INTEGRATED ENGINEERING : OPERATIONAL EXCELLENCE

info@profitsengineering.com

  • Home
  • Services
    • Program Mgmt
    • Operational Excellence
    • Technology Implementation
    • CQV-Process
    • CQV-Facilities/Utilities
    • Data Integrity Compliance
    • Shutdown Mgmt
    • NC/CAPA
    • Construction Mgmt
  • Projects
    • Manufacturing Technology
    • Site Development Projects
  • Core Team
    • José Colón Freyre
    • Maria Enid Rosa, PhD
  • About
    • Mission
    • Why Contract Us?
    • Testimonials
  • Contact Us
  • Insights
    • Blogs
    • YouTube Channel Link
  • More
    • Home
    • Services
      • Program Mgmt
      • Operational Excellence
      • Technology Implementation
      • CQV-Process
      • CQV-Facilities/Utilities
      • Data Integrity Compliance
      • Shutdown Mgmt
      • NC/CAPA
      • Construction Mgmt
    • Projects
      • Manufacturing Technology
      • Site Development Projects
    • Core Team
      • José Colón Freyre
      • Maria Enid Rosa, PhD
    • About
      • Mission
      • Why Contract Us?
      • Testimonials
    • Contact Us
    • Insights
      • Blogs
      • YouTube Channel Link

info@profitsengineering.com


  • Home
  • Services
  • Projects
  • Core Team
  • About
  • Contact Us
  • Insights
GENERATE AND EXECUTE PROTOCOLS FOR FAT, IOQ, PQ, CSV FOR EQUIPMENT, UTILITIES AND FACILITIES
COMMISSIONING/QUALIFICATION/VALIDATION

FACILITIES / UTILITIES START UP & CQV

OUR FACILITIES CONSTRUCTION AND DAY TO DAY MANAGEMENT EXPERIENCE ALLOWS TO GENERATE ROBUST TEST SCRIPTS AND BE HANDS-ON DURING THE EXECUTION OF THESE, RESULTING IN RELIABLE VALIDATED FACILITIES WITH MINIMIZED UNPLANNED DOWNTIME.

Find out more

CQV BASED ON FACILITIES MANAGEMENT EXPERTISE

FACILITIES / UTILITIES CQV

We strive to successfully Commission and Qualify Facilities and its Utilities by utilizing our Facility Management expertise to accurately validate designed processes.   We follow U.S. regulation, 21 CFR 211.42 guidelines  for the expected design and construction features.


  • MASTER FACILITIES VALIDATION PLAN: As part of the MVP, strategic steps are highlighted based on industry's best practices and site design.


  • STRATEGIC VALIDATION: Each of the process Critical-to-Function requirements are listed and then added to a Traceability Matrix to assure completion throughout the process. 


  • USER REQUIREMENTS:  We generate the Site User Requirement Specification (URS) and each Utility Equipment as required, based on voice of the customer and product requirements.


  • EQUIPMENT DESIGN QUALIFICATION (DQ): In the DQ we clearly state and reach  agreement on the roles and responsibilities in developing the concept together with the A&E firm and generate a list of the  appropriate qualification documentation (a form of Traceability matrix) required for the Facilities and each utility.  Without this step our clients would be led to a facilities design that is "thought" suitable to meet pharmaceutical GMP requirements. 


  • EQUIPMENT DESIGN: We work with the Original Equipment manufacturers (OEM) for each listed utility (AHU, Chillers, Air Compressors, Purified Water Skids, Steam Generators Skids, Back Up Electricity Generators, etc) to assure capturing design requirements and their capabilities.


  • FACTORY ACCEPTANCE TEST (FAT): We strive to execute FAT documents, when possible, for AHU, Air Compressors etc, to minimized mishaps during on site installation/qualification.


  • INSTALLATION / OPERATIONAL QUALIFICATION (IOQ):  We provide expertise during equipment rigging and  installation.  Our team develops all necessary documents, including Work Orders using your Site's QMS and assure work is compliant.  We coordinate each of the system's start ups with the OEM's and have the install certified by their experts prior to IOQ execution.


  • PROCESS QUALIFICATION (PQ): We are hands-on during the Technician's Certifications to assure expertise during the PQ execution and proper hand-shake with the site Facilities team(s).


  • CLEANROOM CERTIFICATION: We support and manage the cleanroom certification partnering with a qualified agent.  We ensure HEPA filters and Fan Filter Units (FFUs) have a written certification and re-certification schedule. 


Copyright © 2020 Global Procedural Services, dba "Profits Engineering" - All Rights Reserved.

  • Mission
  • Why Contract Us?
  • Contact Us
  • Blogs

PASSION FOR PROFITS. YOURS.

Announcement

 As the COVID-19 pandemic continues to evolve, we are committed to keeping our staff and their families safe. We are also committed to delivering superior results as efficiently as possible and have developed remote working capabilities as well as methods to be on-site safely.  CONTACT US, WE CAN HELP!

Learn more