Engineering & Validation

services-star

Reliable products begin with reliable facilities, systems, and processes. GSAP provides engineering, qualification, and validation expertise that helps organizations build compliant manufacturing environments, qualify critical systems, and maintain operational excellence throughout the product lifecycle.

Laborants

1. Biotech, Pharmaceuticals, Advanced Therapies, Combination Products, Hospitals, Food Tech & Medical Cannabis

 

Our services include:

Facility Engineering & GMP Design

  • URS development
  • Conceptual facility and production line design
  • Basis of Design (BOD)
  • Personnel, material, and waste flow optimisation
  • Regulatory submission support for facility approval

 

Critical Utilities & Cleanrooms

  • HVAC and cleanroom design review
  • Purified Water (PW), WFI, Pure Steam
  • Compressed air and process gases
  • Environmental monitoring strategies
  • Cleanroom qualification and compliance with ISO 14644 and GMP requirements

 

Commissioning, Qualification & Validation (CQV)

  • Validation Master Plans (VMP)
  • DQ / IQ / OQ / PQ
  • Facilities, utilities, systems, and equipment qualification
  • Validation protocols and final reports

 

Equipment Qualification & Process Validation

  • Equipment lifecycle qualification
  • FAT / SAT support
  • Manufacturing and laboratory equipment qualification
  • Process validation and qualification activities
  • Automation systems support

 

Computerized Systems Validation (CSV)

  • Validation planning and risk assessments
  • URS / FRS / Design Specifications
  • IQ / OQ / PQ protocol development and execution
  • Data migration validation
  • Traceability Matrix
  • Data Integrity assessments
  • Audit readiness and gap analysis

 

Engineering Compliance & Project Support

  • GMP compliance assessments
  • Regulatory inspection readiness
  • SOP development
  • CAPA support
  • Vendor qualification and technical evaluations
  • Engineering project management and GMP oversight

 

2. Medical Devices, IVD & Laboratories

We provide engineering and validation services supporting medical device and IVD manufacturing environments, laboratory operations, process validation, and computerized systems compliance. Our experts apply risk-based methodologies aligned with FDA, ISO 13485, GHTF guidance, and applicable regulatory requirements.

 

Our Services Include:

Facility Engineering & GMP / ISO 13485 Design

  • Facility concept design and feasibility studies
  • URS development
  • Facility layout and flow optimisation
  • GMP and ISO 13485 design review

 

Cleanrooms & Controlled Environments

  • Cleanroom design and qualification
  • Environmental monitoring strategies
  • HVAC assessment and compliance verification

 

Manufacturing Equipment Qualification & Validation

  • Facilities, utilities, systems, and equipment qualification
  • Equipment lifecycle qualification
  • Supplier evaluation and documentation review
  • IQ / OQ / PQ execution
  • Validation protocols and reports
  • Process equipment and production line qualification

 

Process Validation & Design Transfer

  • Master Validation plans and policy (MVP)
  • Performing risk assessment according to pFMEA
  • Process validation protocol development and execution
  • Validation of special processes according to regulatory requirements
  • Test Method Validation (TMV)
  • Design Controls and V&V
  • Design Transfer and NPI support
  • Statistical techniques

 

Computerized Systems & Automation Validation

  • CSV according to GAMP 5 and FDA 21 CFR Part 11
  • Software lifecycle support
  • Data Integrity assessments
  • Electronic records and signatures compliance
  • CSV gap analysis and audit readiness