http://tech.groups.yahoo.com/group/21cfrpart11/ A forum for issues and questions regardi Tue, 09 Feb 2010 14:36:25 GMT scrod98 http://tech.groups.yahoo.com/group/21cfrpart11/message/19889 http://tech.groups.yahoo.com/group/21cfrpart11/message/19889 While 21CFR820.25b states that training must be documented there is no requirement that it must be signed. What you need to do with your system is provide Tue, 09 Feb 2010 14:36:23 GMT bcooper_psl http://tech.groups.yahoo.com/group/21cfrpart11/message/19888 http://tech.groups.yahoo.com/group/21cfrpart11/message/19888 Based on a quick review of your situation, it sounds to me like you are within the confines of part 11 compliance as far as your training records process is Tue, 09 Feb 2010 14:35:53 GMT Finner, Doug http://tech.groups.yahoo.com/group/21cfrpart11/message/19887 http://tech.groups.yahoo.com/group/21cfrpart11/message/19887 Why do you think you don't comply and what don't you comply with? You must be able to demonstrate that your employees have the necessary skills to do their Mon, 08 Feb 2010 19:06:11 GMT ntl_7colors http://tech.groups.yahoo.com/group/21cfrpart11/message/19886 http://tech.groups.yahoo.com/group/21cfrpart11/message/19886 Hi, Our company is a medical device manufacturing company. We just bought an application to manage training of employees. This application stores training Fri, 29 Jan 2010 16:07:22 GMT Jeremy http://tech.groups.yahoo.com/group/21cfrpart11/message/19885 http://tech.groups.yahoo.com/group/21cfrpart11/message/19885 Thanks to all for the replies. We will look at the options of third party software to provide the required audit trail functionality as one way forward but we Fri, 29 Jan 2010 15:13:55 GMT EdwinK http://tech.groups.yahoo.com/group/21cfrpart11/message/19884 http://tech.groups.yahoo.com/group/21cfrpart11/message/19884 I'm with Doug on this one. First time poster here, but have been viewing the forum for quite a long time and finally have to chime in. I've learned much from Fri, 29 Jan 2010 14:58:31 GMT Jim Validation http://tech.groups.yahoo.com/group/21cfrpart11/message/19883 http://tech.groups.yahoo.com/group/21cfrpart11/message/19883 I do not believe the FDA would go to software vendor X site becasue I am using their software in a GMP environment.  That is ridiculus.  Then one FDA site Fri, 29 Jan 2010 14:58:24 GMT david_howard_3 http://tech.groups.yahoo.com/group/21cfrpart11/message/19882 http://tech.groups.yahoo.com/group/21cfrpart11/message/19882 Jeremy A couple of points on this 1: I've come across similar spreadsheets `controlled' via Document Management Systems for which the audit trail has become Fri, 29 Jan 2010 14:57:36 GMT fpedeconi http://tech.groups.yahoo.com/group/21cfrpart11/message/19881 http://tech.groups.yahoo.com/group/21cfrpart11/message/19881 Hi, wasn't this a forum intended not to be used for commercial purposes or has the policy changed on that aspect? Regards Fri, 29 Jan 2010 14:39:58 GMT fpedeconi http://tech.groups.yahoo.com/group/21cfrpart11/message/19880 http://tech.groups.yahoo.com/group/21cfrpart11/message/19880 possibly the same, Orlando, as without the digital sig capability. Not a bargain anyway being an A**be product, as you may be probably aware of already. Fri, 29 Jan 2010 14:38:41 GMT Orlando Lopez http://tech.groups.yahoo.com/group/21cfrpart11/message/19879 http://tech.groups.yahoo.com/group/21cfrpart11/message/19879 So just because not too many companies are doing this means it is incorrect. For me its means that they are in a state of software QA maturity higher than Thu, 28 Jan 2010 20:34:37 GMT jimvalidation http://tech.groups.yahoo.com/group/21cfrpart11/message/19878 http://tech.groups.yahoo.com/group/21cfrpart11/message/19878 So the companies will call you up during an audit and get validation test data faxed to them? That seems like a risky approach. Just becasue some comapanies Thu, 28 Jan 2010 18:11:53 GMT blewispunk http://tech.groups.yahoo.com/group/21cfrpart11/message/19877 http://tech.groups.yahoo.com/group/21cfrpart11/message/19877 Just my 2 cents on this as our company has a service where we provide electronic data capture and trial management for clinical trials Thu, 28 Jan 2010 16:58:34 GMT 21CFRPart11 http://tech.groups.yahoo.com/group/21cfrpart11/message/19876 http://tech.groups.yahoo.com/group/21cfrpart11/message/19876 Jeremy, It may depend on how protected the sheets are from unauthorized changes and the procedures you have in place to detect changes between versions in the Thu, 28 Jan 2010 16:54:51 GMT Nat Jeffers http://tech.groups.yahoo.com/group/21cfrpart11/message/19875 http://tech.groups.yahoo.com/group/21cfrpart11/message/19875 The licensing costs vary.  It all depends on the approach taken.  It is not very costly on an individual basis but licensing something like the Adobe