Get Pi 011-2 Recommendation On Computerised Systems 2004.doc - Jsb-validierung

This guide provides a clear and comprehensive approach to completing the PI 011-2 Recommendation On Computerised Systems 2004.doc form online. Designed for users of varying expertise in digital documentation, it includes detailed, step-by-step instructions for each section of the form.

Follow the steps to successfully fill out the form.

1. Press the ‘Get Form’ button to retrieve the PI 011-2 Recommendation On Computerised Systems 2004.doc document and open it in a suitable editor.
2. Begin by familiarizing yourself with the table of contents provided in the document. This will help you navigate directly to the sections most relevant to your needs.
3. Refer to the 'Purpose' section to understand the objective of the document. This section outlines how the recommendations are beneficial for inspections and compliance in regulated environments.
4. Next, review the 'Scope' section where you will find the applicability of the document's recommendations across various environments, including Good Manufacturing Practice (GMP) contexts.
5. Proceed to 'User Requirement Specifications (URS)' to outline specific functionalities and compliance requirements for the computerized system you are documenting. Ensure each requirement is clear and verifiable.
6. Complete the 'Functional Specifications (FS)' section based on the URS to provide a detailed account of the functional requirements your computerized system must meet.
7. Document any considerations or planned audits for software suppliers in the relevant sections, as this will help maintain a clear record of compliance and risk management.
8. After filling out all relevant sections, ensure that documentation of testing, validation, and any operational protocols is included as per the validation strategies outlined in the document.
9. Once you have completed the form, review all entries for accuracy and completeness. Make sure that all sections are filled according to the guidelines within the document.
10. Finally, save your changes to the document. You can also download, print, or share the form as needed to facilitate compliance checks or further reviews.

Start submitting your documents online to ensure compliance with the recommendations outlined in the PI 011-2 form.