SAI is capable of providing software for automation on the control and supervision.
The activities for the realization of the software includes:
DRAFTING SPECIFICATIONS consist of:
- List I/O
- Full List PLC components.
- Wiring Diagram PLC.
- Specifies the logical control of the PLC.
and relative ANALYSIS AND DEFINITION
SOFTWARE PLC/PC (Example)
Control applications are developed for PLCs including the following functions.
- Acquisition of input and output.
- Management Manual Controls Devices.
- Management automatic cycles.
- Management reboot sequence after power failure, partial or total.
- Alarm management.
- Management Network communications with motor drives.
- Managing communication with HMI.
- Managing communication with supervisor stations.
- System Diagnostics.
Panels Operator Software
- Representation of the states of the devices and values in synoptic pages.
- Manual control of devices/utilities.
- Management automatic cycles Pages.
- Windows display settings and adjustments.
- Alarms Pages.
- Manager password access to various functions.
Supervision Software
The provision includes the development and testing of application software oversight Oversight functions include:
- Main menu and navigation tools.
- Representation of the states of the utilities and values in synoptic pages.
- In manual control of the utilities.
- Pages management automatic cycles.
- windows display setting and analog measurements.
- Windows display settings and adjustments.
- analog data recording and representation in the form of trend (in real time and historical).
- Alarm Recording and Display.
- Recording and viewing events related to the processing sequences.
- Manager password access to various functions.
VALIDATION
The Validation Protocol is drawn up according to GMP guidelines (Good Manufacturing Practice) and GAMP (Guide for Validation of Automated Systems in Pharmaceutical Manufacture).
The Protocol Validation contains within itself the Functional Specifications and design of the machine, as well, all the cards necessary for testing the performance of tests to which the machine must be submitted during FAT (Factory Acceptance Tests, or "testing the car at the Manufacturer") and SAT (Site Acceptance Tests, or "testing the machine at user") .
The standard phases of the validation procedure are classified into the following main points:
-
1. Supplies Audits
2. Specification Reviews
3. Functional Specifications
4. DQ - Design Qualification
5. VQ - Vendor Qualification
6. IQ - Installation Qualification (FAT)
7. OQ - Operational Qualification (FAT)
8. PQ - Performance Qualification (FAT)
9. IQ - Installation Qualification (SAT)
10. OQ - Operational Qualification (SAT)
11. PQ - Performance Qualification (SAT)
