To successfully implement the design of a fully validatable facility, it is essential that the design team have a detailed understanding of the regulatory requirements to ensure that they are carried out in a manner that assures regulatory approval.
Engsysco code knowledge and experience ensures that your project will meet or exceed all applicable regulatory requirements for production equipment, piping design and layout, materials construction, movement of materials and personnel, control of environmental conditions, clean in-place and sanitation systems, and critical utilities such as purified water, clean steam, and air.
Engsysco engineers take a comprehensive view of all your compliance needs for FDA approval: from installation, operation, and performance qualifications to cGMP/QSR audits, CFR computer system audits, and documentation reviews. We not only create your validation master plan but also offer all the resources you need to execute an integrated commissioning & qualification program. Our risk-based approach is in line with FDA expectations and ensures an efficient program with assured compliance.