Get Form 105.1 R0 Capa Request

Filling out the Form 105.1 R0 CAPA Request online can streamline the process of submitting corrective actions and preventative measures. This guide provides clear instructions to help users complete the form accurately and effectively.

Follow the steps to accurately complete the Form 105.1 R0 CAPA Request.

1. Click the ‘Get Form’ button to access the form and open it in your preferred editor.
2. Enter the issued to or department in the appropriate field. This identifies the individuals or department responsible for handling the CAPA request.
3. Fill in the date when the CAPA request is being made. Ensure the date is accurate to maintain a record of when the request was initiated.
4. Complete the QMS reference field with relevant information that relates to the Quality Management System. This may include a specific number or code associated with the report.
5. Include any other reference numbers that may assist in tracking or identifying the issue being addressed.
6. Assign a unique CAPA ID for easy identification and reference in future documentation and communications.
7. Provide a detailed description of the issue or incident. Be thorough but concise to give reviewers a clear understanding of the problem.
8. Identify the root cause of the issue. This may require analysis to ensure you address the underlying problem effectively.
9. Document the actions taken to correct the issue. This should include immediate measures to resolve the problem.
10. Outline the actions taken to prevent recurrence. This is critical for ensuring the issue does not happen again in the future.
11. Enter the name of the individual who initiated the CAPA request in the 'CAR Initiated by' field.
12. Have the initiator sign and date the request to validate their involvement.
13. In the 'CAR Taken by' section, enter the name of the individual responsible for implementing the corrective action.
14. Obtain the signature and date from the individual who took the corrective action.
15. In the 'CAR Verified/Closed by' section, enter the name of the individual who verified the actions taken and closed the CAPA.
16. Have the verifier sign and date the document to confirm they have reviewed and closed the CAPA request.
17. Once all sections are completed, save your changes, and consider downloading, printing, or sharing the form as necessary.

Complete your Form 105.1 R0 CAPA Request online with confidence!