Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-12-13 07:26 UTC (UTC+2h)
 
tarak_desai
Junior

India,
2017-04-06 07:46

Posting: # 17230
Views: 1,181
 

 spreadsheet validation and requirement [Regulatives / Guidelines]

Hello to all,

Can anyone share regulatory guidance on spreadsheet validation?

I have few questions and need guidance on it.

who should do spreadsheet validation? user department or QA ?

what should be role of user department and QA in spreadsheet validation in GCP environment?

what all validation document required?

Do we need to validate dose calculation sheet for clinical study?


Thanks in advance

Tarak
ElMaestro
Hero

Denmark,
2017-04-06 16:47

@ tarak_desai
Posting: # 17231
Views: 994
 

 spreadsheet validation and requirement

Hi tarak,

in the early days of spreadsheets a few issues were identified (e.g. in relation to SD calculation for non.biological data) which caused some people to conclude that all spreadsheets are useless etc.
There are many nuances. Like you I also believe spreadsheets have their place and most of the early issues have been well weeded out, not least because of opensource spreadsheets that had safer calculations.


» who should do spreadsheet validation? user department or QA ?

As per your SOP.
May be your clinical department, your metrology department, IT, or someone else.

» what should be role of user department and QA in spreadsheet validation in GCP environment?
As per your SOP. Usually QA approve plans, reports and do checks.

» what all validation document required?

What di you mean here?

» Do we need to validate dose calculation sheet for clinical study?

Of course not, unless you think the dose somehow is important in relation to safety, efficacy or the subject's well-being.:-D:-D:-D

I could be wrong, but…


Best regards,
ElMaestro

A potentially biased estimator may be a relevant estimator. The case of REML speaks volumes.
Helmut
Hero
Homepage
Vienna, Austria,
2017-04-09 19:32

@ tarak_desai
Posting: # 17234
Views: 907
 

 spreadsheet validation and requirement

Hi Tarak,

» Can anyone share regulatory guidance on spreadsheet validation?

I’m not aware of any one specific for spreadsheets. For computerised systems the EMA’s GCP Inspectors Working Group recommended the guidelines issued by the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Navigate to Publications and have fun with PI 011-3.

» Do we need to validate dose calculation sheet for clinical study?

Sure! Dose is to most important independent parameter in PK. Otherwise you may end up with something like in this case. As an appetizer see Esch et al.* No, it is neither fun nor easy to do.


  • Esch PM, Moor C, Schmid B, Albertini S, Hassler S, Donzé G, Saxer HP. Good Laboratory Practice (GLP) – Guidelines for the Development and Validation of Spreadsheets. Qual Assur J. 2010: 13(3–4); 41–56. doi:10.1002/qaj.466.

[image]Regards,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
vish14184
Regular

India,
2017-04-16 18:56

@ tarak_desai
Posting: # 17242
Views: 747
 

 spreadsheet validation and requirement

Dear tarak,


refer below link of guidance for spreadsheet validation.

https://www.fda.gov/scienceresearch/fieldscience/laboratorymanual/ucm174286.htm#4_5_2

first prepare validation protocol or SOP and define responsibility of validation team (IT, user department and QA), validation strategy depending on risk assessment and it's security. According to SOP/protocol execute validation activities.



With Regards
Vishal Nakrani
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,556 Posts in 3,758 Threads, 1,091 registered users;
31 users online (0 registered, 31 guests).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed