QCP, Inc. is a leader in compliance consulting services in the Engineering arena supporting Good Engineering Practices (GEP). Our professionals have completed many compliance projects in support of FDA- Regulated companies.
                                     

Engineering Services Supporting:
 

•          Preparing for Validation and Project Document Management–

–        VDRs – Develop Vendor Data Requirements

–        FATs –Testing, document generation, execution

–        SATs – Testing, document generation, execution

–        Commissioning – Testing, document generation, execution

–        TOPs-Turn over Package generation

•          Schedule Activities

–        Procurement

–        In-process inspections

–        FAT

–        System delivery and Installation

–        SAT & Commissioning

–        Validation Activities

•          Process Development Support

–        Develop engineering strategy to introduce new processes

–        Develop Process Flow Diagrams (PFDs)

–        Develop and Conduct  studies to ensure process requirements are being met

–        Develop P&IDs from PFDs

•          Assisting with other activities from an Engineering perspective:

–        Design Reviews

–        System Impact, Critical Component, and Risk Assessments

–        Execution of Validation Protocols

•          Facilitating generation of Engineering SOPs

–        Review current SOPs and update or write as required for GMP use.

–        Change control – mechanical, automation, process

–        Handling of Controlled Drawings

–        Assignment of Drawing Numbers

–        VDRs, Specifications

–        Vendor Audits – raw materials, and equipment

–        Maintenance/Calibration of Validated systems