Pharmaceutical

Design and Implementation of Validated Projects to satisfy TGA and FDA audit requirements for the project implementation and on-going production.

Projects are implemented in accordance with Good Automated Manufacturing Practise (GAMP). Computer system validation following GAMP guidelines requires users and suppliers to work in concert so that responsibilities regarding the validation process are understood. For users, GAMP provides a documented assurance that a system is appropriate for the intended use before it goes “live.” Suppliers can use GAMP to test for avoidable defects in the supplied system to ensure quality product leaves the facility.

The GAMP framework addresses how systems are validated and documented, in other words “how one will validate and document the system.” Companies do not need to follow the same set of procedures and processes of a GAMP framework to achieve validation and qualification levels that satisfy inspectors. Instead, GAMP examines the systems development lifecycle (SDLC) – a conceptual model that lays out the deliverable documents required by GAMP – of an automated system to identify issues of validation, compliance and documentation.

Machine Control

Systems designed and implemented with speed, efficiency and reliability in mind.

New technologies provide cost effective solutions for complex machine operation.

• Stand Alone Machines
• Production Line Integration

Power

Generation

Energy Consumption Control and Monitoring

Building Power Management, Load Shedding, Power Factor Correction