Account

You can change the password in the “Account” section, but not the user name.

Document library

CFR – Code of Federal Regulations
CPG – Compliance Policy Guides
FR – Federal Register
GFI – Guidance for Industry

Most abbreviations can be found in the “Acronyms and Abbreviations” (Glossary) section.

The Library of documents in Gate2GMP® does only contain final documents with a few exemptions. There are a couple of FDA-documents where we have chosen to include the draft versions since the FDA has no better relevant source for interpretation of that specific subject and have stated that they will not finalize the guide but will maintain it on their website as a draft for reference.

Document search

You can search with one or more words.
The result will show documents where the search words are present, both as whole words or as a part of a word (e.g. valid will show both valid, validation, validated etc.)
You can not use search operators as dubbel quotes, question marks or asterisks.

The PDF documents are protected from changes and copying but can be printed in high resolution.

Right-click in the text and choose “Search (Simple)” or Ctrl+F. (The word is highlighted in the text and you can scroll forward/back)
For an advanced search, choose “Edit” > “Advanced search” or Shift+Ctrl+F (The result is presented as a list in the left column.)

Warning Letters

No WL:s regarding those paragraphs have been issued since 2006.

Interpretations 21 CFR 210/211 (Premium)

This is a Premium function and you need a subscription. Please sign up here »

If you have a valid subscription, please contact the Key2Compliance® customer service: info@key2compliance.com

– Select a paragraph from the drop-down list.
– A list of the interpretation documents for this paragraph will appear.
– Click on a document link to open the Interpretation summary.
– Click on the “Open PDF” button to open a printable pdf with the summary and an excerpt from the document. The relevant text in the excerpt is marked in yellow.

Glossary

We are always happy to expand the glossary. Please send an e-mail with a suggestion and we will consider if it is suitable to add.

Links

Please send an e-mail with the link name and we will fix it asap.

Events

Please send an e-mail with all the data and we will consider if it is suitable to add.
Note. It must be an event connected to GMP or Quality system knowledge.

Key2Compliance® alumni

If you have attended a public Key2Compliance® course after March 1st, 2014 you should have access. If not, please contact the Key2Compliance® customer service: info@key2compliance.com

Advertising

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Error reporting

We are very greatful for all reports on malfunctions.
Please send an e-mail with a short notice on what is wrong and we will fix it asap.

Learn more about Gate2GMP® in this short video: