Title 21 CFR Part 11: Standard Operating Procedures (SOPs) What are they and why are they important?

January 26, 2012 by
Filed under: Compliance, Healthcare, Regulatory 

 

Standard Operating Procedures (SOPs) –

An SOP is a written document or instruction detailing all steps and activities of a process or procedure. ISO 9001 essentially requires the documentation of all procedures used in any manufacturing process that could affect the quality of the product.[1]

To meet regulations, a company needs rock solid SOPs that outline the entire process around the creation, validation, and training of software used in the regulated industry like clinical trial software.

How does this work?  Think of this as a legal framework within a company, and you will understand its purposes and intentions.  you cannot just put the words SOP on something and call it good, you need to understand the system as a whole and then you can follow the procedures to allow

1- Transparency

2– Traceability

3 – Accountability

4 – Lower risk

5 – Increased Quality

6 – Meeting regulatory requirements obeying the law and protecting the public.

To start off the whole process where do we begin:

Step 1: The first step is to create a document log, this is also called “document control” which is a log of all the documents in the system, this allows you to track document names, document versions, ownership, status (active, inactive,etc..), training requirements and effective dates.  The document log is your catalog of documents, you can also use software systems to track this but all that is needed is an excel spreadsheet and your good to go.  Download Excel 2010 Document Log Template Here:

Document Log Document Log

Step 2: The second document needed is an organization chart which outlines the roles and hierarchy of a company.  This is important as this is the foundation of who is in authority and what they do, and this also dictates what they are required to be trained on.

Download Word 2010 Org Chart Template Here:

Example Org Chart Org Chart

Step 3: The third document you create is a document outlining how you do document management, you cannot have SOP system in place without knowing the genesis of your system, this describes the format, layout, and content of your SOP’s along with processes needed to manage the documents.  It is important to note that SOP’s are like “laws” and as such when they are signed by people who have the roles within an organization to enforce the policies, they become effective, however only after people have been training on the documents and the training is documented as well.

I will dive into more in a later post, for now this is the foundation of compliance for a company.

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