Equipment qualification by ADEODATA

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

The qualifications are performed in compliance with the national and international applicable regulations and guidelines (cGMP, GAMP, FDA, UNI EN ISO 14644-1/2/3/7, ICH and relevant publications e.g. Agalloco).
During the qualification process Adeodata is able to fulfill the following needs:

Risk Analysis/GMP Impact Evaluation

Provision of documents such as VMP, URS, FS, DQ, FAT, SAT, IQ, OQ, PQ, VR, SOP

Commissioning and Decommissioning Activities

 
Thermal Qualifications/Studies
Adeodata provides lethality verification services for equipment such as steam or dry heat sterilizers, sterilizing ovens, lyophilizers, lab incubators and more.

Temperature and Relative Humidity Distribution
Adeodata provides validation and evaluation services on the temperature and/or relative humidity distribution in lab equipment such as stability, photostability and climatic chambers, lab refrigerators, freezers, cryostats, cold chambers and more.

Moreover, we can support you in feasibility studies aimed at selecting environmental monitoring systems for warehouses and storage rooms for controlled temperature and relative humidity products and/or equipment.

Validation of Clean Rooms and Equipment (EU GMP and/or ISO 14644)
Adeodata provides qualification services for HVAC-AHU-Cell Factory systems, lab fume hoods, isolators, Glove boxes, RABS,…
Moreover, we can provide services to start and balance HVAC systems.

Validation of Process Systems/Equipment and utilities
Adeodata provides qualification services (IQ/OQ) for several process devices such as lyophilizers, dessicators, heaters, autoclaves, as well as for utilities (compressed air, medical gases, nitrogen, steam, PW-WFI).

Critical Equipment calibration
By means of specific internal procedures, Adeodata can provide a ISO related calibration service for a wide range of physical quantities (temperature, relative humidity, pressure, high vacuum, speed, time, weight, electrical quantities, flow rate, mass, luminous power, conductivity, pH, Redox, frequency).
Our technical staff is trained and equipped for calibration services on Customer site, directly on systems or equipment, in order to minimize the disruption.
Our service portfolio includes the identification of potential critical calibration systems, the schedule and execution of a periodical calibration plan, special systems calibration (e.g. high vaccum, conductivity, low temperatures,…), as well as the definition and activation of calibration procedures.
Beyond the on-site service, Adeodata is equipped with a laboratory specialized in instrument calibrations and adjusting (e.g. multi-brand Datalogger).
Calibrations, checks, validations and adjusting are performed by means of instruments duly certified by ACCREDIA or equivalents (e.g. DKD, SCS).
For the above mentioned activities, Adeodata can provide paper-less calibration reports with validated software and calculate measurement uncertainty.