Pharmaceutical Validation

Commissioning, Qualification and Validation Services

We provide our clients with GxP and GMP services including auditing, inspection preparation, Raw Data Handling, Inspection remediation and QA support.  our goal is to help clients ensure their facility, utilities, and equipment perform as intended. We do that through commissioning and qualification services, using a risk-based approach to maximize time and cost efficiencies through focused qualification efforts. Our Validation consulting team can provide the following validation services for any GMP system:

  • Computer System Validation
  • Equipment Validation
  • Facility Validation
  • Utility Validation
  • Lab Instrument Validation
  • Cloud based SAAS Application Validation

Validation Documentation

ACR Technology validation services is supported by the fact that we are employer of well trained Validation Engineers and can offer Validation Consultants and/or Validation Contractors to support you throughout the validation life cycle projects. They will use a risk-based approach to focus scarce resources only what needs to be validated to ensure product quality and patient safety. Our Validation Engineers are experts in developing below validation documentation:

  • Validation Master Plan
  • System Impact Assessment
  • GxP Applicability and Criticality  Assessment
  • 21 CFR Part 11 Assessment
  • Risk Assessment FMEA
  • User Requirement Specification
  • Functional Specification
  • Design Qualification
  • Factory Acceptance / Site Acceptance / Commissioning Test
  • Installation Qualification / Operational Qualification  / Performance Qualification
  • Requirement Traceability Matrix
  • Validation Summary Report
  • Change Control, CAPA and Deviation records
  • Periodic Review of all GMP Systems
  • Data Integrity Assessment
  • Gap Analysis
  • Remediation Plan 
  • Scheduled and Unscheduled Re-Validation