The Design Phase of a project offers the greatest amount of flexibility, and yet has the greatest potential for regulatory non-compliance. The decisions made at this juncture have a profound effect upon the life-cycle of the project. Regulatory Compliance Associates Inc. has the technical and regulatory expertise necessary for efficient, compliant, successful implementation of the Design Phase for new projects. From conceptual design development, through design criteria identification, to validation master planning, Regulatory Compliance Associates Inc. will assist in making the correct compliance choices, to ensure the long-term success of the project.
Regulatory Compliance Associates Inc. will provide the following concept development services:
- Process, Material, and Personnel Flow Concepts
- Site and Facility Layouts
- Facility Design Criteria
- Facility, Process, and Automation Control Philosophy
- Contamination Control Philosophy
- Validation Master Plan Development