Do we need to Validate Off the Shelf Software?

C

ccurran

#1
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
 
Last edited by a moderator:
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
Re: off the shelf software

If you are going to make decisions based on the software calculations...yes.
assuming you are trying to comply with a standard like ISO.

The "validation" for that kind of canned software can be pretty simple: Put in numbers, see the result...do that same function on paper. They match = you've validated it.

HTH
 

mihzago

Trusted Information Resource
#3
Re: off the shelf software

I typically keep software used by accounting, finance, HR, etc., outside of the scope of the QMS, and do not require that the validation is formally documented.

However, companies always validate their software; I don't know anyone that would purchase a software without checking first if it does what they need, and I recommend they at least summarize the activities performed.
 

howste

Thaumaturge
Trusted Information Resource
#4
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
I see from your profile that you're working with medical devices. Does this mean you need to conform to ISO 13485, 21 CFR Part 820, CMDCAS, European MDD, etc.? More information will help you to get the right answer to your question.
 
#6
I'm writing a purchasing Work Instruction for a small start up. We use Quickbooks for accounting. Does this software need to be validated?
Typically accounting software is outside the scope of QMS certification. However if this software is aiding the organization in inventory management, it should be validated.
 
Thread starter Similar threads Forum Replies Date
S Do we need to validate Software used in Drug discovery and development process? Qualification and Validation (including 21 CFR Part 11) 2
B Do I need to validate my database software? Calibration and Metrology Software and Hardware 1
V Do we need to Validate a Server/Back-End System? Qualification and Validation (including 21 CFR Part 11) 2
T Do I need to validate a basic Excel spreadsheet Quality Assurance and Compliance Software Tools and Solutions 14
V Calibration of a Digital Vernier - Need to check/calibrate/validate all 3 functions? General Measurement Device and Calibration Topics 9
M Digital Filling System - What do I need to Validate Here? Software Quality Assurance 1
N Do we need to Validate Outsouced Processes? ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 12
K Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body? CE Marking (Conformité Européene) / CB Scheme 3
E Need some peer advice Quality Manager and Management Related Issues 18
S Need clarification on UKCA and "Approved Body" UK Medical Device Regulations 7
S What types of changes need to be notified to NBs? Registrars and Notified Bodies 1
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Attempting to Poke Yoke a wire crimping process...need help Design and Development of Products and Processes 3
C I need your help to find the action plan for these quality objectives Misc. Quality Assurance and Business Systems Related Topics 23
C Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
C Need to understand difference between an actual Calibration vs. a Calibration check General Measurement Device and Calibration Topics 3
S How many tester quantity we need on the line based on the cycle time and peak volume Manufacturing and Related Processes 3
R Need help on calibration result analysis Measurement Uncertainty (MU) 17
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
F Need help in IMS management review Management Review Meetings and related Processes 3
S I need help in corrective action plan Nonconformance and Corrective Action 15
A Do clinical performance studies for IVDs need to be conducted in a member state? EU Medical Device Regulations 2
A Do clinical performance studies for IVDs need to be conducted in a member state? CE Marking (Conformité Européene) / CB Scheme 0
D Weird spec sheet - need help Measurement Uncertainty (MU) 3
E Do I need test reports for all standards mentioned in my 510k application? Other Medical Device Related Standards 8
J Japan registration need manual without temperature reading Japan Medical Device Regulations 0
Ashland78 Need IATF 16949 ISO Gap Analysis Excel File Internal Auditing 3
R Need for an Importer outside EU? EU Medical Device Regulations 0
T Do I need to add non-product related service providers to my ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
K Need Help With Auditing Suppliers Against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 50
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
B Need assistance with documents CE Marking (Conformité Européene) / CB Scheme 2
R Lead auditor scenario (Need help) is this non conforming to ISO13485 Manufacturing and Related Processes 2
Ashland78 Need to show evidence in accordance with QR-11012 and SPB-00001-09 Customer and Company Specific Requirements 5
E Does IVD need to integrate with hospital IT infrastructure? Medical Information Technology, Medical Software and Health Informatics 2
U Need Help With API Q2 Quality Manual Oil and Gas Industry Standards and Regulations 8
S In Need of GIDEP Guidance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Do employee training records need to be controlled documents? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D What evidence do I need to supply as a remote location in relation to manufacturing sites? IATF 16949 - Automotive Quality Systems Standard 14
T Non API products need to comply to API Q1? Oil and Gas Industry Standards and Regulations 3
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
MSeibert47 Daily Quality Topics - Need Ideas Please! Food Safety - ISO 22000, HACCP (21 CFR 120) 18
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
D Need some Help on 8D fault tree analysis Problem Solving, Root Cause Fault and Failure Analysis 6
A Need to calculate tolerance Intervals with a set of non-normal data and 3-Parameter Weibull distribution Using Minitab Software 0
Melissa Risk Management Process, How far do I need to go? ISO 14971 - Medical Device Risk Management 13
F Need Quality Manager advice. Quality Manager and Management Related Issues 6

Similar threads

Top Bottom