OUR SERVICES



EQVAL already has been part of successful Engineering and Regulatory Compliance projects. As an example, serving the Pharmaceutical and Medical Devices industries means to comply with the Code of Federal Regulations (CFRs), like 21 CFR Parts 210,211 & 212, and 21 CFR Part 820 for Good Manufacturing Practices (GMPs), and with International Industry Standards like ISO 13485, ISO 14441, ISO 14971, ASTM E2500-07, and ICH Q7,Q8/Q9. ​

Working in compliance with the applicable regulatory standards, some of the services provided by EQVAL Team includes:



ENGINEERING SERVICES





-Process Improvement

  • Production and equipment process improvement, including manufacturing equipment and process review using statistical data and reports analysis (SPC)
  • Six Sigma and Lean Tools (Kappa Testing, 5S)
  • Risk Management, Reliability and Root Cause Failure analysis (Fishbone Diagrams, 6M, 5 Whys, etc. ) ​

-Project Management

  • Project Scheduling and Project Planning of your facilities and utilities construction/improvement projects
  • Project Engineers able to serve your facility's day-to-day management activities or project activities

-Environmental Health and Safety (EH&S) support ​ ​

  • Environmental assessments and research in compliance with federal and local regulations (EPA, EQB, OSHA)
  • Technical support for chemical processes, technology transfer, solvent recovery, and waste disposal (both hazardous and non-hazardous)
  • Technical support on physical/chemical processes for water and wastewater treatment ​

Technical Services Support

  • Facilities and Utilities Maintenance Technicians
  • Manufacturing Equipment Maintenance Technicians
  • High Voltage Elevators Maintenance/Technicians
  • Machine Integration
  • Licensed Electricians

-Architectural / Civil Design

  • Design drawings development: ​
    • As-built, Layouts, Schematics,
    • Architectural, Plumbing/Electrical, HVAC
    • Construction permit assessments
    • Construction on-site inspections Acquiring all Puerto Rico agency construction and environmental permits

-Project Commissioning

  • Start-up and turnover of new facilities, utilities, and equipment to the end-user at manufacturing plants
  • Confirm compliance with design specifications and customer requirements
  • Initial checks in preparation for the final set of inspections and testings


QUALITY ASSURANCE &
REGULATORY COMPLIANCE





-Quality Systems Support

  • Change control management
  • CAPA systems management (Evaluation & Implementation)
  • Internal audits
  • Periodic Reviews
  • Non-conformance (NC) Assesments

-Quality Assurance Support

  • Internal Audits
  • Documentation Revision & Approval
  • Validations & Regulatory Documentation, Revision & Approval
  • Process Improvement
  • Laboratory Project Management
  • Laboratory Test Method Evaluations (including Micro and Analytical Lab support)​


VALIDATION SERVICES





-Process Validation, Equipment and System Qualifications ​

  • Development of Design Documentation (URS, FRS, FDS, SDS)
  • Validation/Qualification Documentation following System Development Life Cycle (SDLC) approach FAT, SAT, IQ, OQ, PQ, PPQ, PV and its corresponding Final Reports

-Utilities and Facilities Qualification

  • Compressed Air Systems
  • USP Water Systems
  • HVAC Systems
  • Building Automation Systems (BAS)
  • Building Monitoring Systems (BMS)
  • Environmental Mappings (Temperature and Relative Humidity)
  • Manufacturing, Laboratory and Clean Rooms Facilities Qualifications ​

-Computer System Validation (CSV)

  • SCADA Systems Validation
  • Automated Manufacturing Equipment
  • Vision Inspection Systems
  • Building Automation Systems
  • CFR Part 11 and Data Integrity Assessments
  • Software Applications Validation ​

-Product and Technology Transfer

  • New Products Introduction
  • Plant Start Up
  • Equipment & Process Transfers ​


STAFFING & PLACEMENT





-Human Resources Management

  • Talent Acquisition
  • Evaluation and selection of highly qualified professionals and managers
  • Evaluation and selection of temporary services and technical positions
  • Incentive and Benefits Programs

​ -Internship & COOP Programs

  • Networking with academic institutions
  • Internships/COOP and part-time opportunities for graduate and undergraduate students


EQVAL TRAINING ACADEMY





Some of our courses are:

  • Understanding the Pharmaceutical & Medical Devices Validation Process
  • Process Validation for Medical Devices
  • CSV for the FDA Regulated Industry
  • Facilities and Utilities Qualification Process (Validations)
  • Lean Manufacturing: Understanding the Key Principles
  • Lean Manufacturing: Process Improvement Tools
  • Understanding Manufacturing Quality Systems: Corrective & Preventive Actions (CAPA)
  • CAPA System: Investigation & Documentation Process
  • Quality Engineering Trainings (ASQ Body of Knowledge)
  • Other courses available ​

*In-house or on-site training available*