basic automation engineering, user requirement specifications, functional specifications
hardware and software design specification, description of technological run-off control
electrical and pneumatic engineering, layout and evaluation of field instrumentation, measurement and control equipment
selection of process control systems, PLC, SCADA, visualization systems, layout and specification of interfaces (third party systems)
layout of recipe handling, report management and remote access
Configuration and Programming
programming and configuration of technological sequences
design of visualizations including human machine interfaces are designed according to FDA guidelines and international standards
parameterization of measurement and control devices
set-up of operating systems (virtualized or non-virtualized )
custom specific extensions of existing automation systems, coverage of interfaces to systems not delivered by ISE
documented design methodologies are conceived according to the life cycle model
batch control according to ISA-S88.0 (physical or procedural model), DIN EN61512-1, Namur NE33
Installation and Start-Up
purchase and delivery of process control systems, electrical and pneumatic installations, field instruments
field instrumentation, hardware and software line tests (end to end)
functional tests of hardware and software
factory acceptance tests have been carried out on various projects
setup of aumotation networks - centralized PCS/SCADA systems - decentralized PCS/SCADA systems - virtualized PCS/SCADA systems
Validation
compliance with FDA "21 CFR Part 11" regulation, according to GaMP 4.0 & GaMP 5.0, ISPE Records and Data Integrity Guide
extensive experience in the preparation of risk analysis and traceability matrix related to automation systems
we optimize the validation of our systems by following the GaMP 4.0 & GaMP 5.0 guidelines. Our systems can be validated easily since we guarantee documented quality throughout the whole life cycle of our products.
GMP compliant by using a proven structure for specifications and documentation of hardware, software, measurement and control equipment which are all incorporated in our projects and quality plans.
this includes the execution of test regimes for our products, IQ/OQ protocols and reports, execution of IQ and OQ activities for automation systems
support with the preparation of automation SOPs
advice with the installation of computerized system validation concepts (prospective and retrospective)
Maintenance and Support
24 h customer support for hardware and software, world-wide maintenance contracts
software service on site or teleservice via modem/ VPN/ remote administration software
guaranteed response times, conservation of the validated system status by means of a GaMP compliant on going life cycle
preparation of maintenance plans and operating manuals
