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People often say I should write a book. I doubt if I ever will, but I (in many cases along with my colleagues) have experienced some real interesting audits. I will tell you in advance that all of these tales are true. I will also tell you that any names used (other than mine) have been changed to protect the innocent - yes, some of them really were innocent. I enjoy talking about my audits. I've never been on an audit where I haven't learned something from it. I look at audits as an... Read Full Story

Now that you have created your SOPs, you (QA mostly) must track them and monitor them to verify that they are 1)current and 2) being used as written. A good document tracking software is invaluable for this. If you're in a small company and just starting out, a well designed Microsoft Excel Spreadsheet will suffice for logging and tracking your SOPs. However, as your company grow and the number of procedures developed grows, you will need something like Lotus Notes, Documentum, Trackwise... Read Full Story

Alright. I'm back and we're going to cover the next most important step to getting Standard Operating Procedures up and running at your company or site. Finalizing SOPs can be hazardous to your health. (lol) You can have a nervous breakdown if you don't start off controlling the situation and continue to control the situation. This is where the "REAL QA" comes out in you. The reason is "different opinions". What you have to do is remember that opinions are like eyes - everybody has one...or... Read Full Story

Well, it's been awhile since I updated my blog because I've been pretty busy. I actually had my first date in the past 5 years. He's a wonderful guy and "no" I will not share the tidbits. ( LOL ) Suffice it to say, it was great getting out of the house and doing something other than the internet !!!! My niece, bless her heart, just wants the best for me. She was in hospital with a sickle cell crisis so I cared for her young son while she was hospitalized. Every single intern, doctor... Read Full Story

A great reviving, soul stirring video. This clip doesn't begin to touch on what you will experience if you watch this video. Read Full Story

Before I get started with the next session on Writing SOPs, I want to tell you about a new cyber-friend. I want you to check out http://leadcra.blogspot.com/. Nadia has a wealth of information on her blog discussing the Ins-and Outs of a CRA. Most interesting is the topic on transitioning from Coordinator to CRA. I get a lot of questions about that and even though I've never been a CRA, I attempt to answer it. I think a person with experience can tell you more, so check out her blog. Join as... Read Full Story

At this point, you should have completed Parts 1 and 2 of Writing SOPs . If you haven't, you can find them here. Search my blog. After completing the header, purpose, scope, background , definitions and abbreviations and attachments, you then concentrate on Responsibility and Procedures. The "Responsibility" section should clearly identify what each applicable person should do to maintain the SOP process. It can be in one, 2 or 3 paragraphs - it is your choice how you want to structure. I am... Read Full Story

In our last session, we created the first part of the SOP, which was the header. (See Part 1 if you haven't done that part yet). Today we are going to start on the 2nd major section of the SOP. This section consists of the Purpose, Scope, Background, Defintions and Abbreviations, and applicable Attachments. Under the heading " Purpose ", describe what the SOP is going to do. Hopefully, it will tell the reader the reason they are performing a task and how to do it. The next paragraph in this... Read Full Story

The first thing you want to do when writing a SOP is identify the person who knows the most about the job. For example, if you need an SOP on how to enter data into SAS, then choose this person who actually performs the task to write the SOP. The first think you need is wordprocessing software such as Word, Works or OpenOffice. Your SOP need certain components. I typically start with a header. The header should have the title, version, SOP number and the effective date of the SOP. It should... Read Full Story

I get constant questions about how to write standard operating procedures (SOPs). Therefore, my next couple of posts will be about SOPs. First you have to stop being intimidated when you are asked to write a SOP. Standard Operating Procedures are nothing more than a business plan. No good business would dare function without a good business plan and that is why the FDA and your management expect you to have them. Together, you and I are going to write a SOP. So, to start, I want you to think... Read Full Story