tag:blogger.com,1999:blog-85296168360768621342012-02-16T07:45:29.955-08:00CSV SolutionsCSV Solutions specialises in software validation, LIMS, 21 CFR Part 11, documentation, training and database development for the life science sector.
http://www.csvsolutions.ieCSV Solutionshttp://www.blogger.com/profile/03842549452986518990noreply@blogger.comBlogger11100tag:blogger.com,1999:blog-8529616836076862134.post-12354602475120027702011-03-07T02:40:00.000-08:002011-03-15T09:19:33.984-07:00Annex 11<table class="contentpaneopen" style="-webkit-border-horizontal-spacing: 0px; -webkit-border-vertical-spacing: 0px; border-collapse: collapse; color: #333333; font-family: 'Trebuchet MS', 'Lucida Grande', Verdana, Arial, sans-serif; font-size: 13px; line-height: 22px; width: auto !important;"><tbody><tr><td colspan="2" style="line-height: 18px; padding-left: 10px; padding-right: 0px; padding-top: 0px; text-align: left; width: 619px;" valign="top"><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;">The revised Annex 11 Computerised Systems Jan 2011 has been released. Check out <a href="http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf" style="color: #fd8115; outline-color: initial; outline-style: none; outline-width: initial; text-decoration: underline;">Eudralex</a> copy here.</div><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;"><br /></div><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;">The key points of Annex 11 are</div><ul style="list-style-image: initial; list-style-position: initial; list-style-type: none; margin-left: 12px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;"><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;">Has defined requirements for project and operational phase of system.</li><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;">Risk Management</li><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;">Clearly defines that hardware and software components as part of the computerised system.</li><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;">IT infrastructure qualification</li><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;">Electronic Record and Signature requirements</li><li style="background-attachment: initial; background-clip: initial; background-color: initial; background-image: url(http://csvsolutions.ie/templates/cvs/images/bullet.gif); background-origin: initial; background-position: 0px 8px; background-repeat: no-repeat no-repeat; line-height: 2em; padding-left: 20px;"></li></ul><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;">Deadline for coming into operation:<strong style="color: black;"> 30 June 2011</strong></div><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;"><br /></div><div style="line-height: 20px; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; text-align: justify;">If your company needs assistance meeting these requirements please <a href="http://csvsolutions.ie/index.php/contact-us" style="color: #fd8115; outline-color: initial; outline-style: none; outline-width: initial; text-decoration: underline;">contact us</a>.</div></td></tr></tbody></table><div class="blogger-post-footer"><img width='1' height='1' src='https://blogger.googleusercontent.com/tracker/8529616836076862134-1235460247512002770?l=csvsolutions.blogspot.com' alt='' /></div>CSV Solutionshttp://www.blogger.com/profile/03842549452986518990noreply@blogger.com0