cGMP Compliance & GAMP
NeoDyne specialises in integrating Automation, Process Control and MES projects for Life Science customers in Ireland. NeoDyne designs, develops and implements GAMP5 control systems which achieve compliance with customer standards and regulatory guidelines. We focus on configuring software and hardware to maximise capability in meeting all regulatory needs.
Our typical projects include automation control systems for vendor package equipment (VPE) and bespoke ‘Stick Build’ systems. We interface these systems to the plant industrial Ethernet network, which provides the infrastructure for application servers and virtual machines. We have completed projects within production suites, provision of clean utilities (WFI, PW, CIP, SIP) and water treatment.
We typically provide the following services:
- Supply of PLC, server and client hardware
- Design, build and testing of electrical panels for control system
- Design, build and testing of PLC, SCADA and Software to ISA S88.01, ISA95 and ISA101
- Factory Acceptance Testing (FAT) including integration verification of all hardware
- Delivery of Control System Life-Cycle Documentation to current GAMP guidelines
- Commissioning, start-up on site and site acceptance testing, including IQ / OQ support
Working with process owners and end-users, we help identify the technological solution that best meets our customer’s needs. We work with a variety of technologies from leading vendors including Aveva (Wonderware), Siemens, Rockwell, Schneider, Mitsubishi and ABB. We have deployed process automation solutions across the Pharma, Food & Beverage, CPG and Power Generation sectors.
Many of our projects involve zero-interruption tolerance applications for which structured software design is essential to achieve the required level of reliability. We develop standard hardware high availability solutions such as redundant PLCs and redundant power supplies and also provide high availability process visualisation /SCADA solutions using terminal services, redundant servers and virtualisation.
Understand and Plan
- Assess process and identify requirements
- Agree Production/ Compliance goals
- Identify Cost Reductions
- Identify Reliability Improvements
- Identify Safety Improvements
- Integrate with on-site management/planning tools
Design and Build
- Solution design using ISO 9001 accredited design process
- Produce deliverables to align with customer lifecycle requirements (FS, SDS, HDS)
- Produce client-reviewed design documentation, including wiring schematics and functional specifications
- Complete full software and hardware Factory Acceptance Testing (FAT)
Commission, Qualify & Support
- Comply with customer and regulatory standards and requirements
- Install & commission system with customer project team (electrical, mechanical, process C&Q)
- Produce and execute site acceptance test protocols as necessary
- Provide life-cycle support of systems and 24/7 on-call service