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.