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GAMP Methodology
Optimation’s experience with GAMP 4 and 5 projects includes
lab system, pilot lines, production systems, high-speed
test systems, flexible dosing, centrifuge / dryer systems,
process air systems, fermentation, sterile filling, batching,
medical testing and more.
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Project Execution
Through years of work with pharmaceutical clients, Optimation has a project execution methodology similar to the GAMP V-model for computer validation. Optimation endorses the GAMP V-model and modifies it as required to fulfill the customer's needs while providing a quality project execution strategy.
- User Requirements Preparation: Prepare User Requirements Specification (URS) and bid packages for your project requirements. This typically involves site surveys and customer consultations.
- Functional Specification Preparation: Develop a system Functional Specification (FS) for your project requirements. This typically defines the system object and component functionality.
- Detailed Design Specification Preparation: Develop a system Detailed Design Specification (DDS) for your project requirements. This typically defines the details of the system design enabling software and hardware to be built as well as test protocols to be developed.
- Design: From mechanical and process through electrical and software engineering, Optimation provides a great breadth and depth of design services. Software design uses off-the-shelf or custom software or a combination of both to satisfy the requirements of your application. Our experienced engineering staff will provide you with an efficient, cost effective solution utilizing any combination of PLC's, controllers, DCS's, and computers. All software is fully documented for future reference. Mechanical and E/I Designers and CAD drafters provide drawings and documentation packages to suit any need from system configuration to conduit and cable schedules.
- Fabrication Services: Fully equipped shops, providing a single point of responsibility. Our skilled trades employees are capable of performing all of the tasks required to produce a quality finished product.
- System Simulation: Provide system checkout prior to shipment. Time invested during a simulation is very well spent when measured against time and expense saved at field start-up. All system components and software can be challenged to ensure compliance to system design.
- Installation and Start-Up: Provide system installation, installation assistance and start-up assistance. Our engineers are experienced in making installation and start-up as painless as possible, sensitive to production shut down limitations.
- Validation Services: Provide IQ and OQ protocol development and implementation services for regulated industry clients.
- Training Manuals and Classes: Prepare operational manuals to assist customers in using the system. We can also provide training classes at our facility or at your site.
- Calibration Services: Provide NIST Traceable calibration services for initial instrument installation, as well as calibration services under ongoing contracts.
- Software, Hardware and System Support: Provide continuing support contracts that cover up to 24 / 7 services.
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