The SOP Diagnostic Evaluation

Actionable advice for transforming your Standard Operating Procedure from a slow, deviation-prone regulatory burden to an optimized business process.
Are you a busy QA or operations manager with an SOP on your desk that you
needs work, but don't have time to get into it?
Do you want to make sure that new SOP is clear, concise and easy-to-follow? That it follows best practices and encourages good documentation?
Do you have an SOP that could be simplified, but are hesitant to change the process and risk non-compliance?
Do you have a process that repeatedly creates deviations? How about forms that no-one fills in correctly? Or a team that complains that it's a pain to fill out the forms?
Do you want to reduce the time it takes to review records and data from your SOP?
If you answered yes to any of these questions, then the
SOP Diagnostic
is for you! This systematic and thorough review of your SOP will provide you with a report full of actionable advice for improving your SOP and its forms.

There's no Risk or Obligation to Apply

SOP diagnostic
should be considered the first step before putting any SOP though QA or compliance review. With it, you'll receive actionable advice to:
Make your process easier to follow and document correctly, reducing the number of deviations and compliance issues;
Improve the quality of your procedures and forms, allowing your internal reviewers to focus on their expertise: the technical context and regulatory compliance;
Increase the efficiency of the underlying process, saving you time and money every time the SOP is used.
I'll go through the SOP and its forms with a fine-toothed comb and identify any opportunities for clarifying procedures, applying best practices, improving efficiency and avoiding documentation pitfalls. I'll even throw in some recommendations that could make your whole system work better.

What happens when I click "Apply Now"

When you click the "Apply Now" button you'll be taken to a form where you'll be asked to provide some information including a brief description of the SOP and any process or compliance requirements you have. I'll review the information and respond with any questions, if necessary.
If I'm confident that the
SOP Diagnostic
can help, I'll send you a link to complete payment.
Once payment is processed, I'll perform the review and send you the results within 2 weeks of the payment date.
You'll get a customized, written report specific to that SOP that:
Highlights any issues found with concrete advice for improvement;
Provides advice for simplification, clarification and realizing efficiency gains; and
Suggests recommendations for improvement.

Why put so much emphasis on SOPs?

Whether your product is a pharmaceutical drug, a pre-clinical safety study, a medical device or a recreational cannabis drink, your SOPs are important tools for controlling your product's quality and consistency. They're also how you ensure you're creating the records to prove it.
You train your staff on them, your day-to-day process is governed by them, and they communicate your process to auditors and inspectors.
If your SOPs aren't clear, comprehensive and reflective of current best practice, then you're missing out on the main benefits of having standardized procedures. Depending on your regulatory requirements, you might also be out of compliance.
SOPs and forms that are complex, too confusing or force deviations can cost you time and money in unnecessary paperwork, inefficiencies or worse.
Most facilities will have some form of a QA or compliance review of their SOPs. But there are so many ways to write a compliant SOP! And building SOPs and forms that encourage Data Integrity and Good Documentation Practices is a bit of an art.
That's why I've put together this detailed, systematic peer review from someone who's reviewed hundreds of SOPs in their career. I will identify and recommend things that your compliance review won't or can't catch.

We already have an internal SOP Review Process. Why would we need this?

If you're lucky enough to have someone on hand with both the
to do this kind of in-depth peer review of your SOPs and forms, then that's great! Though it never hurts to have an independent, unbiased review of your critical documents, you probably don't
this service.
But in many facilities, SOPs go for two stages of review: managerial and QA/compliance. The managers are responsible for the technical requirements of their department; and QA reviews it for compliance with internal procedures and regulatory requirements. Then hopefully someone in the chain also reviews it for
everything else
It's the
everything else
that this service aims to help you with:
clarity, simplicity and best practices for writing SOPs;
designing forms that meet ALCOA+ and prompt for good documentation practices;
avoiding common pitfalls, and more.
Most facilities don't have time to spend on evaluating their SOPs in this kind of detail. At least not until something becomes enough of a problem to show up in a CAPA or finding. That's why I've put together this detailed, systematic peer review from someone who's reviewed hundreds of SOPs in their career. I will identify and recommend things that your compliance review won't or can't catch.

100% Satisfaction Guarantee

If you aren't fully satisfied that the report provides you with at least one high value piece of advicethat will improve your SOP and its forms, let me know within 30 days of receiving the report and I will do what I can to make it right, or your money back. Guaranteed.

It's that easy.
For one fixed price you get a detailed report on your procedure with
actionable advice
that will increase quality, compliance and the potential to save you valuable time and money. Satisfaction guaranteed.
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