Servicing Puerto Rico and the Caribbean Islands for more than 20 years

AUDITS

       Bioanalytical Instruments is audited by many pharmaceutical companies and other manufacturers throughout the year, in order to certify us as an acceptable vendor/service provider. This, by reviewing our quality manual, documentation in general and internal records, in order to verify that Bioanalytical Instruments is capable to consistently supply calibration and maintenance services which meet their specifications and expectations.

• Company organization
• Personnel training records
• Calibration and maintenance SOP’s
• Metrology services
• Standards/Test equipments N.I.S.T. traceability
• Handling of test and calibration items
• Calibration records
• Document record keeping
• Documents control procedure
• Preventive actions
• Instrument calibration history records
• Management control
• Subcontracting of test and calibration services
• Others

         Some of the pharmaceutical and manufacturing companies that have audited Bioanalytical Instruments satisfactorily, as an acceptable vendor and technical service/calibration provider are:

                                                          Abbott Medical Optics

Amgen Manufacturing Ltd.   

  Biovail Laboratories

Caribbean Refrescos, Inc. (Coca Cola)   

  I P RPharmaceuticals, Inc. (AstraZeneca)

Pfizer Pharmaceutical

  Roche Diagnostics

Schering Plough Products   

  Steris Isomedix

NOTE:

          As the audits are confidential for distribution within the pharmaceutical/manufacturing companies and auditee only, the same are not published here.