IASTECH participated in the development of the control and supervision systems for the following areas:

• CIP and SIP
• Clean Utility Area (Generation and Distribution):
• PTW - Pre-Treated Water
• WFI – Water for Injection
• Clean Steam
• Bottle Inspection Equipment
• Filling Equipment
• Factory Monitoring System (FMS)
• General Utility Area:
• Water Treatment
• Steam Generation
• Hot and Cold Water Generation
• Cooling Towers
• Fuel Storage
• HVAC Monitoring System

The project consisted in developing all the documentation and CLP programs, as well as the SCADA System and validation of the whole computer system. The system was developed in Denmark, where the initial tests and documentation were developed. All the documentation and development of software applications followed the ISA-88 and ISA-95 Standards, in addition to GAMP 4 guidelines. CLP Siemens (S7-400 and S7-300) and the SCADA Proficy iFix System were used, in addition to SQL Server, as data storage for the reports generated in Crystal Report. The plant also uses software for Batch Control and Recipe Management.

The documentation developed for each area was: URS - User Requirement Specification, FS - Functional Specification, RCL - Requirement Classification, SDS - Software Design Specification, SMDS - Software Module Design Specification, TMX - Traceability Matrix, IFA - Interface Agreement, the Validation Protocols, the Validation Test Plans, among others. Our team of engineers has been trained and certified in:

• GAMP (Good Automated Manufacturing Practice)
• CFR 21 Part 11
• Validation of Computer Systems
• Quality Management System - QMS
• Good Manufacturing Practices (GMP) for the EU and USA
• Batch Control System
• Test Preparation Practices
• Test Execution Practices
• Documentation Development Practices