{"id":24095,"date":"2016-07-25T10:15:37","date_gmt":"2016-07-25T08:15:37","guid":{"rendered":"http:\/\/help.qualiware.it\/qw-help\/?p=24095&lang=en"},"modified":"2018-04-17T11:41:47","modified_gmt":"2018-04-17T09:41:47","slug":"gmp-index","status":"publish","type":"post","link":"https:\/\/help.qualiware.it\/qw-help\/gmp-index\/?lang=en","title":{"rendered":"QualiWare configuration for use in accordance with GAMP guidelines"},"content":{"rendered":"

To be compliant the requirements of the GAMP guidelines (EU GMP Annex 11), Qualiware recently planned to make some changes in its platform.<\/span><\/p>\n

Definition of system administrators<\/h3>\n

In accordance with the requirements of p.to 2 of EU GMP Annex 11 (Personnel), it is necessary to identify a restricted number of people who are experts in “Information Systems”<\/strong><\/span> to which is assigned the role of “System Administrator.”
\nThese people will be the unique, in addition to the staff of Analysis, able to make changes to the system configuration, such as the ‘ attribution of abilitazion<\/em> or the creation of documentary categories<\/em> .<\/p>\n

Choice of access and password policy<\/h3>\n

To allow the use of strong electronic signature<\/a><\/strong><\/span> (ref. Ref. 21 CFR Part 11 pts 11:50, 11.70 and 11.200 \/ EU GMP Annex 11 p.to 14),
\nif you choose to use “password managed by QualiWare <\/strong><\/span>“, you must set the described below:<\/p>\n

– Access by Windows login
\n– Allow the access to only users with defined password
\n– Request strong password (at least 8 characters, containing at least one uppercase letter, one lowercase and one number)
\n– Set password expiration days ( Recommended 60 days or less).<\/p>\n

\"gmpGestione-permessi-sulla-scheda1_en\"<\/p>\n

Alternatively you can use the “password managed by LDAP” <\/span><\/strong>(read here<\/a>), connected to the company domain, provided on the latter have been set criteria on equivalent passwords to those reported above.<\/p>\n

You should also read the following articles, to get some more information about it:<\/p>\n