Protocol Writers will send you a draft in 24 hours. This game-changing business process is founded on our staff’s efficient teamwork and solid expertise built from working with the biggest biopharma industries. Besides the speedy delivery, we take pride in writing reliable and Agency-compliant drafts. We Write Quality into our documents and here’s how we do it:
1. Identify your requirements.
Our writing process starts by identifying your design, functional, and user requirements. We make sure these requirements are challenged in the test forms. In this data gathering process, we communicate with our clients to identify their design, functional and user requirements once we receive their requests. The documentation of these requirements make up the backbone and limitations of the validation execution, thus, it is of great importance to clearly define them at the start of the process.
2. Discuss scope and test forms.
Based on the requirements identified by our clients, we discuss the scope and applicable test forms for the system to be validated. By identifying the scope of the validation, we advise our clients the most applicable tests for their system, whether they are required or optional to have. Using both the theoretical knowledge from standards and empirical know-how from field experience, we can produce the framework and direction of the validation program after just one call with us.
3. Customize test forms and identify criteria.
Once the scope and tests have been finalized, Protocol Writers starts creating the draft that meets the industry standards, such as ISO, EU, WHO, US Pharmacopeia, and International Pharmacopeia, and regulatory guidelines prescribed by USFDA and European Commission. Our comprehensive repository of test forms allows us to efficiently customize our clients’ protocol and reduce the writing time to mere hours instead of weeks. Along with the expertise of our staff from working with the biggest biopharma companies, we identify the acceptance criteria based on the standards and the system conditions that we collected from our clients.
4. Add insights based on 483s and FDA Warning Letters.
A key step in our 24-hour process here in Protocol Writers is the incorporation of learned lessons from Form 483s and Warning Letters issued by the Agency. Our team has reviewed the Inspection Citations issued by FDA in the past decade here . By doing this, the documents that Protocol Writers create have a better understanding of the rationale of FDA’s enforcement actions and decision making. We aim to make robust and more informed protocols that will avoid and prevent the findings normally observed during inspections.
5. Protocol Writers Internal Quality Review.
Working in this regulated industry, we understand the expense of document generation errors. It can cause grave mistakes, timeline delays, additional costly procedures, corrective actions/preventive actions among others, which no one can afford nor should commit. That is why our drafts undergo scrutiny through an Internal Quality Review to check the accuracy, completeness, compliance to standards and regulatory guidelines, and feasibility. We visualize the test procedures to anticipate execution loopholes and errors that may occur. We write quality into the document to make sure that what our clients receive is a protocol that is reliable, robust, and Agency-compliant.
6. Email the draft within 24 hours.
After the Internal Quality Review, we send the draft via email to our clients for checking within 24 hours after our discussion. No need to wait for weeks to get a protocol that will be satisfactory for approval and compliant to regulations. Just one click of the Send button and the draft will be available in your email, ready for your review.
7. Revise for approval.
If the protocol needs little adjustments after inspection by our client, we implement the comments and revise the protocol. After this, the draft is now ready for the client’s approval. Revisions can also take a long time if not handled right, but with Protocol Writer, this can be reduced significantly so that the validation projects can be completed sooner.