Following on from Daniel's post on the draft EU GMP Annex 11, I'd like to talk about how using the latest version of Q-Pulse can help your organisation check the boxes against some of the new guidance that the draft EU GMP Annex 11 introduces.
What can Q-Pulse do for my organisation?
Q-Pulse
Q-Pulse offers a comprehensive system to manage all of your compliance needs across your entire organisation. Q-Pulse will encourage ownership of your compliance management system, reduce the bureaucracy usually associated with compliance and, crucially, deliver improvement in bottom line performance and the opportunity to advance through your compliance efforts.
Enhanced security
Fortunately, the draft EU GMP Guide Annex 11 guidance is very similar to the 21 CFR Part 11 regulation that deals with the U.S. Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the US. We designed the Part 11 purchasable add-on for Q-Pulse 5.2 to comply with 21 CFR Part 11, as mentioned in our article earlier in the year.
Q-Pulse, with the Part 11 purchasable add-on, includes enhanced security features as options, such as:
Session Timeout - where users are logged out of Q-Pulse after a certain amount of inactivity, for example 15 minutes. The time limit is set by the Q-Pulse system administrator.
Intruder Lockout - if a user gets their password wrong a certain number of times, they become locked out of the system. Only a system administrator can unlock the system to the user. The amount of attempts a user gets is customisable by the system administrator.
Password Rules Enforcement - this concerns the ‘strength' of users' passwords. The stronger the password is, the harder it is to guess. ("Pa$Sw0rd" is stronger than "password"). When password rules enforcement is turned on, Q-Pulse lets you know how strong your password is when you originally set it. The required strength of passwords is set by the system administrator.
Electronic Signatures - an electronic signature means "a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature." In simple terms, a username and password, as used by Q-Pulse, will suffice.
Audit Logger/Viewer - this is a a complete log of all actions taken. Basically, any action that is done on the system is logged. It allows you to view log entries by date and time, user, action, and module and is fully searchable. For example, you could use it to view all non-conformances addressed by a certain user, or to look at all actions done in a certain time frame on a certain date. As an added audit feature, if the log for some reason stops recording, the whole Q-Pulse system is frozen until the problem with the log is sorted. This is to prevent the log from missing any actions and therefore, not recording information that is necessary for audit purposes.
Be prepared
We've been prepared for the extra security that the draft EU GMP Annex 11 guidance would bring in since the release of Q-Pulse version 5.2 last year, which was designed to meet the needs of our customers affected by the FDA's 21 CFR Part 11 regulations.
If you want to get "ahead of the game" and prepare for the proposed changes to EU GMP Annex 11 before it comes into force, Q-Pulse is the Quality Management System for your organisation. If you're a Q-Pulse user on a version older than 5.2, get in touch and upgrade now.
Email us at lifesciences@gaelquality.com or phone us on +44 (0) 1355 593400 and find out how Q-Pulse can improve your organisation and prepare you for the proposed changes in EU GMP Annex 11.