- United States
Product
- FlowForma Process Automation
Tech Stack
- Microsoft SharePoint
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Productivity Improvements
- Cost Savings
Technology Category
- Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
- Pharmaceuticals
Applicable Functions
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
- Process Control & Optimization
Services
- System Integration
- Training
About The Customer
The customer is a global pharmaceutical company. The company is highly distributed and fast-growing, with operations in multiple countries. The company had already implemented Microsoft SharePoint® to improve document processes. The company's IT Manager was tasked with finding ways of delivering better quality connectivity and applications to the business. The company's artwork management process was complex and heavily regulated, involving up to 10 people across multiple countries. The company was under pressure to meet different timescales in different countries for artwork approval by regulatory authorities. The company needed a solution that would provide control and visibility of the process, especially in light of increasing industry spot checks and rigorous inspections.
The Challenge
The client, a global pharmaceutical company, was facing significant challenges with their artwork management process. Artwork error was identified as the biggest reason for product recall in the pharmaceutical sector. Changes to artwork had to be approved by regulatory authorities within a finite amount of time, and the manufacturer was under pressure to meet different timescales in different countries. Prior to the implementation of FlowForma Process Automation, artwork was approved through numerous telephone calls and emails, typically involving up to 10 people across multiple countries. The process lacked clarity, timelines, alerts, and traceability, resulting in poor management and group oversight. With increasing industry spot checks and rigorous inspections, the client needed to gain control and visibility of the process.
The Solution
FlowForma Process Automation was introduced to streamline the artwork management process. The deployment took longer than planned as the company kept discovering more functionalities they could leverage. FlowForma Process Automation was used to provide two workflows. One to push through an artwork mock-up for preapproval by the regulatory authority, and the second for the actual production of the finished artwork with change requests. The design studio, based in Europe, creates the artwork and shares documents for approval with different parts of the world. The forms-based solution goes through an iterative process where people in other territories input their changes via automated workflow. The artwork coordinator uploads the final version and makes it available to each market where the product is scheduled to launch. Unlike other labeling solutions, FlowForma Process Automation continues right up to the point where a product is released to the manufacturing site at the end of the audit trail.
Operational Impact
Quantitative Benefit
Case Study missing?
Start adding your own!
Register with your work email and create a new case study profile for your business.
Related Case Studies.
Case Study
Case Study: Pfizer
Pfizer’s high-performance computing software and systems for worldwide research and development support large-scale data analysis, research projects, clinical analytics, and modeling. Pfizer’s computing services are used across the spectrum of research and development efforts, from the deep biological understanding of disease to the design of safe, efficacious therapeutic agents.
Case Study
Fusion Middleware Integration on Cloud for Pharma Major
Customer wanted a real-time, seamless, cloud based integration between the existing on premise and cloud based application using SOA technology on Oracle Fusion Middleware Platform, a Contingent Worker Solution to collect, track, manage and report information for on-boarding, maintenance and off-boarding of contingent workers using a streamlined and Integrated business process, and streamlining of integration to the back-end systems and multiple SaaS applications.
Case Study
Process Control System Support
In many automated production facilities, changes are made to SIMATIC PCS 7 projects on a daily basis, with individual processes often optimised by multiple workers due to shift changes. Documentation is key here, as this keeps workers informed about why a change was made. Furthermore, SIMATIC PCS 7 installations are generally used in locations where documentation is required for audits and certification. The ability to track changes between two software projects is not only an invaluable aid during shift changes, but also when searching for errors or optimising a PCS 7 installation. Every change made to the system is labour-intensive and time-consuming. Moreover, there is also the risk that errors may occur. If a change is saved in the project, then the old version is lost unless a backup copy was created in advance. If no backup was created, it will no longer be possible to return to the previous state if and when programming errors occur. Each backup denotes a version used by the SIMATIC PCS 7 system to operate an installation. To correctly interpret a version, information is required on WHO changed WHAT, WHERE, WHEN and WHY: - Who created the version/who is responsible for the version? - Who released the version? - What was changed in the version i.e. in which block or module of the SIMATIC PCS 7 installation were the changes made? - When was the version created? Is this the latest version or is there a more recent version? - Why were the changes made to the version? If they are part of a regular maintenance cycle, then is the aim to fix an error or to improve production processes? - Is this particular version also the version currently being used in production? The fact that SIMATIC PCS 7 projects use extremely large quantities of data complicates the situation even further, and it can take a long time to load and save information as a result. Without a sustainable strategy for operating a SIMATIC PCS 7 installation, searching for the right software version can become extremely time-consuming and the installation may run inefficiently as a result.
Case Study
ELI LILLY ADOPTS MICROMEDIA’S ALERT NOTIFICATION SYSTEM
Pharmaceutical production is subject to a strict set of enforced rules that must be adhered to and compliance to these standards is critically necessary. Due to the efforts of WIN 911’s strategic partner Micromedia, Lilly was able to adopt an alarm notification infrastructure that integrated smoothly with their existing workflows and emergency hardware and protocols. These raw energy sources enable the industrial process to function: electricity, WIN-911 Software | 4020 South Industrial Drive, Suite 120 | Austin, TX 78744 USA industrial steam, iced water, air mixtures of varying quality. Refrigeration towers, boilers and wastewater are monitored by ALERT. Eli Lilly identified 15000 potential variables, but limitations compelled them to chisel the variable list down to 300. This allowed all major alarms to be covered including pressure, discharge, quantity of waste water discharged,temperature, carbon dioxide content, oxygen & sulphur content, and the water’s pH.