Data Capture under FDA QSR21 CFR 820.70 G

H

horqua

#1
I want to add a serial cable to my Mark10 BG50 Force Gauge and a computer with software (MS Excel) to assist in capturing, charting, analyzing, and trending the data from pouch and tray seal pull tests. Under FDA QSR21 CFR 820.70 subpart G - Production and Process Controls, "When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate the computer software for its intended use according to established protocol".

My questions: Does my using a computer and Excel to capture and chart pull tests meet the FDA requirement? If you believe the answer is yes, can you recommend a source for information to learn how to validate my software and process? Can you offer any insight in how your organization handles this type of situation? :confused:

Thanks! :thanx:
 
Elsmar Forum Sponsor
S

Saenz - 2011

#2
You can use any software for data control. You should have two procedures, one that describes how you control data, and another that describes how you validate Quality System software. To validate excel, you don't need to talk about whether the Microsoft application works.

You need to
1. Name hardware and application version used.
2. Detail how you enter information by going through the actual exercise of entering information and accessing it, and recording the results as pass or fail.

You also should "grade" your databases according to level of risk they present to your quality system if information is lost.


The extent of validation depends on the intended use and its associated risk. The intended use may be reasonably implied for process documentation and actual use.

Class A – No direct effect on product quality or product information. Errors have little safety, business, quality, or regulatory risk. (Examples: Training record database …)

Class B – Moderate effect on product quality or product information. Errors have some safety, business, quality, or regulatory risk. (Examples: Document control system …)

Class C – Direct effect on product quality or product information.
(Examples: Product test software. )

Note: Software such as compilers for product software are Class C. See “Class C?” below for special compiler validation procedures.



It's more than I can discuss here with you, and of course, I can't send you our own procedures. Try this website it might have what you're looking for:

http://www.doxpub.com/

Good Luck!

Diana
 
H

horqua

#3
Diana,
Thank you, thank you, thank you! This is wonderful advice. Very clear and easy to follow. I can do this!
D:thanks:
 
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