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Protocol Writers offer a reliable and Agency-compliant documents to accelerate your validation program. Our products include with up-to-date knowledge from standards and principles from FDA Guidances to make sure that what out clients 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 each 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.  Just tell us what protocol you need and we'll write it for you. 

 
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Standard Operating Procedures

Commonly overlooked by pharmaceutical industries 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. Talk to us and let us help you sort your SOPs today. 

 
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Requirement Specifications

Design, Functional, and User Specifications are the starting point of any validation life cycle program because it defines the parameters 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. 

 Talk to us and we will write a 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 quality policy can be integrated into your company philosophy. 

We also ensure that the quality policy communicates to the employees that their job affects product quality and therefore, company success. The quality policy will also show your customers your commitment to quality. Talk to us now and we will write your quality policy right away. 

 
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Risk Assessments

Risk Assessments are important because it will determine the scope of your qualification life cycle. We will write your risk assessment considering the impact on patient safety, product quality and data integrity. 

Our risk assessment document will also highlight potential hazards and risk controls. The implementation, verification and assessment of the controls as well as the final risk review will also be covered by our document. Talk to us now, and let's work on your risk assessment program. 

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