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Ancora Imparo
When Michelangelo said these words at the age of 87, he reminded the world that learning never ends. At CONSWELL, we carry this philosophy forward—continuing to learn and grow, together with our partners.
Learn More
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Ancora Imparo
When Michelangelo said these words at the age of 87, he reminded the world that learning never ends. At CONSWELL, we carry this philosophy forward—continuing to learn and grow, together with our partners.
Learn More
About Us
After three years of hands-on laboratory experience, he shifted his professional focus to the fields of validation and qualification. Following his initial training with a Belgium-based organization, he has been actively involved since 2008 in cleanroom operations, sterilization processes, various qualification and validation studies, and laboratory testing activities. Throughout this period, he has worked extensively with Quality Management Systems in accordance with ISO 17020, ISO 17025, ISO 13485, and ISO 15189.
In 2014, he was among the founding members of Aya A.Ş. where he served as General Manager and, in his final year, as Technical Manager. In 2021, he decided to continue his professional journey by establishing his own company, CONSWELL.
Validation - Qualification Services
Click here to learn more about our Installation (IQ) and Operational (OQ) Qualification services.
Sterilization ValidationClick here to validate the sterilization method used for your products.
Software ValidationClick here to validate software embedded in your manufacturing equipment or used to control your overall systems.
Process ValidationsClick here for validation of critical stages in your manufacturing process (Packaging, Stability, Cleaning, Cleanroom Biocontamination, etc.).
Training Services
- ISO 11135 – Ethylene Oxide Sterilization and Validation Training
- ISO 11137 – Gamma Dose Setting and Dose Audit Training
- ISO 11607 – Packaging and Stability Validation Training
- ISO 14644 – Cleanroom Validation Training
- ISO 13060 & EN 285 – Autoclave Validation Training
- ISO 17665 – Steam Sterilization Validation Training
- EN 17141 – Biocontamination Monitoring and Sampling Training
- DIN 1946-4 – Validat...
Audit and Surveillance Services
If you do not have a qualified internal auditor to assess the effectiveness of your Quality Management System, or if you prefer an independent audit conducted by an external organization, you may rely on us. We provide External Audit Services for various Quality Management Systems, including but not limited to ISO 13485, ISO 17020, ISO 15189, and ISO 17025.
Mock Audit
Before undergoing an audit by regulatory authorities or notified bodies, we can conduct a mo...
Consultancy Services
Planning to establish a cleanroom but unsure about the required cleanliness class, equipment selection, or IQ and OQ documentation? At CONSWELL , we are ready to share our experience and guide you through the entire process. If desired, we can engage with our partner companies to obtain alternative proposals and develop the most suitable solution for you. We can also deliver your cleanroom as a fully documented and ready-to-use facility.
- Definition of User Require...