​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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