Validation Project Plan example

M

maryacton

#1
Hello,

Has anyone got an example of a validation project plan.

It would be great if someone could help me

Thanks
 
Last edited by a moderator:
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#2
Re: Validation Project Plan

Hello,

Has anyone got an example of a validation project plan.

It would be great if someone could help me

Thanks
Hi Mary,

Could you please provide some more info, such as what is being validated - a process, software, computer, etc.? Covers may find it helpful to know what is being validated, as the plans may vary depending on what the subject is. :)

There may also be some documents in the Post Attachments List (the thin green bar in the upper left corner of this screen) which you might find useful.
 
M

maryacton

#3
Re: Validation Project Plan

It is a project plan for the development of a SDLC for a software application.

I'm not sure what to include yet so any advise would be great
 

GStough

Staff member
Super Moderator
#4
Re: Validation Project Plan

It is a project plan for the development of a SDLC for a software application.

I'm not sure what to include yet so any advise would be great
Here is one sample that I found in the Post Attachments List (the thin green bar in the upper left corner of this screen). I'm not sure if it's what you're looking for, but maybe it will give you a starting point.... :)

If you haven't checked it out before, that link (Post Attachments List) is pretty handy and there are tons of documents, plans, etc. that may provide a good start, as well. :)

Example Validation Plan
 
Thread starter Similar threads Forum Replies Date
Q Verification & Validation Project Time Line Qualification and Validation (including 21 CFR Part 11) 5
Y SaMD Verification and Validation SOP and Plan IEC 62304 - Medical Device Software Life Cycle Processes 2
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 0
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) 2
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 6
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
C Template for Excel Validation Reliability Analysis - Predictions, Testing and Standards 6
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 39
D Test summary report example for design validation wanted - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is Validation of Plating Processes required and who is responsible? Qualification and Validation (including 21 CFR Part 11) 11
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
Stoic Manual soldering processes - 100% verifiable, or always requiring validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Rees System Validation Qualification and Validation (including 21 CFR Part 11) 1
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Old medical devices -> 7.3.7. Design and development validation ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom