tag:blogger.com,1999:blog-46527335665857239522024-02-08T11:05:07.992-06:00To Validate or Not ValidateAll you ever wanted to know about Validation or at least the hunt for all things validation. Google the internet and you will find a thousand companies and site wanting to SELL you information on Validation and Qualification. This is FREE and merely a forum to post as I learn the ins and outs of Validation for the Biotech Arena.Ben Denhamhttp://www.blogger.com/profile/03294127911370508071noreply@blogger.comBlogger4125tag:blogger.com,1999:blog-4652733566585723952.post-1011131472016181422008-02-10T11:36:00.001-06:002008-02-10T12:21:47.615-06:00Validation Training: ResourcesFor those you in the Validation arena or hoping to join the Validation club, you may have come to the quick realization that there isn't a grand amount of quality training out there. Once you attend a single Computer System Validation class, all the rest seem to be identical material with new instructors and different cities. I guess this repetitive instruction is sufficient if you are truly Ben Denhamhttp://www.blogger.com/profile/03294127911370508071noreply@blogger.com0tag:blogger.com,1999:blog-4652733566585723952.post-62115699126652549782007-10-05T20:40:00.001-05:002007-10-17T16:32:45.242-05:00Equipment Qualification versus Process ValidationConfusion.ISPE's Baseline Guide Commissioning and Qualification clearly states that Equipment Qualification is not the same animal as a Process Validation.I understand that Process Validation covers and verifies the repeatability, accuracy, and precision of a process while Equipment Qualification focuses on an individual piece of equipment.But....Other than the scope of the protocols, they are Ben Denhamhttp://www.blogger.com/profile/03294127911370508071noreply@blogger.com10tag:blogger.com,1999:blog-4652733566585723952.post-13416668175515395062007-09-29T09:24:00.000-05:002007-09-29T10:03:12.244-05:00Vendor Generated Validation Toolkits *This may come across as a blatant rant against incompetency but there are some valuable tips in here if you can wade through to the end.What you can expect from your company's $3000 - $7000 dollar investment:Internal software testing scripts from developers which have headers just slapped on them.Bad scripts that incorporate tribal knowledge only their validation team possesses so it is Ben Denhamhttp://www.blogger.com/profile/03294127911370508071noreply@blogger.com0tag:blogger.com,1999:blog-4652733566585723952.post-9919451569247986412007-09-23T00:44:00.001-05:002007-09-23T00:56:20.165-05:00Tip #1 - User Requirements SpecificationIf you can't test it, don't put it in the URS.*There you go for the first post. A little tidbit of goodness.BDBen Denhamhttp://www.blogger.com/profile/03294127911370508071noreply@blogger.com0