Which batches should or could be considered for design validation and design verification?

V

v9991

Trusted Information Resource
#1
#1
product development can be considered from various phases viz.,
Prototype - Pilot/scale up - exhibit/submission(pivotal) - commercials

my question is, justification required for considering following
1. prototype / scale up for design verification.
2. submission/.exhibit batches be considered for both verification and validation in sequence.
3. for Design Verification & Validation, can certain parameters/characteristics be split between pilot and pivotal batches.
 
How to manage your QMS while working remotely.
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Inspection for Process Approval - How many batches I should test Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Two batches - Is the subgroup 4 or 2? Statistical Analysis Tools, Techniques and SPC 8
B Traceability of Thermoelement Batches ISO 17025 related Discussions 7
L Why is initial production units, lots, or batches, or their equivalents required for Design Validation? US Food and Drug Administration (FDA) 3
V Batch Chromatography API - Blending of Batches Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
O Establishing SPC for small batches of 10-15 units Statistical Analysis Tools, Techniques and SPC 10
N Final Inspection Retesting for Failed Batches Nonconformance and Corrective Action 6
M Capability Studies in Engineer to Order Small Batches Capability, Accuracy and Stability - Processes, Machines, etc. 5
M Systems for Serial Numbers, Batches and Catalogue Numbers Other Medical Device Related Standards 3
S C of C (Certificate of Compliance) for Production Batches of Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 15
V Common Root Cause for Failures in Scaleup & Commercial (Validation) Batches 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R How many batches have to be kept under Stability Studies Qualification and Validation (including 21 CFR Part 11) 6
Z Help to compare data - 3 groups (15 batches each) collected over 3 consecutive weeks Using Minitab Software 7
D Capability for Small Series and Small Batches Capability, Accuracy and Stability - Processes, Machines, etc. 8
O What Statistical Analysis Technique to use for Batches? Statistical Analysis Tools, Techniques and SPC 6
1 What is a Good Sampling Plan for Small Batches (10-250)? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
T Sterilization Dose Audit - Recommended Quantity of Samples/Batches ISO 13485:2016 - Medical Device Quality Management Systems 1
S Precontrol and Process Capability - CNC Lathes that run small batches - Short Runs Statistical Analysis Tools, Techniques and SPC 12
J How to implement SPC in a CNC m/c shop processing small batches of 'one timer' jobs? Statistical Analysis Tools, Techniques and SPC 9
Marc PPAP Preliminary Capability Studies - Batches - Paint Company APQP and PPAP 3
C PPAP Capability Study - Infrequent batches - Conductor paste APQP and PPAP 6
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 2
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 21
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0
H Statistical Techniques Procedure - What should be included Document Control Systems, Procedures, Forms and Templates 4
Q How should I analyze measurement correlation between me and customer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 12
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 70
N Should it even be on the hazard analysis (software)? FMEA and Control Plans 2
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
Similar threads
Top Bottom