ADEODATA SA

About ADEODATA SA

We provide consulting services to several Life Science companies of the Italian, Swiss and international market, working in the pharmaceuticalAPIs (Active Pharmaceutical Ingredients) and medical device field. Our consulting activity includes qualification and validation services, instrument calibrations and Data Integrity remediations.

  • PLANT, EQUIPMENT AND SYSTEMS QUALIFICATIONS
- Environmental Classification (ISO 14644 and/or EU GMP)
- Qual

  • CH
  • 2019
    On CPhI since
Contact info

Products from ADEODATA SA

  • QUALIFICATION OF PROCESS EQUIPMENT

    Product QUALIFICATION OF PROCESS EQUIPMENT

    Even if the qualification of the equipment is probably the activity practiced by the greatest number of institutions of the most varied types (consultants, builders, fonitors, ...), Adeodata stands out for a structured approach based on experience, continuous updating and organization that guarantee an approach that is always in line with regulatory requirements.

    OUR COMPETENCE AND EXPERIENCE

    Right here Adeodata makes the difference. Adeodata established the figure of a SME (Subject Matter Expert). which is part of the method based on the procedures of the quality system of Adeodata certified ISO 9001: 2015.
    In particular, the SME is expected to:
    • study the regulations (and related updates);
    • update the internal standards, also collecting the experiences in the face of new qualified equipment;
    • instruct all consultants on these standards.
  • COMPUTERIZED SYSTEM VALIDATION

    Product COMPUTERIZED SYSTEM VALIDATION

    Since 2000 Adeodata is specialized in the computerized systems of the pharmaceutical industry: from validation to Data Integrity assessment and remediation of systems in the range from simple PLCs on board of production equipment or laboratory equipment, up to more complex systems, such as management systems (ERP, MES LIMS, document management systems ...). Doing this, it is necessary to analyze the organizational processes (the context in which the system is used) and to identify critical functions for GxP purposes, in order to focus the validation activities making the effort sustainable.
    The inspectors' requests evolve according to new regulations or guidelines (as for Data Integrity) and the validation documentation must be constantly updated.

    OUR COMPETENCE AND EXPERIENCE

    Right here Adeodata makes the difference. In fact, the experience, the continuous updating and the competence of our consultants guarantee an approach that is always in line with the regulatory requirements. This is why Adeodata has put these factors at the center of its quality system and invests 5% of its turnover in:
    • studying of the regulations (and related updates) by the dedicated staff (Subject Matter Expert - SME) which participates in the national and international work groups that issue and maintain the guidelines (these include the Good Practice Guides of GAMP and ISPE);
    • updating the internal standards, also for the new systems that have been validated;
    • training of all its consultants on these standards (on average from 5 to 15 days / year of training and support, respectively for senior consultants and new hires).
  • QUALIFICATION OF DEPARTMENTS WITH CONTROLLED CONTAMINATION AND THERMAL MAPS

    Product QUALIFICATION OF DEPARTMENTS WITH CONTROLLED CONTAMINATION AND THERMAL MAPS

    If the thermal mapping of warehouses and storage areas of the materials along the entire production and distribuition chain is complicated because of the heterogeneity of the environments and of the conditions (just think about the transporters), the qualification of production locals or of laboratories with controlled contamination requires specific specialized skills, including multidisciplinary ones, considering the intervention of microbiologists.

    Adeodata stands out for its structured approach based on competenceexperience, continuous updating and organization that guarantee an approach that is always in line with regulatory requirements.

    OUR COMPETENCE AND EXPERIENCE

    Right here Adeodata makes the difference. Adeodata established the figure of a SME (Subject Matter Expert). which is part of the method based on the procedures of the quality system of Adeodata certified ISO 9001: 2015. In particular, the SME is expected to:
    • study the regulations (and related updates);
    • update the internal standards, also collecting the experiences in the face of new qualified equipment;
    • instruct all consultants on these standards.
    INSTRUMENTATION

    Adeodata has extensive instrumentation (particle counters, photometers, wired or wireless dataloggers) and related software compliant with Data Integrity requirements, validated and periodically calibrated.
  • INSTRUMENT CALIBRATION

    Product INSTRUMENT CALIBRATION

    For the calibration of the instruments, Adeodata stands out for its competence and organization. Adeodata guarantees the use of reference instruments with the necessary accuracy and referable to international standards that allow it to calibrate the instruments, not only in the most common measurement ranges, but also the most difficult ones like: 
    • Conductivity: starting from 0.06 µS / cm 
    • Flow rate: up to 34,000 l / h (ultrasound) or up to 2.800 kg / h (mass)
    • Vacuum: down to 10^-6 (for freeze dryers)
    • Pressure: up to 600 Bar
    • Temperature: from -196 to 700 ° C
    • Radiometric measurements: UVA, UVB, UVC, lux up to: 50 W / m2, 30 W / m2, 1.5 W / m2, 4000 lux (for pass-boxes and photostability rooms)

ADEODATA SA Resources

  • News Equipment qualification by ADEODATA

    We provide consulting services to several Life Science companies of the Italian, Swiss and international market, working in the pharmaceuticalAPIs (Active Pharmaceutical Ingredients) and medical device field.