Computerized QMS records and ISO 17025 status tagging

Avraham Harris

Involved In Discussions
#1
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.
 
Elsmar Forum Sponsor

Avraham Harris

Involved In Discussions
#3
Well, let me try to elicit some response:

The initial feedback I received from a colleague who is VP Quality at a medical device company:

To use records produced by the computerized QMS system, we would have to incorporate (through the vendor) into the printed record, a header containing the document number, version number and date.

Has anyone else any experience or insights into this issue?

While I have you on the phone, uhh thread....
- regarding version dates / vs. effective dates. Are effective dates necessary, or can we suffice with version dates. The latter does not say by when the procedure/ WI/ RC etc is to be implemented, Rather only the date the revision was made.

And finally - regarding effective dates - I have a Dir. of Mnaufacturing who feels that the effective date on a route card must be identical to that of the WI it is associated with. Is this true?

Thank you,

Avraham

Moderator - feel free to move this post (copy) to a more appropriate thread (due to the last issue discussed).
 
Thread starter Similar threads Forum Replies Date
A QMS and Computerized Software Compliance with Standards US Food and Drug Administration (FDA) 6
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate Qualification and Validation (including 21 CFR Part 11) 3
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
pbojsen Computerized Learning Management Systems (Training systems) recommendations? ISO 13485:2016 - Medical Device Quality Management Systems 3
K Computerized system Master Validation Plan, IQ-OQ-PQ Draft or Template Qualification and Validation (including 21 CFR Part 11) 4
D Computerized System Validation in Pharma Qualification and Validation (including 21 CFR Part 11) 2
W CPOEs (Computerized Order Entry Systems)? FDA regulated or not? US Food and Drug Administration (FDA) 2
Ron Rompen Computerized Electronic Signatures on Inspection Records Records and Data - Quality, Legal and Other Evidence 8
Q Computerized System Periodic Review Requirement - Pharma Company Qualification and Validation (including 21 CFR Part 11) 7
G ISO 9000 and TS 16949 - CMMS (Computerized maintenance management software) Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Remote QMS Coordinator Position Job Openings, Consulting and Employment Opportunities 0
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 7
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
Q New QMS...Old Projects ISO 13485:2016 - Medical Device Quality Management Systems 5
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
R Gap Audit Aerospsace and Rail QMS Quality Manager and Management Related Issues 0
S AS9120 Store QMS packages AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Disappointed in leadership buy-in to QMS Quality Manager and Management Related Issues 67
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
T How you ensure that QMS is effective and efficient? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 10
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Offsite storage of QMS documents ISO 13485:2016 - Medical Device Quality Management Systems 9
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
DuncanGibbons Model-Based procedures and Architecting the QMS as a System Document Control Systems, Procedures, Forms and Templates 2
SocalSurfer Can you recommend an enterprise QMS for new AS9100 startup AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
H Expanding our business and the implications to our QMS Manufacturing and Related Processes 2
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Is there a better way to do a complete assessment of our QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
qualprod Managing a "special" customer into the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Q AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A QMS Overhaul - Reorganizing and Renaming Documents - Internal References Document Control Systems, Procedures, Forms and Templates 24
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
DuncanGibbons Enterprise Architecture for QMS Conceptualization AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom