Our Services

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Protocol Writers offers reliable and Agency-compliant documents to accelerate your validation program. Our products include with up-to-date knowledge on standards and FDA Guidances to make sure that what you receive are top-notch quality documents.

 
 
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Validation Protocols

We provide comprehensive protocols containing detailed, concise, and easy-to-execute worksheets for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities. 

We draft validation protocols  covering a wide spectrum of systems, including equipment, utilities, facilities, manufacturing processes, quality control methods, and computer systems.

 
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Standard Operating Procedures

Commonly overlooked by companies as evidenced by 91 FDA citations in 2017 and 1000 citations in the last 10 years, SOPs ensure that processes produce quality that is consistent with your company's standards.

We can assist you in developing standard operating procedures for your equipment, process, maintenance, cleaning, personnel and equipment flows, and more. We can also guide you on drafting the necessary procedures that your company needs as recommended by the Agency. 

 
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Requirement Specifications

A superior Design, Functional, and User Specifications defines a trouble-free validation process because it outlines the requirements to be tested and the corresponding acceptance criteria.  In the view of the FDA, without first establishing end user needs and intended uses, it is virtually impossible to confirm that the system can consistently meet them. 

We write streamlined, bullet-proof requirement specifications to ensure that all of your acceptance criteria will be defined and that the tests executed will be kept to a minimum. 

 
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Quality System Policies

We write quality system policies based on your company's objectives and values. This ensures that your company philosophy is integrated into your quality policy. 

We also ensure that the quality policy communicates to your employees that their job affects product quality and therefore, company success. The quality policy will also show your customers your commitment to quality.

 
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Risk Assessments

Risk assessments are important because they determine risks and hazards potentially associated with your system. We will write your risk assessment considering the impact on patient safety, product quality and data integrity. 

The implementation, verification and assessment of the risk controls as well as the final risk review will also be covered by our document.

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