There must be a process to evaluate all new instrument and equipment to verify that they function properly before use.

The installation function check and verify all applicable features.

Verification is a plan to challenge the claims of the manufacturer.  By documenting results of a new or modified process you can ensure the process works as intended and lets you obtain objective evidence.

Validation Process is for the analytic system itself and associated instruments.  Any measured or heat regulated instrument used anywhere in the new testing process must be validated.  Proof that it integrates with the LIMS and changes to computer programs to accomplish the above are documented.

Draft all applicable operating procedures and instruments and document validation.  A written validation protocol provides a temlate so all valid activities can take place and be documented.

Sample Outline for a Validation Protocol:

• Description of the purpose of the validation
• Description of the process or system to be validated
• Description of who is responsible for these activities (preparation of validation plan, equipment installation qualification, operational qualification, process performance qualification, review of results obtained, writing the validation summary)
• Performance of the installation qualification (unpacked, connected, utilities, environment, identification, operator's manual available, procedures, maintenance, calibration and troubleshooting, determine maintenance requirements, determin calibration requirements, schematics available, other unique features, acceptance criteria for installation qualification, initial calibration, record of whether criteria were met)
• Performance of the operational qualification (electromechanical operations, temp of any heat-regulated devices, functionality of alarms or other audible signal, functionality of any visual signals, other unique features, limits and tolerances defined, acceptace criteria for operational qualification, performance using standard samples, record of whether criteria were met)
• Performance of the process performance qualification (process flowchart and procedures, performance qualification plan to include test samples required, material to be used, testing conditions, data to be collected and ID of personnel who will perform the performance qualification.  Acceptance criteria defined, testing process and collection of data, record of where criteria were met and any follow up actions taken, review and approval of performance qualifications)
• Conclusions Made (objective evidence obtained, interpretations, comments and actions, final conclusion, signatures of performers, reviewers and approvers.

Maintenance and calibration:

You must follow the manufacturer's instructions and any accreditation requirements.

Schedule:  what needs to be done, when and who does it.  Include daily, weekly, monthly, quarterly, semi-annually, and annually.

Instructions:  How to do it and how to record that it is done.  You can reference the manufacturers manual or write your own instructions from the manufacturers recommendations. 

Finalize and approve all process and procedure documents including maintenance and calibration.  Train all personnel.  Label equipment and indicate the status of calibration and when the next cal date is due.

Records of equipment history and equipment file contents were emailed to all Caribbean Diagnostic customers in January.