System Process Validation & Qualification

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System Process Validation & Qualification

At Isha’s GMP Consultancy, we provide comprehensive validation and qualification services to ensure compliance with global regulatory requirements for pharmaceutical, biotechnology, and healthcare industries. Our expert consultants help assess products, equipment, and facilities, delivering unbiased evaluations to identify strengths and address weaknesses in your system.

Our Expertise Includes:

  • Programmatic Assistance
  • Development of validation/qualification policies, procedures, protocols, and master plans
  • Technology transfer programs, including processes, analytical methods, and change control
  • Training programs to ensure continued compliance
  • Program assessments to identify gaps and areas of improvement
  • Validation & Qualification Activities
  • Computerized systems & electronic records validation
  • Manufacturing, packaging, and labeling process validation
  • Cleaning, sanitation, and sterilization system validation
  • Facilities, critical utilities, and equipment qualification
  • Analytical method validation & equipment qualification
  • Computer Systems Validation & 21 CFR Part 11 Compliance
  • Development and implementation of risk-based validation strategies
  • User requirements, functional and design specifications
  • IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) protocols and reports
  • Data migration and verification
  • 21 CFR Part 11 compliance assessments, including electronic signatures and data integrity
  • Electronic tracking systems for validation management

With Isha’s GMP Consultancy, you can ensure seamless compliance with global regulatory requirements, enhancing product quality, operational efficiency, and data integrity.

FDA Services