Avraham Harris
Involved In Discussions
Dear Forum members,
I have two questions that are concerning me these days regarding our QMS system.
1) Our company is migrating to a computerized system that will organize and manage a number of aspects of the system (e.g., Document control, change control, training, MRB, CAPA, calibrations and preventive maintenance).
Until now we had a number of forms (controlled with doc. Number, version and date) that would record the various aspects of the above activities/ processes. In the computerized system, there are electronic records that can be created automatically from the database entries, and printed up as a quality record (and signed and dated). How would we maintain control of these records? (They are not forms, and do not have form numbers, versions etc…). Would signing and dating be enough?
I should note that it is a part 11 compliant system. And I would like us to circumnavigate the need for validating their system (e.g., by relying solely on electronic records, and not on hardcopies).
2) I learned this week that according to the ISO/IEC 17025, calibration tags are not necessary (applied by calibrating laboratory), and if they are applied, then they must not contain the next calibration date, unless as a suggestion (and this is only if requested by the customer). Rather, the manufacturer must determine the serviceable status of the equipment and then either 1) apply tags with this info, or 2) store the info on record and ensure that no non-serviceable equipment is readily accessible in the lab for using.
Our old system of tagging was more like a company-applied calibration tag (a concept that does not seem to currently exist). This method did not make any determination of serviceable status, only the actual and next calibration dates.
I am now considering redoing the system, and am not sure what system to prefer (1 or 2) or a third. Do you have a suggestion?
Thank you very much in advance
Avraham
BTW - I have read the thread regarding calibration tags.
I have two questions that are concerning me these days regarding our QMS system.
1) Our company is migrating to a computerized system that will organize and manage a number of aspects of the system (e.g., Document control, change control, training, MRB, CAPA, calibrations and preventive maintenance).
Until now we had a number of forms (controlled with doc. Number, version and date) that would record the various aspects of the above activities/ processes. In the computerized system, there are electronic records that can be created automatically from the database entries, and printed up as a quality record (and signed and dated). How would we maintain control of these records? (They are not forms, and do not have form numbers, versions etc…). Would signing and dating be enough?
I should note that it is a part 11 compliant system. And I would like us to circumnavigate the need for validating their system (e.g., by relying solely on electronic records, and not on hardcopies).
2) I learned this week that according to the ISO/IEC 17025, calibration tags are not necessary (applied by calibrating laboratory), and if they are applied, then they must not contain the next calibration date, unless as a suggestion (and this is only if requested by the customer). Rather, the manufacturer must determine the serviceable status of the equipment and then either 1) apply tags with this info, or 2) store the info on record and ensure that no non-serviceable equipment is readily accessible in the lab for using.
Our old system of tagging was more like a company-applied calibration tag (a concept that does not seem to currently exist). This method did not make any determination of serviceable status, only the actual and next calibration dates.
I am now considering redoing the system, and am not sure what system to prefer (1 or 2) or a third. Do you have a suggestion?
Thank you very much in advance
Avraham
BTW - I have read the thread regarding calibration tags.
