Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market?

in case of purchasing controls, should requirements be met such that

  • pre-requisites in above example, to be in place before purchase order

    Votes: 1 100.0%
  • before batch release, all the above points to be in place before batch-initiation or batch-release.

    Votes: 0 0.0%
  • Others!!!

    Votes: 0 0.0%

  • Total voters
    1
  • Poll closed .

v9991

Trusted Information Resource
Subpart E--Purchasing Controls
Sec. 820.50 Purchasing controls.
above requirement translates to "evaluation of supplier" - specification - quality agreement - and 'type&controls"

in order to comply with the requirement(s), for that matter any one.,
should we

option 1:- all the above mentioned relates are pre-requisites for purchase requisition.
option 2 :- all the above points to be in place before batch-initiation and batch-release.


in my earlier post, I could not really focus this aspect of the subject ..
https://elsmar.com/Forums/showthread.php?t=69475
 

shimonv

Trusted Information Resource
Re: is the 'compliance' an pre-requisite or is it ok before batch release to market

I think it depends on where you are at in the product life cycle phase.
If you are in a early research phase it is not necessary, but your procedures needs to back it up.

If you are in the development phase the purchasing controls have to be in place because you want your product V&V to be valid and representing the final product for release.

During limited or mass production purchasing controls must be in place to insure product quality.


-Shimon
 

v9991

Trusted Information Resource
Re: is the 'compliance' an pre-requisite or is it ok before batch release to market

I think it depends on where you are at in the product life cycle phase.
If you are in a early research phase it is not necessary, but your procedures needs to back it up.

If you are in the development phase the purchasing controls have to be in place because you want your product V&V to be valid and representing the final product for release.

During limited or mass production purchasing controls must be in place to insure product quality.

-Shimon
Agree, and it makes sense wrt purchasing controls.

how does the same logic pan out when we talk about design controls!
i.e.,
represent the design control documentation before design-transfer/verification
vs
monitoring/tracking the progress of various aspects of design (inputs - outputs - verification - review - validation)

in short, is it ok to summarize the 'design control components' at a significant milestone, viz., design-transfer/validation stages of product development?
 

shimonv

Trusted Information Resource
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

Sorry... it is not clear to me what you are asking.
Perhaps you can rephrase or someone else could address the question.


Best,
Shimon
 

v9991

Trusted Information Resource
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

:eek:
Sorry... it is not clear to me what you are asking.
Perhaps you can rephrase or someone else could address the question.
Best,
Shimon
:eek:

Sorry for not being not so clear:eek:... thank you for guiding me towards being more explicit and elaborative.

Product development has milestones of poc-pilot-pivotal. each representing respective deliverables and visibility.

On the other hand the 'design controls' include various elements ( plan - inputs - outputs - review - verification - validation )

and the query from my side, is that, at what stage the design elements would be updated/formalized;
  • * is it ok to update those elements before submission batches.(pivotal studies)
  • * is it expectations that, these elements be updated on a periodic and ongoing basis.

once again thank you.

here is another attempt of crisper version of query... ...
is it ok to summarize the development data into design control elements at some milestone VS doing it online as the development progresses!
 
Last edited:

shimonv

Trusted Information Resource
Re: Is the 'compliance' an pre-requisite or is it ok before batch release to market

Hן V9991,
My prospective is that proof-of-concept is like 'playing' in a sand box. It is not necessary to force design controls on these.
As you move forward with the development of a pilot product you ought to have design controls. It will make it much easier to gear up towards pivotal V&V and external tests.

It's okay to update the elements of design controls and related files, but it has to be within the framework of your design and development procedure with its milestones and constranits.

My answer is a bit too general, I think. but I hope you will find it helpful.

Cheers,
Shimon
 
Thread starter Similar threads Forum Replies Date
H Pre compliance test for Glucometer Other Medical Device and Orthopedic Related Topics 1
V Should template/formats be pre configured to claim 21 CFR part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 5
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
J 14001-Looking for some examples of Environmental Aspects and Compliance Obligations/Audits ISO 14001:2015 Specific Discussions 6
F Clause 7.4 Communication Compliance Evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Proving compliance for 5.5 - 5.8 in 62304 IEC 62304 - Medical Device Software Life Cycle Processes 1
D Risk Based Sample Size and Standards Compliance ISO 14971 - Medical Device Risk Management 2
J Maintaining site specific ISO Compliance/Certification within a non-certified organization & centralized processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
I Can the Chief Operating Officer be also the Chief Compliance Officer? Misc. Quality Assurance and Business Systems Related Topics 14
C Product compliance process REACH and RoHS Conversations 10
R UK Compliance monitoring (Auditing) of EASA/CAA Regulations 1321/2014 & 748/2012 EASA and JAA Aviation Standards and Requirements 0
T Aircraft GAPP Software Testing Compliance Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Compliance Manager Dashboard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
T QMS Compliance Department KPIs AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
MaHoDie Regulatory compliance for IVD in india Other Medical Device Regulations World-Wide 2
M On-demand EU MDR Compliance toolkit with online training courses, templates & document management system Training - Internal, External, Online and Distance Learning 0
T Compliance Dept KPI Dashboard AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Regulatory requirements of cloud platform for devices developed in compliance with 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
H Does this clause mean i must be in compliance with AS9100 or is 9001 enough? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
I Where to find MDR compliance device? EU Medical Device Regulations 6
E Compliance with GSPR 10.4 CMR/ED EU Medical Device Regulations 9
G Suggestions for environmental compliance with small machinists? REACH and RoHS Conversations 1
S Training for PRRC (person responsible for regulatory compliance) EU Medical Device Regulations 3
R Evidence of compliance with Directive 2013/59/Euratom EU Medical Device Regulations 3
T Electronic Systems and 8.5.2 compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 3
H Regarding compliance according WEEE Directive CE Marking (Conformité Européene) / CB Scheme 6
M Regulatory compliance ISO 14001 ISO 14001:2015 Specific Discussions 5
S Requirements for ANSI Z540.3 Compliance as End User of Calibrated Instruments AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
M How to build a winning strategy for EU MDR Compliance Book, Video, Blog and Web Site Reviews and Recommendations 0
A Compliance with iso 14155 Other Medical Device Related Standards 1
T Determining FIPS 140-2 compliance in a medical device Medical Information Technology, Medical Software and Health Informatics 2
C Deadline for compliance with added MDR harmonized standards CE Marking (Conformité Européene) / CB Scheme 2
I User ID verification for in-house e-signature compliance Qualification and Validation (including 21 CFR Part 11) 2
Ron Rompen 4.4.1.2 Product Safety Compliance IATF 16949 - Automotive Quality Systems Standard 30
W 6.1.3 Compliance obligations b) - problem with understanding ISO 14001:2015 Specific Discussions 0
S Question: Best alternatives to audits for ensuring compliance Quality Tools, Improvement and Analysis 5
K Compliance Obligations 6.1.3 of ISO 14001 ISO 14001:2015 Specific Discussions 3
Ed Panek Which choice of the following most closely matches the MDR compliance of your company? EU Medical Device Regulations 0
G IEC 60601 Compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Proof QMS compliance for class I ISO 13485:2016 - Medical Device Quality Management Systems 1
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 8
L REACH compliance with MDR EU Medical Device Regulations 4
K ROHs compliance requirement REACH and RoHS Conversations 10
Z Choice of PTC heater voltage to maximize user safety and ease of CE compliance to LVD CE Marking (Conformité Européene) / CB Scheme 0
Z REACH compliance for low volume product REACH and RoHS Conversations 1
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
E Accredited vs. non-accredited labs for 60601 compliance in the US IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E Accredited vs. non-accredited labs for 60601 compliance in the US Other Medical Device Related Standards 4
M Class II type machine , and its compliance with 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 14

Similar threads

Top Bottom