SERVICES

High-level summary of services provided. Please contact us should you have any questions 

Commissioning, Qualification & Validation (CQV)

​Consulting, engineering and life cycle support for engineered process systems including troubleshooting of processes, utilities and facilities:

  • Project Planning and Management - Development of Validation Master Plan (VMP)

  • Risk Assessment and Risk Management

  • Gap Analysis and Remediation Strategies

  • Engineering project’s life cycle documentation such as URS, FRS, DDS, SOPs

  • Design Qualification (DQ)

  • Factory Acceptance Testing (FAT) and Site Acceptance Test (SAT)

  • System Impact Assessments (SIA), Functional criticality assessments (FCAs)

  • Commissioning, Qualification, and Validation (IQ, OQ, PQ, DS, CV, PV, FV) of engineered systems, manufacturing as well as packaging equipment, and process for Bio-Pharma operations

  • Cleaning Validation (CV) - Rinse water recovery studies, CIP, COP, determination of Clean hold time

  • Environmental monitoring and performance qualifications (Cx, IQ, OQ, EMPQ), Airflow Pattern Studies (smoke studies), Facility Pressurization, Thermal mapping, CFD Analysis

  • Process Steaming and Sterilization in Autoclave using clean steam (RQ, IOQ, PQ) – Thermal mapping using Kaye Validator

  • Computer system validation (CSV) - Network / IT Infrastructure Validation - Software Validation

  • Qualification of computerized maintenance management systems (CMMS, ProCAL, etc.)

  • Establishing Critical Quality Parameters, Key and Non-Key Parameters to conduct Risk Analysis as well as Optimize / Value Engineer Project Validation Plan

  • Optimization of engineered systems for operational performance, energy efficiency, leveraging historical dynamic data, customized crystal reports

  • Controls & Automation System Design, Strategy, Troubleshooting, Improvements Testing in Simulated Environment – Debugging, Troubleshooting, FAT, SAT, and Validation – Integration with Historian systems, Data analysis and reporting

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