PHA.SE. Compliance & Validation Services

About PHA.SE. Compliance & Validation Services

  • PHA.SE. Compliance and Validation Services is a Milan-based company – set up in the year 2000 – that prides itself on its expertise and on a dynamic and flexible approach. Over the years the company has consolidated its experience and extended its business to include a broad range of engineering, validation and quality assurance services.
  • PHA.SE. delivers engineering, commissioning , validation, metrology and computer system validation services in accordance with standard, internationally recognized methodologies as well as cGMP regulation, European and US Pharmacopoeia.

  • IT
  • 2020
    On CPhI since
Contact info

Products from PHA.SE. Compliance & Validation Services

  • COMPUTER SYSTEM VALIDATION

    Product COMPUTER SYSTEM VALIDATION

    COMPUTER SYSTEM VALIDATION:
    • Hardware & Software Engineering 
    • Software Development
    • Functional Specification
    • Hardware & Software Design Specification
    • Infrastructural IT
    • Validation Industrial Process 
    •  System AutomationRisk Analysis
  • Validation, Commissioning, Compliance and Computer System Validation

    Product Validation, Commissioning, Compliance and Computer System Validation

    AUDITING: - Support its clients on Vendor Audit; COMMISSIONING:- Manages and performs commissioning activities for new systems, equipments and facilities; 
    TESTING:- Performs the following testing activities using its own instrumentation saving costs and time on tests planning; 
    COMPLIANCE AND VALIDATION:- Supports its Clients on Compliance and Validation services related to either new systems, equipments and facilities and to existing systems (legacy systems); 
    AUTOMATION METROLOGY & VALIDATION: Issue and perform Computer System Validation documentation for the automated system located in the facility (new and existing systems). PHA.SE. carry out these activities accordingly to a GAMP compliant approach in compliance with the international guidelines and regulation (i.e. CFR 21 Part 11, etc.)

PHA.SE. Compliance & Validation Services Resources

  • Brochure PHA.SE. Compliance, Validation & Engineering Services

    PHA.SE. is a Milan-based company -set up in the year 2000- that prides itself on its expertise and on a dynamic and flexible approach. Over the years the company has consolidated its experience and extended its business to include a broad range of engineering, validation and quality assurance services. PHA.SE. delivers engineering, commissioning and validation services in accordance with standard, internationally recognized methodologies as well as cGMP regulation, European and US Pharmacopoeia.