Case Studies

Pharmaceutical Automated Processing and Software Validation

Posted in Manufacturing Automation and Intelligence, Pharmaceutical and Medical

Summary

DMC worked with a large pharmaceutical company to develop a system for manufacturing expensive substances used in medical lab work.  DMC assisted with design, programming, validation documentation, and validation testing, ensuring FDA 21 CFR Part 11 compliance.  This system includes automated control over the manufacturing process, web based recipe management and reporting, and a transactional back-end database that requires and logs electronic signatures.

Pharma Automation

Pharma Automation

Solution

DMC was responsible for several facets of this extensive project.  DMC not only designed and implemented each of the many software components of this project, but also wrote the majority of the validation documents and performed most of the validation testing.  The end system is used to develop expensive medical substances that are used for lab tests and blood work.

The system has one central database that contains all stored recipes, manufacturing logs for each batch of material, and logs of electronic signatures required to initiate the manufacturing process and to edit or add new recipes.  This Oracle database is accessible through a web-based interface developed using Microsoft Visual Studio .NET.  The web interface can be used to view or modify recipes and to view manufacturing logs through a reporting system.  The database serves multiple manufacturing stations, each consisting of a PLC that controls the automated manufacturing process and a user interface application for initiating and monitoring the process and entering electronic signatures.  The entire system is secure, with proper credentials (user and password) required at all key points.  All transactions are logged in the database.

DMC worked with the customer's software quality group to ensure FDA 21 CFR Part 11 compliance of the complete system.  DMC developed software life cycle validation documents that fit with the customer's existing validation procedures including User Requirement Specification (URS), Software Requirement Specification (SRS), Software Design Description (SDD), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Risk Assessment, and Traceability Matrix documents.

Customer Benefits

  • Complete install packages and detailed installation and validation documents have allowed the customer to deploy the entire system to other global locations and remain globally competitive
  • Close work with the customer's quality group ensured FDA compliance of the system and facilitated FDA validation, reducing the quality group's workload
  • Detailed transactional database logs with electronic signatures ensured FDA 21 CFR Part 11 compliance and provides traceability for recipe modifications and manufactured substances
  • Robust system for manufacturing process logs data to a local buffer when the network goes down and transmits data to central database when the network is restored, ensuring that expensive material is not wasted
  • Web-based recipe management and reporting system allows secure, remote access to the system from anywhere within company intranet, saving operators, scientists, and engineers' time

Technologies

  • Oracle Database
  • Allen Bradley SLC 500
  • Intellution iFix
  • Microsoft Visual Studio .NET