SBS - The Best Value in QMS software

Chosing a procedure title - "Validation of equipment" or "Qualification of equipment"

Mandy

Involved In Discussions
#1
Should I title the procedure that deals with IQ, OQ, PQ "Validation of equipment" or "Qualification of equipment"?

Thanks,
Mandy
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: "Validation of equipment" or "Qualification of equipment"

Hi Mandy ...
The world calls it as Validation of process.
This needs an approval of equipment.
.
..
So Validation of xxx process
approval of equipment = IQ
 

Mandy

Involved In Discussions
#3
Re: "Validation of equipment" or "Qualification of equipment"

Just to clarify: you are saying a process undergoes validation, but equipment undergoes approval or qualification?
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Re: "Validation of equipment" or "Qualification of equipment"

Its all validation

despite the use of the word 'qualification' in IQ, OQ, PQ...it's all validation
 

Ajit Basrur

Staff member
Admin
#5
Re: "Validation of equipment" or "Qualification of equipment"

Just to clarify: you are saying a process undergoes validation, but equipment undergoes approval or qualification?
Qualification is a subset of validation.

As per the EU GMP guidelines, Qualification is applied to material objects e.g. equipment, utility systems, hardware etc. while Validation is applied to non-material objects like processes (manufacturing, cleaning etc.), procedures (analytical methods + sampling), software etc.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#6
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

ISO 13485 also requires validation of the medical device itself.
 
#8
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

In agreement with the statements of those above, and fyi the title of our procedure when working for an ISO 13485-certified contract manufacturer was "Qualification of Equipment, and Validation of Processes and Software"
 
#9
Re: Chosing a procedure title - "Validation of equipment" or "Qualification of equipm

Should I title the procedure that deals with IQ, OQ, PQ "Validation of equipment" or "Qualification of equipment"?

Thanks,
Mandy
You are qualifying each step of the process (IQ, OQ, PQ) to enable you to validate it.

Your process validation documentation will show that you can operate a process within established parameters and can effectively reproduce results to specifications and quality requirements.

You can call it whatever you like, but for clarity and global marketability, the title 'Validation of XXX' is the most viable in every language
 
Thread starter Similar threads Forum Replies Date
H Chosing a Six Sigma Green Belt Project - Software Industry Six Sigma 9
B Process / Procedure - Radiographic (X-Ray) Non-Film Document Control Systems, Procedures, Forms and Templates 0
M Procedure for vigilance system according to new MDR EU Medical Device Regulations 0
M Procedure for clinical evaluation according to new MDR EU Medical Device Regulations 1
S Production Work Order Procedure 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E System&Procedure pack or accessory EU Medical Device Regulations 0
K Contract Manufacturer Do they need a complaint procedure? Medical Device and FDA Regulations and Standards News 8
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 0
B Procedure facility license in karnataka Manufacturing and Related Processes 3
S MDR - System and procedure pack article 22 and all sub processes that apply ISO 13485:2016 - Medical Device Quality Management Systems 0
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
B Procedure packs with non-medical devices EU Medical Device Regulations 1
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Example of a defined procedure for carrying out Material Review Board (MRB) Manufacturing and Related Processes 0
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
S Critical characteristic on manufacturing operations test procedure Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
A SPC procedure / flow chart Statistical Analysis Tools, Techniques and SPC 2
J Action Not defined in procedure - NC - Incoming inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Procedure ( SOP) for Device Master Record ( DMR ) and for Device History Record (DHR)? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
U Procedure pack components EU Medical Device Regulations 3
G Control Plan & PFMEA Review Procedure? FMEA and Control Plans 8
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
A IVD in MDR procedure pack EU Medical Device Regulations 2
G RoHS Procedure REACH and RoHS Conversations 2
John Predmore Configuration Management as a process instead of a procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 6
W Using tailoring guidelines to tailor a QMS procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
L Sample Procedure from Contract Manufacturer Prospective ISO 14971 - Medical Device Risk Management 1
T Internal Nonconformance procedure thoughts (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
DuncanGibbons Resources for aiding in procedure, work instruction and manufacturing plan development and management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
N EU MDR - Applicability Article 22 Systems and Procedure Packs CE Marking (Conformité Européene) / CB Scheme 4
M Example of statement for procedure pack MDR Article 22? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
R Procedure, Frequency and Acceptance Criteria for Replicate, Recalibration, Before-After and Intermediate Checks ISO 17025 related Discussions 8
B FDA-Medical Device Reporting (MDR )procedure compliant with 21CFR section 803 US Food and Drug Administration (FDA) 0
M MDR - Is a formal GSPR Procedure required? EU Medical Device Regulations 21
Moncia Production Planning procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
L Purchasing procedure and workload ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
J Roles and accountabilities procedure? ISO 13485:2016 - Medical Device Quality Management Systems 9
K Procedure equals a process? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 25
M EU MDR - RA procedure for EU EU Medical Device Regulations 5
F Procedure for Device End of Life/Obsolescence Other Medical Device and Orthopedic Related Topics 3
A MAH license transfer (medical device registrant) procedure in Indonesia Other US Medical Device Regulations 0

Similar threads

Top Bottom