SBS - The Best Value in QMS software

Is Validation an ongoing process?

Mandy

Involved In Discussions
#1
Our company, which is a developing a Laboratory Developed Test (LDT), has a Master Validation procedure which states: Validation is an ongoing process.

I personally think that validation takes place to prove a process works and that's it, ie once it's done you sign the finished protocol and file in the DHF.

Why would it be ongoing?

Would appreciate some advice from other more experienced Covers.

Thanks
:thanx:
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
What is of importance is to be sensitive to changes that happens in the validated environment, and be able to decide what extent of re-validation and at what time it is necessary to perform and record., so as to assure process stability is maintained .....

In this view some people may term it ongoing.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#3
Somashekar is correct. re-validation is expected after any change. the level of validation is dependent on the failures that might occur due to the change.
 
I

in_cr_ove

#4
What is of importance is to be sensitive to changes that happens in the validated environment, and be able to decide what extent of re-validation and at what time it is necessary to perform and record., so as to assure process stability is maintained .....

In this view some people may term it ongoing.
I agree to your comments & would like to add:
Even a stable process is susceptible to temporal changes, that would need the process to be re-validated to ensure stability & capability. It may be a good idea to have re-validation at pre-decided regular intervals in addition to re-validation due to other known changes.
This may also qualify the statement "validation is an ongoing process".
 

Ajit Basrur

Staff member
Admin
#5
Why would it be ongoing?
Ongoing refers to the entire lifecycle of the process. Once the process is validated, it has to be "maintained in a validated status" and any changes to the validated status need to be evaluated for its impact to validated state.

Hence an "ongoing assurance is gained during routine production that the process remains in a state of control".
 
Thread starter Similar threads Forum Replies Date
N Validation of special processes Oil and Gas Industry Standards and Regulations 0
L Validation without Tolerance Qualification and Validation (including 21 CFR Part 11) 0
shimonv Test Method Validation ISO 13485:2016 - Medical Device Quality Management Systems 10
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Melissa Process Validation of Rotary Heat Sealer Speeds Design and Development of Products and Processes 4
C Validation of process for releasing the UDI EU Medical Device Regulations 4
C Validation of process for production and servicing 5.7.1.5 API Spec Q1, 9th Edition Oil and Gas Industry Standards and Regulations 4
W Transport validation Qualification and Validation (including 21 CFR Part 11) 4
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 6
C 8.3.4 Verification and Validation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
W Transport validation Qualification and Validation (including 21 CFR Part 11) 12
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
P Software verification and validation procedure IEC 62304 - Medical Device Software Life Cycle Processes 6
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 8
C Spreadsheet Validation and Release Qualification and Validation (including 21 CFR Part 11) 2
M Packing Validation & Accelerated Aging Test ISO 13485:2016 - Medical Device Quality Management Systems 2
M Sterile packing validation tests to be performed and protocol Other Medical Device and Orthopedic Related Topics 1
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 1
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
A CNC Mill and Lathe - Validation Manufacturing and Related Processes 2
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 4
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
B Oracle Cloud ERP Validation during Quarterly Patch ISO 13485:2016 - Medical Device Quality Management Systems 1
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
W LTPD, AQL, Ppk and Cpk validation sampling plan table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
J Validation Sample Size for Tray Seal Qualification and Validation (including 21 CFR Part 11) 3
F AS9100 - Validation, FAIR's, ITAR and Sub-Contracting AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R PCBA process validation Qualification and Validation (including 21 CFR Part 11) 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Sterilization validation after changing sterilization process provider Qualification and Validation (including 21 CFR Part 11) 3
B Sterilization Validation Plan Other Medical Device Related Standards 3
D Difference between Test Method Validation and Gage R&R Qualification and Validation (including 21 CFR Part 11) 18
T Laboratory Verification after validation ISO 17025 related Discussions 3
silentmonkey Rationalising the level of effort and depth of software validation based on risk ISO 13485:2016 - Medical Device Quality Management Systems 10
D Questions regarding process validation ISO 13485:2016 - Medical Device Quality Management Systems 10
Y We found out we have been using a equipment without validation for past 4 years Quality Manager and Management Related Issues 6
Z Is IQ necessary for laser marking validation? EU Medical Device Regulations 3
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
A Validation of Forced Aeration Process ISO 13485:2016 - Medical Device Quality Management Systems 3
E Mentor for Test Method Validation (TMV) Design and Development of Products and Processes 2
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
T Annual Validation as a detection mode on a PFMEA? FMEA and Control Plans 5
B TMV - Selection of TM's for Validation ISO 13485:2016 - Medical Device Quality Management Systems 5
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 4
P Human Factors / Usability validation in the time of COVID Human Factors and Ergonomics in Engineering 17

Similar threads

Top Bottom