Validating 3rd Party Software which Tracks Archived Samples

M

Mare74

#1
Hi there,

Our QA manager has given us the task of validating a 3rd party software that we use. It is a sample tracking software that has no affect on the final medical device quality but she wants us to prove it does what we want it to do which is track archived samples. Does she mean software validation or something else?? I'm confused...
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Sure sounds like it... so why are you confused?

Please keep in mind that validation is more than just testing. In your case, does the vendor have a stable and predictable software development methodolgy (SDLC), does the vendor have the means to properly control releases, does the vendor have processes in place to adequately manage problems received and changes made, etc.?

Of course, part of validation in this case WILL be testing so you'll need defined requirements of how the system is supposed to work IN YOUR ENVIRONMENT (i.e., your intended use; not the vendor's list of capabilities).

Does that help?
 

sagai

Quite Involved in Discussions
#3
Hi Mare! (and Yodon of course and all of us :) )

I assume your manager does have a reason why she asks such thing, presumably there may be an internal/external audit finding likely with an open CAPA about it or she sees a potentiality of it.
First I would suggest to clarify the original reason of this duty with her.

I also assume your company is marketing products in the US (but it almost not relevant in this general subject).

Not only the SW has effect on the finished device (direct) quality shall be validated, according to 61 FR 52602, for more see:
http://www.fda.gov/medicaldevices/d...rements/qualitysystemsregulations/default.htm

More precisely you can read the corresponding section of the CGMP at 21CFR820.70(i) see:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Sum it up in this case if this sw is automate/store/etc. any part or subpart of your QMS process it shall be validated.

How ...

There is also a FDA Guidance (CDRH 938) see:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm

And yes, it does not help too much, but there is a detailed almost instructional "well known" method to apply and also still remain conform with CDRH 938, called GAMP, its recent revision is 5, as far as I remember.
See overview:
http://www.slideshare.net/rajsadare/gampriskbased-approch-to-validation
and have a copy from (there is a charge):
http://www.ispe.org/

and now hopefully you are prepared.

Only for informational purposes its also almost in the same way in ISO 13485:2003, see 7.5.2.1 last two paragraph (I think it was an addition to the previous revision of this standard), in this context do not forget about 4.2.4 of this standard.

Before you jump right into a deep water and start an exhausting work, I would suggest to consider the following.
ONLY when the sw system has relevance to CGMP (GxP respectively for collecting GMP/GLP/GCP for different industries) or the previously mentioned 7.5.2.1 section has to have a validated state IN ORDER to comply with regulatory requirements, otherwise I would qualify such work as a hobby in workplace.
I kindly suggest first to evaluate the GxP relevance of this SW first, and if yes, there is (actually it shall be even harder to determine this relevance) a relevance, then consider to use GAMP5 for its validation.

I am getting a long post, so I must stop now. :)

br
Sz.
 
Thread starter Similar threads Forum Replies Date
A Validating my own application developed with Agile Qualification and Validation (including 21 CFR Part 11) 5
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
H Validating Nondestructive leak testing machine Qualification and Validation (including 21 CFR Part 11) 3
S Validating a Bonding Process Qualification and Validation (including 21 CFR Part 11) 3
M FDA's expectation for validating OTS software updates Other US Medical Device Regulations 8
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
J Validating a stopped test due to never finding any defects Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
J Validating multiple injection molding machines efficiently ISO 13485:2016 - Medical Device Quality Management Systems 5
J Grouping Products and Testing Sterile and Biocompatibility - Validating Products Other Medical Device Regulations World-Wide 3
G Validating a Process Based on Lot Release Criteria Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Q Meeting the Requirement of Clause 7.5.2 on Validating Special Processes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
M Validating a Product through Tool Control and Tool Inspections Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
Gert Sorensen Validating a Sandblasting Process - Any pointers? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
G Testing and Validating a New Vertical Milling Machine AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
Q Validating Tape Measures used to Measure Product Conformity to Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Protocol for Validating Pull Tester and Force Gage Qualification and Validation (including 21 CFR Part 11) 9
T Validating Supplier Statement - Rusty shield that supplier denied responsibility Manufacturing and Related Processes 7
Q Validating ESD (Electrostatic Discharge) Flooring ISO 13485:2016 - Medical Device Quality Management Systems 2
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
Q Validating the AOI process (Automated Optical Inspection) Reliability Analysis - Predictions, Testing and Standards 9
K Validating a gage/fixture in-house under TS 16949 - Need information General Measurement Device and Calibration Topics 2
C Validating Custom adaptations of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 11
C Validating a Gage R&R spreadsheet - Defining Formulas in spreadsheet cells Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Gert Sorensen Software Validating Adobe Professional according to Part 11? Quality Assurance and Compliance Software Tools and Solutions 10
D Validating software in materials testing - Integrated system of individual components General Measurement Device and Calibration Topics 3
D Validating Multimeters (how to) General Measurement Device and Calibration Topics 8
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
J Extent of 2017/745: providing 3rd party mass produced devices to NHS patients EU Medical Device Regulations 0
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
J Where I can get a copy of either the 3rd or 4th edition of UL544? Other Medical Device Regulations World-Wide 7
W Internal Auditing carried out by a 3rd party - Review of previous audits AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
M 3rd Party Sorting and Inspection Company Certification Service Industry Specific Topics 4
D Auditing Our Outsourced 2nd-3rd Party Internal Audit Company ISO 13485:2016 - Medical Device Quality Management Systems 6
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
Douglas E. Purdy ISO/IEC 17025:2017 3rd Ed. Changes from 2nd Ed. ISO 17025 related Discussions 6
A CAR from 3rd party AS9100D auditor - Root cause dilemma AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 45
S ISO 9001:2015 Gap Analysis - In-House or 3rd Party? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T List of Tests - IEC 61010-1, 3rd edition and IEC 60601-1, 3.1 edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
O IATF 16949 3rd party auditor training sources IATF 16949 - Automotive Quality Systems Standard 1
O Difference in 60601-1-2 3rd and 4th ed separation RF portable equipment CE Marking (Conformité Européene) / CB Scheme 1
O Standards used for IEC 60601-1-2 3rd ed. Vs. 4th ed. CE Marking (Conformité Européene) / CB Scheme 1
M IATF 16949 - Multiple Locations - 3rd party audit scope IATF 16949 - Automotive Quality Systems Standard 1
J 3rd Party Certification and QMS Revisions Registrars and Notified Bodies 4
Sidney Vianna Proposed Change to 3rd Party Audit Process - Limiting Scope of Audit Registrars and Notified Bodies 19
A How to 3rd Party Audit ISO 9001 Clause 7.1.6 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A How to approach ISO 9001:2015 Clause 7.1.6 when 3rd Party Auditing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Stijloor Calculating (3rd Party) Audit Days for Company with Seasonal Employees General Auditing Discussions 3
C IEC EN 61010 3rd Edition Safety Design Checklist Other ISO and International Standards and European Regulations 3
L Differences in the requirements between IEC 60601-1 3rd ed. and EN 60601-1:2006 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E GR&R ANOVA 3rd Factor for Fixture Nests Using Minitab Software 3
Similar threads


















































Top Bottom