Accredited Calibration Sevice Provider using computerized system to issue calibration certificate

#1
Hi all,
I have a following question: We are a accredited calibration service provider (17025 certified), we use internally developed software to produce calibration certificates for our customers.

As calibration records are GxP records for our customers, calibration certificates are GxP records, so our internal system hosting the data used to produce the certificate must be validated.

1. Is Calibration certificate a raw data? Or data used to produce the certificate is raw data which needs to be retained? What is expected from us by the regulated customers in regard to record retention?

2. As this is not COTS software does it fall under GAMP cat. 5 software and require the expanded validation effort? My concern is that as this is an internal SW, we have the opportunity and also need to be able to deploy new versions like patches and bug fixes asap. After major releases we had times where we installed new SW patches weekly, or sometimes even twice a week. We must ensure that SW Validation and mainly IQ will not slow this down or increase effort/costs.

Many thanks for sharing your thoughts on this topic.
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
My initial thought is that your system is more of a 'glorified typewriter' application. But the frequency of major releases makes me question that.

I would not consider the data on the cert to be raw data. But there are a number of questions...

Do you have a back-end database that holds data or do operators directly key in values to the form? Does the software do any validation of the data or is it just using whatever is entered / it gets?

I would presume the certs are 100% inspected for accuracy? If the customer asked for another copy (maybe weeks later), would you provide? How?

I (personally) would not rely on you for record retention. Unless there's something in the contract, that's probably your call.

In all matters like this, risk should be the driver for your actions. Surely you test before rolling out new updates / patches. Don't get too wrapped up in GAMP - it's a framework and a good way to organize, but at the end of the day, you need to just ensure the software operates as intended and risk of it failing are mitigated. Figure out what that means for you / this application.
 
#3
yodon, thank you for your answer.

SW schedules assets calibration, maintains a complete calibration history for all assets, automates data collection during calibration (e.g. by connection to the balance) and performs and documents all calculations associated with asset testing. SW has user management functionality, audit trail, electronic signatures. All changes are stored on the local database and changes require reason for change.

I am not sure about manual entry validation, but at least numerical fields are validating input.

Historical certificates issued by us are held in the SW history as well as meta-data like Next Calibration Date. We do not have any contract about the record retention period about certs or metadata but I started to think what is the original/raw data for the regulated customer in this case? Is it the .pdf certificate issued for the company or is it something from origin, like out meta-data used to create this certificate.

And the last question: if, in the future we will connect this SW to the customer SW to send the .pdf certificate file with associated meta-data, will it change the original data definition and the requirement about record retention period from our side?

Of course we perform tests at every stage of SW development, with each release there is a clear test plan, test cases and documented test runs, and business requirements and defects are maintained by the development team.
 

dwperron

Trusted Information Resource
#4
For 17025 compliance you will need to validate anything that is not COTS software (7.11.2)
The calibration certificate is a record, not data.
Record retention is required, you set the retention time.
You will need to retain the calibration data that you collect under section 7.5 Technical Records. Under the old 17025 you were required to save data such as work sheets, check sheets, work notes, customer notes, "papers" , etc. It is more practical now - you need to retain whatever is necessary to duplicate the calibration.
The customer getting a copy of the .pdf of the certificate makes that their record that they will need to retain per their policy. That will not affect your retention of your record of the calibration.
 
Thread starter Similar threads Forum Replies Date
M Accredited Calibration Sevice Provider using computerized system to issue calibration certificate General Measurement Device and Calibration Topics 2
I IATF 16949, accredited logos, calibration capabilities, etc. IATF 16949 - Automotive Quality Systems Standard 17
S Is it mandatory for a Calibration Lab to be ISO 17025 accredited? General Measurement Device and Calibration Topics 7
P ISO 9001 Requirements for ISO 17025 Accredited Calibration Laboratory ISO 17025 related Discussions 5
Crusader Calibration Source not ISO 17025 accredited ISO 17025 related Discussions 6
E Should companies that perform calibration services be ISO 17025 accredited? ISO 17025 related Discussions 13
N Internal Calibration vs. Accredited Calibration for Balance - Differences Calibration Frequency (Interval) 3
N Calibration Lab unable to issue Accredited Certificate when error is too high? General Measurement Device and Calibration Topics 3
K Survey Meter Calibration - Accredited Laboratory required? General Measurement Device and Calibration Topics 5
M ILAC p14:12/2010 - Accredited Calibration Certificate Uncertainty General Measurement Device and Calibration Topics 2
A ISO 17020 Audit Findings - Calibration from Accredited Laboratory required Other ISO and International Standards and European Regulations 8
H Finding an ISO 17025 accredited laboratory to perform calibration ISO 17025 related Discussions 14
C Accredited Calibration Certificate Content - ISO 17025 Section 5.10.4.2 Question ISO 17025 related Discussions 7
J Compliant Calibration vs. Accredited 17025 Calibration - 1000ml Graduated Beaker ISO 17025 related Discussions 16
S Calibration of equipment in an A2LA accredited testing laboratory General Measurement Device and Calibration Topics 7
M Accredited Laboratory for Calibration of a Radiometer General Measurement Device and Calibration Topics 7
K Suggestions for a Low Cost Accredited Calibration Laboratory - Ring Gages General Measurement Device and Calibration Topics 8
M Any News about the FAA 14CFR Part 121 / 145 Requiring Accredited Calibration? Federal Aviation Administration (FAA) Standards and Requirements 3
S Calibrating Biomed equipment in an ISO 17025 accredited calibration laboratory ISO 17025 related Discussions 5
J Using Outside Accredited Calibration Laboratories vs. In-house Calibrations General Measurement Device and Calibration Topics 10
R Outside Calibration - Accredited, certified - Is NIST traceability guaranteed? General Measurement Device and Calibration Topics 8
C Are accredited calibration laboratories more profitable than non-accredited General Measurement Device and Calibration Topics 4
J ISO 17025 Accredited Calibration of Ultrasonic Thickness Tester ISO 17025 related Discussions 6
T Calibration Waiver - Calibration by OEM who is not accredited General Measurement Device and Calibration Topics 2
J QS-9000 Clause 4.11.2.b.1 - Calibration by OEM vs. Accredited Laboratory QS-9000 - American Automotive Manufacturers Standard 6
B Directory of Largest Global Certification Bodies (Accredited) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
B Accredited laboratory or not under MDD 93/42/EEC IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
W ISO standards /Social Audit Franchise (Accredited & Non Accredited) Service Industry Specific Topics 6
D Who are the accredited Certified Bodies for CE Mark for Medical Devices? CE Marking (Conformité Européene) / CB Scheme 7
Jen Kirley Is your registrar (CB) accredited? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 9
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
Q ISO 14001:2015 accredited but import most product - CB Raised minor NC on Life Cycle Perspective ISO 14001:2015 Specific Discussions 2
S CB accredited by non-aligned AB - industry views? ISO 13485:2016 - Medical Device Quality Management Systems 1
I ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification) Coffee Break and Water Cooler Discussions 1
B AS9100 - Are special process suppliers required to be NADCAP accredited? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 15
I FAR Part 43 and Application to 17025 Accredited Cal Lab Federal Aviation Administration (FAA) Standards and Requirements 2
Sidney Vianna IAF Endorsed Accredited 13485 Certification helping Control of Medical Distributors ISO 13485:2016 - Medical Device Quality Management Systems 0
M BS 10008:2014 Registration - UKAS accredited company in the UK to assess our company IEC 27001 - Information Security Management Systems (ISMS) 4
JoCam Use of ISO Logos if company is not certified by an accredited certification body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
C CB Accreditaton - CB that was accredited by IAS Registrars and Notified Bodies 5
S Do Microbiology Testing Labs need to use ISO 17025 accredited vendors? ISO 17025 related Discussions 2
L What are Accredited laboratories? (Medical Device Class IIb Related) EU Medical Device Regulations 1
Sidney Vianna Interesting Discussion IAF CertSearch Database - Repository of "properly" Accredited Management System Certs ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 74
DietCokeofEvil How is it that gage manufacturers are not required to be accredited? General Measurement Device and Calibration Topics 9
A How many laboratories are accredited to ISO 17025 in the USA? ISO 17025 related Discussions 5
B ISO 17025 Accredited Certificate Requirements ISO 17025 related Discussions 2
Ajit Basrur ICCBBA Is Now an FDA-Accredited Issuing Agency for Unique Device Identifiers (UDI) Other US Medical Device Regulations 1
U Once upon a QMS - Is a Statement of Uncertainty a must for ISO 17025 accredited labs? ISO 17025 related Discussions 8
N How Do I Make a Business Plan - 17025 Accredited Laboratory ISO 17025 related Discussions 3
Similar threads


















































Top Bottom