Quality

We put our customers first. By offering user-friendly immunological assays, proficient technical service, and efficient delivery, we aim to always be of service.

We are ISO-certified

We listen carefully to the needs of our customers and respond accordingly in order to build mutually fruitful relations. The aim to satisfy customer needs involves everyone at Mabtech and affects all customer communication. We are proud of continuously receiving numerous positive feedbacks and many returning customers.

Mabtech has chosen to comply with the international standards ISO 9001 and ISO 13485, for the establishment, maintenance and development of its quality management system. The compliance is audited annually by external audits and the certificates have been maintained without interruption since 2006 when Mabtech first aimed for certification.

Compliant readers

The CFR21 part 11 guidelines issued by the US Food and Drug Administration (FDA) regards the use of computerized systems in clinical investigations and how acquired source data must meet the same elements of data quality as that of signed paper records. Mabtech IRIS™ and Mabtech ASTOR™ are controlled by the software Mabtech Apex™ that have been designed to meet the requirements of CFR21 part 11, including history files, limited access, and timestamped audit trails.

 

Additional features beyond the requirements

In addition to the basic criteria of CFR21 part 11, extra layers of control have been added:

  • Well images are processed as image RAW files, containing the untouched signal straight from the sensor. From the moment of capture, RAW files are never compromised by the software. As a result, the original data is maintained and cannot be concealed by any user, including the administrator.
  • Files are individually validated by a checksum verification within the software. Upon reading, each RAW file is passed through a checksum function and a unique block of data is generated.
  • Upon saving, the history audit file is given a unique checksum block of data. Every time a plate is opened, the checksum validation is re-run and controlled against the stored copy, making sure that it matches the original value. If any files are removed, altered, or manipulated, the checksum validation will fail and provide an integrity warning. If no warnings, data integrity is assured.