Generate IQ, OQ & PQ (installation/operational/performance qualification) Report

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
S Flow or Procedure to generate a "Pflichtenheft" Document Control Systems, Procedures, Forms and Templates 1
K Please help me to generate a Production Chart Manufacturing and Related Processes 4
P How to do Nonlinear Regression and generate a Correlation Statistical Analysis Tools, Techniques and SPC 14
C How to Calculate and Generate a Cpk Chart Statistical Analysis Tools, Techniques and SPC 4
B PFMEA Focus - Use of historical data to generate an Occurrence Number FMEA and Control Plans 4
N Validation of CAD Software used to generate our Engineering Drawings? Qualification and Validation (including 21 CFR Part 11) 11
M Wastewater Disposal - Vibratory tumbler systems that generate wastewater Miscellaneous Environmental Standards and EMS Related Discussions 14
J What should generate a CAPA (corrective action - preventive action) US Food and Drug Administration (FDA) 16
S Need assistance on how to generate Change Notices for Vendors and tracking APQP and PPAP 0
H Does a Nonconforming Material Report always generate a Corrective Action? Nonconformance and Corrective Action 9
D Ethical Question - Generate a Corrective Action to force a response and action Philosophy, Gurus, Innovation and Evolution 15
JoCam Rental, service & installation - regulatory requirements EU Medical Device Regulations 2
S Quality management system (Well head installation & maintenance) Quality Management System (QMS) Manuals 5
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Veeva installation and the Loader Tool Document Control Systems, Procedures, Forms and Templates 3
GURU SDI Leak Testing - O-ring installation in the groove of Bore ID Problem Solving, Root Cause Fault and Failure Analysis 4
A Best Method of Auditing an Installation Process at a client job-site ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Do you test the download and installation of a mobile medical device app? Software Quality Assurance 6
Q UDI and Standalone Software - UDI per installation? Other Medical Device Related Standards 6
A What is the definition of Installation that requires Record Keeping vs Set-up 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L Medical Device Installation Records from Third Party Installer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J FDA Microscope IQ (Installation Qualification) Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S ISO 13485 Installation Activities 7.5.1.2.2 ISO 13485:2016 - Medical Device Quality Management Systems 4
G Nonconformity Reporting at Installation Sites Service Industry Specific Topics 8
K Supplier or outsourced? Medical Device installation, sales, training Other ISO and International Standards and European Regulations 7
N Definition of Large-Scale Fixed Installation per the RoHS2 Directive EU Medical Device Regulations 3
E IEC 62304 5.2.2 f - Installation and acceptance of device software IEC 62304 - Medical Device Software Life Cycle Processes 1
S Barcode Scanner IOPQ (Installation/Operational/Performance Qualification) Requirement Qualification and Validation (including 21 CFR Part 11) 9
S Time & Motion Study - Dish TV Installation Quality Tools, Improvement and Analysis 4
J ISO 9001 Audit Questions relating to Installation of Lifts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
T Office Relocation Installation Inspection Sheet Document Control Systems, Procedures, Forms and Templates 5
S ETSO, TSO and EASA Form 1 - Do I need the ETSO approval for the installation? EASA and JAA Aviation Standards and Requirements 3
S SW (Software) - Customer vs. Company Installation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Site Installation Inspection and Testing for a HVAC Contractor Service Industry Specific Topics 2
W Packaging / Heat Sealer Validation - IOQ (Installation/Operational Qualification) Qualification and Validation (including 21 CFR Part 11) 15
A Installation and Validation Procedure for IT Laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Starrett RGC4040-24 CMM User and Installation Manual General Measurement Device and Calibration Topics 2
W IQ, OQ, PQ (installation, operational & performance qualification) compared to PPAP ISO 13485:2016 - Medical Device Quality Management Systems 5
H Basic questions about Installation, Operational & Performance Qualification - PCBA Qualification and Validation (including 21 CFR Part 11) 11
R Is there a Specification for safety wire installation - Aerospace, SAE or otherwise AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
D Tips/Documentation samples required for X-ray Film Processor Installation needed. ISO 13485:2016 - Medical Device Quality Management Systems 1
T Installation Requirements for Bench Top Device ISO 13485:2016 - Medical Device Quality Management Systems 1
MarilynJ6354 Service & Installation Parts Identification - Install equipment at a customer's site Service Industry Specific Topics 6
C Installation Document that meet NFPA 70 & 72 Various Other Specifications, Standards, and related Requirements 3
C NFPA 72 and NFPA 72 Standards - Electrical Installation and Fire Alarm Systems Various Other Specifications, Standards, and related Requirements 3
Q IQ, OQ & PQ (Installation, Operation, and Performance Qualifications) on a CMM ISO 13485:2016 - Medical Device Quality Management Systems 2
C ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification) ISO 13485:2016 - Medical Device Quality Management Systems 30
Q Software installation issues After Work and Weekend Discussion Topics 3
I Medical Gases Installation - Can be classified as MD and ISO 13485 certificated? ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom