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Validation

Validation
Product Description

CSV Group high skilled team supports a wide range of GxP critical environments, with profiles dedicated to strategical GxP Activities for Risk Management as well as to computerized Systems and Data Integrity.

COMMISSIONING

  • FAT/SAT assistance/ support
  • System balancing and troubleshooting
  •  Instrument calibration

QUALIFICATION
  • URS 
  • VMP 
  • GMP review 
  • DQ, IQ, OQ, PQ protocols writing and execution
  • Risk and impact assessment strategy
  • Process, cleaning and methods validation 
  • QA & QC SOP writing 
  • Computer system validation
  • Data integrity assessment

 

CSV Life Science ( S.R.L.)

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service
Specifications
  • Selling Points
    Experienced Technicians; International Approvals/Standards; Quality Service
  • Supplied from
    Italy

CSV Life Science ( S.R.L.)

  • IT
  • 2015
    On CPHI since
  • 2
    Certificates
  • 100 - 249
    Employees
Company types
Contract Service

More Products from CSV Life Science ( S.R.L.) (11)

  • PROCESS SYSTEMS SUPPLY AND PRODUCTION

    Product PROCESS SYSTEMS SUPPLY AND PRODUCTION

    Through Pharma Hub, we provide tailor-made systems for process plants in the pharmaceutical market. The design and construction of process plants require specific skills aimed at meeting all customer needs, taking into account many variables, including the type of product to be produced and the possibility...
  • CONSTRUCTION

    Product CONSTRUCTION

    The construction division of CSV Life Science is able to support clients during the construction phases, providing turnkey plants (Lump Sum Turn Key, LSTK) as well as Project Management and Construction Supervision site services. For each project, CSV relies on a team of experts, led by a Constru...
  • CONTAINMENT

    Product CONTAINMENT

    Csv Life Science offers containment solutions for high potent API design, construction and integration. Services:  • Full CGMP design and CFR 21 part 11 compliance • OEB 4 to 6 containment strategy definition and equipment manufacture • Exposure control procedures definition • A...
  • ENGINEERING

    Product ENGINEERING

    Csv Life Science offers Conceptual, Basic and Detail Engineering services.
  • EQUIPMENT MANUFACTURING

    Product EQUIPMENT MANUFACTURING

    CSV Life Science Group, aiming at controlling all the steps of its production processes, manufactures all the equipment for isolation technology as well for liquid preparation through its Rome based metal workshop fully dedicated to pharmaceutical machine
  • Facility Planning

    Product Facility Planning

    Csv Life Science can support customers  in all phases of the project, right from the very beginning. This includes facility planning activities, aimed to a better and conscious defnition of your new or upgraded process needs

  • API TRADING

    Product API TRADING

    CSV Life Science Group through CSV Active division offers a complete side-by-side service for API and Fine Chemicals strategic sourcing, complying with its cGMP quality system, which is constantly subject to audits of regulatory authorities.
  • PROCESS EQUIPMENT FOR LIQUIDS

    Product PROCESS EQUIPMENT FOR LIQUIDS

    PharmaHub, as part of CSV Life Science Group, is a reliable supplier for a wide range of equipment for liquids drugs preparation         • Mixing tanks • Solution preparation packages  • Transfer lines • CIP/SIP skids • Turboemulsifiers • Mobile stirred vessels • Ful...
  • APIs TRADING

    Product APIs TRADING

    With CSV Active, we complete our range of services offered in the life science sector. We are a reliable and competent partner for the research and commercialization of intermediates and active ingredients and operate mainly in the Middle and Far East, boasting an extensive network of contacts with highly ...
  • CONTAINMENT

    Product CONTAINMENT

    Our CSV Containment division is specialized in the design, construction, and integration of containment systems for high-potency APIs. The products, manufactured in our Italian facilities, can meet the most demanding requirements thanks to a deep understanding of the processes to be contained. We offer bot...
  • ENGINEERING AND GMP SERVICES

    Product ENGINEERING AND GMP SERVICES

    Our historical branch, CSV Life Science, has been providing engineering and validation services for the Life Science sector (Chemical-Pharmaceutical, API, Biotechnology, Nutraceutical, and Medical Devices) for 25 years. We are among the first companies in Italy to provide engineering solutions and implemen...

CSV Life Science ( S.R.L.) resources (5)

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  • Product IT and OT Infrastructure Qualification

    Global Verification & Validation is a SaaS solution for Life Science companies that complies with EMA/FDA. FIVE Validation developed a SaaS platform that allows validation studies to proceed 6x faster than a manual (electronic or paper-based) process.

  • Product Quality & Compliance Solutions


    From early-stage development through commercial support, our experts provide critical GxP-based consulting services. We partner with clients to successfully execute projects throughout the product lifecycle to maintain quality & compliance with applicable regulations and industry standards. qq...
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  • Product Computer System Validation (CSV) Solutions

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  • Product Modular Cleanroom Panels , Electrical & HVAC Systems

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    Qualipharma is a consulting company created in 2001 and specialized in GMP&GDP advisory and consultancy services for healthcare and pharmaceutical sectors. Nowadays, our company is made up by a team of 80 experienced professionals that guarantees the highest quality customer service experien...
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  • Product EQUIPMENT MANUFACTURING

    CSV Life Science Group, aiming at controlling all the steps of its production processes, manufactures all the equipment for isolation technology as well for liquid preparation through its Rome based metal workshop fully dedicated to pharmaceutical machine
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  • Product Life Science: Computer System Validation

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  • Product ENGINEERING AND GMP SERVICES

    Our historical branch, CSV Life Science, has been providing engineering and validation services for the Life Science sector (Chemical-Pharmaceutical, API, Biotechnology, Nutraceutical, and Medical Devices) for 25 years. We are among the first companies in Italy to provide engineering solutions and implemen...
  • Product CONTAINMENT

    Csv Life Science offers containment solutions for high potent API design, construction and integration. Services:  • Full CGMP design and CFR 21 part 11 compliance • OEB 4 to 6 containment strategy definition and equipment manufacture • Exposure control procedures definition • A...
  • Product CONSTRUCTION

    The construction division of CSV Life Science is able to support clients during the construction phases, providing turnkey plants (Lump Sum Turn Key, LSTK) as well as Project Management and Construction Supervision site services. For each project, CSV relies on a team of experts, led by a Constru...
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    Quality management systems (QMS) are crucial for the success of any business. They provide an accurate way to track and measure quality across all areas of your company. One key benefit of a quality management system is that it establishes clear goals, roles, and responsibilities. It also tracks the pr...
  • Product ENGINEERING

    Csv Life Science offers Conceptual, Basic and Detail Engineering services.
  • Product Facility Planning

    Csv Life Science can support customers  in all phases of the project, right from the very beginning. This includes facility planning activities, aimed to a better and conscious defnition of your new or upgraded process needs

  • Product PROCESS SYSTEMS SUPPLY AND PRODUCTION

    Through Pharma Hub, we provide tailor-made systems for process plants in the pharmaceutical market. The design and construction of process plants require specific skills aimed at meeting all customer needs, taking into account many variables, including the type of product to be produced and the possibility...
  • Product PROCESS EQUIPMENT FOR LIQUIDS

    PharmaHub, as part of CSV Life Science Group, is a reliable supplier for a wide range of equipment for liquids drugs preparation         • Mixing tanks • Solution preparation packages  • Transfer lines • CIP/SIP skids • Turboemulsifiers • Mobile stirred vessels • Ful...
  • Product CONTAINMENT

    Our CSV Containment division is specialized in the design, construction, and integration of containment systems for high-potency APIs. The products, manufactured in our Italian facilities, can meet the most demanding requirements thanks to a deep understanding of the processes to be contained. We offer bot...
  • Product IT and OT Infrastructure Qualification

    FIVE resources have access to the GO!FIVE® digital validation software at no additional cost, accelerating the validation process and ensuring transparency. You can track the project's progress in real-time, enhancing communication and decision-making.

    For software validation, all validat...
  • Product API TRADING

    CSV Life Science Group through CSV Active division offers a complete side-by-side service for API and Fine Chemicals strategic sourcing, complying with its cGMP quality system, which is constantly subject to audits of regulatory authorities.