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(COMPANY LOGO) CAMP COMPUTERIZED SYSTEM VENDOR AUDIT QUESTIONNAIRE 1. GENERAL COMPANY INFORMATION 1.1 Name Address Years in Business Number of Employees Services Performed or Products Manufactured

How to fill out cgmp computerized system bvendorb

How to Fill Out CGMP Computerized System Vendor Form:

1. Begin by carefully reviewing the vendor form and familiarizing yourself with its sections and requirements.
2. Start with providing your contact information, including your name, job title, organization, and contact details.
3. Proceed to complete the section regarding the specific computerized system you are using or considering purchasing. Include details about the system's name, version, and any other relevant information.
4. Describe the intended use of the computerized system within your organization. Explain how it will be utilized and the purpose it will serve within your operations.
5. Provide details about the system's configuration, such as hardware and software requirements, network specifications, and any other necessary information.
6. If applicable, include information about any additional software or hardware components related to the computerized system.
7. Next, answer any questions or provide information regarding the system's validation status. Indicate whether it has undergone validation testing, and if so, provide details about the validation methodology and results.
8. If the system requires specific security measures, ensure to address them adequately. Explain how the system will be protected from unauthorized access, data breaches, or any potential security risks.
9. If the vendor form includes a section for documenting any risks associated with the computerized system, carefully evaluate and record any potential risks or concerns based on your knowledge and understanding of the system.
10. Finally, review the completed form for accuracy, ensuring that all sections are properly filled out and no information is missing.

Who Needs CGMP Computerized System Vendor:

1. Pharmaceutical companies striving to comply with current Good Manufacturing Practices (cGMP) regulations and guidelines can greatly benefit from utilizing a CGMP computerized system vendor.
2. Biotechnology companies and organizations involved in the development, manufacturing, and distribution of pharmaceutical or biopharmaceutical products also require such systems.
3. Regulatory bodies overseeing the pharmaceutical industry, such as the Food and Drug Administration (FDA), often necessitate the use of CGMP computerized systems to ensure data integrity, quality control, and compliance with regulations.
4. Contract research organizations (CROs) and contract manufacturing organizations (CMOs) working with pharmaceutical and biotech companies may need CGMP computerized system vendors to meet their clients' requirements and ensure data reliability.
5. Any organization that deals with manufacturing pharmaceutical products, managing quality control processes, or handling sensitive data within the pharmaceutical industry may find it necessary to work with a CGMP computerized system vendor.

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