Documentation and quality systems

Quality is an important aspect of our work. Bioneer's high standards in contract research and project documentation form the basis for fast product commercialisation. Our deliverables the documentation suitable for registration purposes tailored to meet individual needs of our clients.

• Record keeping in compliance with GLP regulations.
• Written procedures are established for “good laboratory practice”.
• A strict policy for documentation of sterilization of laboratory equipment, solutions (buffers etc.) and media.
• Schedules and procedures for the preventative maintenance of laboratory equipment, including assignment of responsibilities.
• Calibration of monitoring equipment in production and laboratory areas according to written procedures on a regular basis. Records of these calibrations are maintained at site.
• All utilities that could impact on product quality (e.g. steam, gases, compressed air, Milli-Q water and ventilation) are appropriately monitored and properly maintained by external service provider.