Is Validation an ongoing process?

M

Mandy

Involved In Discussions
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:
 
somashekar

somashekar

Leader
Admin
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

Bev D

Heretical Statistician
Leader
Super Moderator
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

somashekar said:
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.
Click to expand...
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

Ajit Basrur

Leader
Admin
Gazielmd said:
Why would it be ongoing?
Click to expand...

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".
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Packaging Validation Manufacturing and Related Processes 1
adztesla Sterile packaging validation for medical device - ASTMD4332 and ISTA2A ISO 13485:2016 - Medical Device Quality Management Systems 3
K Validation of cleaning, disinfection and sterilization method EU Medical Device Regulations 4
P Process Validation - OQ & PQ Other Medical Device and Orthopedic Related Topics 2
P Validation for blown film extrusion ISO 13485:2016 - Medical Device Quality Management Systems 0
V PQ parameters for computer system validation of configurable software of laboratory equipment Qualification and Validation (including 21 CFR Part 11) 0
M Number of samples for MDSW validation EU Medical Device Regulations 3
C Computerized System Validation in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Testing & Validation Phase Design and Development of Products and Processes 1
M Thread plug gauge validation/certification ASME vs Asian JJF standard Manufacturing and Related Processes 0
G PEMS Validation Plan IEC 62304 - Medical Device Software Life Cycle Processes 4
T What does "fully verify" mean exactly in process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
P Do Barcode scanners need validation in Medical device manufacturing? Manufacturing and Related Processes 6
Mustapha FAI Template Validation ISO 13485:2016 - Medical Device Quality Management Systems 3
A Sample size selection for process validation - continuous data Reliability Analysis - Predictions, Testing and Standards 9
S Need guidance for Software validation Qualification and Validation (including 21 CFR Part 11) 5
M Sterilization Validation - Carryover Medical Device and FDA Regulations and Standards News 3
S Cleaning validation of single-use tips providing treatment of women’s intimate areas Manufacturing and Related Processes 3
T Verification vs. Validation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Confection validation on different batch sizes Qualification and Validation (including 21 CFR Part 11) 0
E Sealing Validation for Medical devices Qualification and Validation (including 21 CFR Part 11) 5
R CNC process validation Manufacturing and Related Processes 1
A Has anyone implemented the Adobe Acrobat Sign Validation Pack to be 21 CFR Part 11 Compliant? ISO 13485:2016 - Medical Device Quality Management Systems 9
C Test Method Validation - ISO Standards Qualification and Validation (including 21 CFR Part 11) 1
J API Q1 - 5.7.1.5 - Validation of Processes for Production and Servicing Oil and Gas Industry Standards and Regulations 4
A Validation Plastic Injection Molding Process protocol ISO 13485:2016 - Medical Device Quality Management Systems 5
M Use of statistical techniques for Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 9
M Risk-based approach to Test Method Validation for Design Verification? US Medical Device Regulations 5
K Design: Verification Vs Validation And Validation Vs Transfer ISO 13485:2016 - Medical Device Quality Management Systems 19
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
A Human Factor Validation Human Factors and Ergonomics in Engineering 4
B Verification and Validation of calculations (FEA) in OCTG components. Oil and Gas Industry Standards and Regulations 9
B Validation of FEA Analyses in Oil&Gas Industries. There are a lot of guidelines for other activities. There is a similar proposal for O&G? Design and Development of Products and Processes 0
K Analytical Method Qualification Vs Validation expectations ISO 13485:2016 - Medical Device Quality Management Systems 1
C. Tejeda Process validation of rework assembly methods (medical devices) Medical Device and FDA Regulations and Standards News 3
B Validation of design for valve api 6d 25 edition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
P Validation for RUO (Research Use Only) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 1
Ed Panek Validation of Signature Software (Off the shelf) US Medical Device Regulations 6
Q Combining Validation Protocol & Report into 1 template Document Control Systems, Procedures, Forms and Templates 4
K ISO 17025 Method Validation and Verification for Test Lab ISO 17025 related Discussions 5
S Environment Monitoring System Validation ISO 14001:2015 Specific Discussions 1
B Supplier Evaluation report - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 3
M Cleaning Validation of components Manufacturing and Related Processes 2
P Validation Methods of Machine learning and Artificial intelligence Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 11
M How to respond to 483 validation finding we disagree with? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 33
I Cryogenic Container Closure Integrity for HCT/P, Validation Method US Food and Drug Administration (FDA) 0
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
G Injection Molded Parts in Verification & Validation Other Medical Device and Orthopedic Related Topics 3
B Spreadsheet - Used for complaint investigation - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 9

Similar threads

Top Bottom