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, QPu... 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 lik... 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 inter... 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... 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 stru... 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 paragr... 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 thin... Read Full Story
Happy New Year Everyone!As 2009 opens, we embrace a year of change and it could not have come at a better time. The economy is a state I would never have expected in my life time. Many colleagues are employed and either can not find work or cannot find work in an environment that will make them happy. Most of America's management continue to have the micro-management mentality where they must see you in the "central" office because they can't monitor your comings and goings... Read Full Story
