Controlmatic was commissioned to create the software for the entire production process including batch and MIS.
One important point of this project is that CM had to carry out the qualification activities in conformance with GAMP 4 and FDA 21 CFR Part 11.
Scope of Controlmatic's responsibilities:
The entire software was created with PCS7 V6, Batch V6 and MIS-Light. Special requirements of Controlmatic.
The following documents were created: - HDS - Hardware Design Specification
- SDS - Software Design Specification
- SMDS - Software Module Design Spec.
- HFTS - Hardware Functional Testing Spec.
- HFT - Hardware Functional Test
- SFTS - System Functional Test Spec.
- SFT - System Functional Test
- FATS - Factory Acceptance Testing Spec.
- FAT - Factory Acceptance Test
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