Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo Especially for content not in the forum
Such as files in the Cove "Members" Directory

Looking for simple Software Validation IQ templates.

C

CQUINT

Registered
#3
#3
indubioush said:
Is it standalone manufacturing software? Usually equipment software is validated alongside doing the IQ and OQ for the equipment.
Click to expand...
I am looking for an equipment related software validation. I developed a document to serve as a guide bu I think I may be missing something and I am looking for benchmarking and improving my version. Do you have a separate checklist for equipment software validation? The one I developed is an IOQ CVS Template to be completed during IQ/OQ process.
 
I

indubioush

Quite Involved in Discussions
#4
#4
If the software is off the shelf and part of the functioning of the equipment, I would include software validation items with the equipment IOQ documentation. If the software is customized by your organization, then the software validation could be a separate document. Here are some items that may be needed in the documentation:
Description of the software (purpose, user, environment, etc.)
Software risk level
Regulatory requirements applicable to the software
Required inputs and outputs for software verification
Method(s) of verification
Validation requirements
Method of validation
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
V ISO 50001 - looking for a generic checklist Various Other Specifications, Standards, and related Requirements 5
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 4
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
A New to QC, looking for resources Problem Solving, Root Cause Fault and Failure Analysis 3
M Looking for a simple procedure on section 7.5.2 for Validation of Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Similar threads
ISO 50001 - looking for a generic checklist
Looking for a EU MDR Gap Analysis template
Looking for a template SOP for UDI implementation for EU Medical Devices
New to QC, looking for resources
Looking for a simple procedure on section 7.5.2 for Validation of Processes
Top Bottom