We use cookies to make our websites more user-friendly and to continuously improve them. If you continue to use the website, you consent to the use of cookies. You can find more information in our privacy statement and our cookie guidelines.

Dear Customer

Our Customer Service will be available again as of 2 January 2025. 

Please note that new registrations and requests to be processed manually will only be processed from this point onwards.

You can of course place orders and receive downloads online at any time.

We wish you happy holidays, a peaceful time and a healthy New Year!

Your DIN Media

Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Technical rule [CURRENT]

VDI/VDE 3516 Blatt 2:2013-11

Validation in the GxP area - Small manufacturing and testing devices

German title
Validierung im GxP-Umfeld - Kleine Produktions- und Prüfgeräte
Publication date
2013-11
Original language
German, English
Pages
72

from 155.50 EUR VAT included

from 145.33 EUR VAT excluded

Format and language options

PDF download

  • 155.50 EUR

Shipment (3-5 working days)

  • 172.60 EUR

Monitor with the Standards Ticker

This option is only available after login.
Easily subscribe: Save time and money now!

You can also subscribe to this document - together with other important standards in your industry. This makes your work easier and pays for itself after a short time.

Sparschwein_data
Subscription advantages
Sparschwein Vorteil 1_data

Important standards for your industry, regularly updated

Sparschwein Vorteil 2_data

Much cheaper than buying individually

Sparschwein Vorteil 3_data

Useful functions: Filters, version comparison and more

Suitable online services
Publication date
2013-11
Original language
German, English
Pages
72

Product information on this site:

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

Short description
The scope of this standard is to provide guidance for an adapted and efficient use of FDA 21 CFR Part 11 and to provide guidance on a pragmatic validation approach for small manufacturing and testing devices. Examples of small devices in discussion are, to name only few: pH meters, balances, digital controlled equipment, PLC controlled equipment, electronic recorders, optical sensor instruments and measuring transducers. All of the above examples are inclusive parameters. Medical devices are not within the scope of this standard.
Content
ICS
25.040.40
Also available in
Loading recommended items...
Loading recommended items...
Loading recommended items...