SOP Writing

FDA regulations and electronic records compliance requires that the organization has formal documentation describing their business, quality and compliance practices. Different organizations have different nomenclature or ways of organizing this documentation, but in general, there are three main classes of procedural documentation:

• Policies are high level statements of the goals and general methods of an organization
• Procedures (often called Standard Operating Procedures or SOPs) are more specific instructions on how specific tasks will be performed
• Work Instructions are more specific instructions on how to perform specific tasks

21 CFR 11 requires organizations have numerous policies, procedures and work instructions, including:

• Computer Validation (required by 21 CFR 11.10(a))
• System Backup and Recovery (required by 21 CFR 11.10(c))
• Data Archiving (required by 21 CFR 11.10(c))
• Business Continuity (sometimes called Disaster Recovery) (required by 21 CFR 11.10(c))
• Granting System Access and Computer System Security (required by 21 CFR 11.10(d), .100, .200, .300)
• Training and Training Documentation (required by 21 CFR 11.10(i))
• Use of Electronic Signatures (required by 21 CFR 11.10(j))
• Document Control (required by 21 CFR 11.10(k))
• System Operation and Maintenance (required by 21 CFR 11.10(k)(1))

Ofni Systems has written policies, procedures and work instructions for numerous FDA regulated organizations, including biological products manufacturers, clinical research organizations and software manufacturers. We know that different organizations (and different sized organizations) need different types of SOPs and will create SOPs that match your exact business needs.

Creating Procedures to Match Your Business

Ofni Systems knows that the hardest part of creating a useful SOP is balancing the responsibilities that different groups will have to accept from the new procedure. One of the key parts of our process is that Ofni Systems will bring the critical people together and facilitate a discussion on creating a workable process that meets the appropriate regulations. We can offer workable solutions that will balance the different needs within your organization for workability and compliance. This discussion will ensure that management understands why they have the practices they do so they can effectively train and enforce the new procedures.

More Than Just a SOP Template

Anyone can sell you an “SOP Template” that has a stripped down regurgitation of the regulation with you filling in your company name at the top. The issue is that when you use these templates, what you have is a procedure that is too general to be useful. Your employees don’t know what to do or why they need to do it. Since your employees can’t follow the new procedure, your organization is now at more regulatory risk than before. The Ofni Systems process will provide SOPs that your group understands and can follow to ensure regulatory compliance.