COMECER AUTOMATION

Automation
• Isolator Control System is based on a standard PLC (e.g.
Siemens S7, Allen Bradley, Rockwell, Omrom etc…).
• The programmable logic controller has a modular design.
Its components can be assembled as required for specific
application.
• The control system of an isolator consist of the following
elements:
• A central processing module (CPU)
• Signaling modules for digital and analogue input and output
• Communication processors for bus interfacing
• Remote I/O modules
• Human Machine Interface, HMI.
 Automation
• The Isolator system interface control is realized by a HMI
which ensure the following main functions:
• Access to all defined function selectable by the operator
• Display of all messages and operational
• Entry and editing of all required patrameter settings
• Handling of the access level password
 Compliance to International SW Guidelines and Standards

• GAMP5
The automation compliance to GAMP5 is certified by Comecer
following a development sequence of the project called “Life
cycle“; This certification is performed preparing following
documents, which describe the Hardware functional
charateristics and the validation test sequence:

– FDS (Functional Design Specification)

– HDS (Hardware Design Specification)
– STS (Software Test Specifications)
– HTS (Hardware Test Specifications)
– Change Control

• CFR21 part11
The compliance of software to the regulation CFR21 part11 is
certified by Comecer following a documented analysis of the
regulation requirements; Comecer describes how this
requirements are applied in software development. Also the
requirements of CFR21 part11 are validated with a test protocol
(STS Software Test Specifications).