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Structure Validation Methodology
The Structure Validation Methodology is focused on satisfying the needs of the customer with a sound validation process. Many of our consultants are experts in this process. Starting with a sound validation plan, we believe this methodology covers all the steps needed to ensure your process and equipment conforms to all necessary regulation to keep your business operating at peak levels. Production systems validation capabilities include all types of manufacturing in medical device, pharmaceutical, and biotechnology processes. Computer systems validation encompasses PLC, SCADA, DCS, smart process controls, network communications, and higher level computer management systems, such as MRP and SAP. For new facilities, Structure Validation's experts employ the life cycle concept, integrating the validation process with engineering, design, and construction. The steps involved in this process include: technology transfer, conceptual design, engineering, procurement, construction, validation, and systems integration. Validation begins with input and spans: audits, master planning, design review, protocol development, construction/installation review, IQ/OQ/PQ, summary reports, and regulatory agency review. Experience has shown that integration of cGMP compliance and validation early in any project minimizes validation costs and enhances operational efficiency. For existing (legacy) facilities, equipment and processes, Structure Validation will conduct an assessment of your operation including a gap analysis/risk assessment of your deviations/areas for improvement. We will recommend an action plan and guide you through the process of implementation. |