Work Instruction - Document and Record Control.docx

Work Instruction **DRC - SOP Document and Record Control** Purpose ======= This document aims to define the process for the creation, review and approval of documents, as well as changes to documents and how they should be archived. Additionally, this document also defines the processes for creat...

Work Instruction **DRC - SOP Document and Record Control** Purpose ======= This document aims to define the process for the creation, review and approval of documents, as well as changes to documents and how they should be archived. Additionally, this document also defines the processes for creation, review, storage and archiving of records. 2. Scope ===== This work instruction applies to all controlled documents (policies, procedures, work instructions, forms, etc.) and records that are required to support operations, quality management systems (QMS), and legal compliance. 3. Roles and Responsibilities ========================== - Process Owner: Responsible for creating and revising documents. - Reviewer and Approver: Responsible for reviewing and approving the document prior to release. Definitions =========== - Document: Written or electronic information providing instructions or guidance (e.g., SOP, forms). - Record: Completed and filed information that provides evidence of completed activities or decisions (e.g., Management Review, Design and Development Review). 5. Instructions ============ 1. Labelling --------- Name the documents following the schema: ASSOCIATED PROCESS-TYPE-NAME. Name records with device number and device version linked to the associated process from which they are created. Retention Period ---------------- Store QMS documents and records for at least 10 years following their archival date. Store Medical device file for at least 10 years after the end of the device lifecycle. 3. Handling Documents ------------------ 1. ### Creation of Documents Any employee of Symbiotic AI can create a document. Creating a document on Formworks - Login to Formworks - On QMS tab, click on the \ folder. Click on \ and select the option \. A new page will open. Add the title following the section 5.1 of this document. - Add the content of the document. - At the bottom of the page, click on \ to have the content saved. - The document will be saved inside the \ folder. You can move the new document by dragging it to the intended folder. - The new document will be saved as draft. - Login to Formworks - On QMS tab, click on the \ folder. Click on \ and select \. A new page will open. Add the title following the section 5.1 of this document. - Click on \ to select a file from your computer. - Once the document is selected, click on \ at the bottom of the page. - The new document will be saved as draft. 2. ### Edit Document To edit a document: - Open the document - At the top of the page, a message indicates that the document is a draft. Click on \ to open the document. As an alternatively, click on the three dots on the right side of the page, then click on \. The document will open, and you'll be able to edit the document. - Once edits are done, click on \ at the bottom of the page. 3. ### Document Ready for Review When a document is ready to be reviewed: - Open the document - At the top of the page, a message indicates that the document is a draft. Click in \ if the document is ready to be reviewed. - Add your login and password to request the document to be reviewed. - A new page will open. Add relevant comments, if necessary. - Select the role(s) that should review the document. - Click on \. 4. ### Review of Document - To review a document, the respective reviewer(s) and approver(s) will: - Receive an email notifying that a new document is waiting for review - On Formworks dashboard, the reviewer(s) will find a list of documents waiting for review. - Open the document to be reviewed by clicking on it. - A new page will open. At the top of the page a message will indicate that the document is ready for review. Click on the link to start reviewing the document. - Add your login and password to start reviewing the document. - At the top of the page, input the result of the review by selecting \ or \. Add the reason for the decision made or any comment on \ section, if necessary. - Click on \. 5. ### Release of Documents Once document is approved, it is marked as "released", along with the date when it was approved. ### Changes to Documents If a change needs to be made to approved and released documents: - Open the approved document - Click on the three dots at the right side of the page and select \. A screenshot of a computer Description automatically generated A new draft will be created.  Once the changes are done, click on \. A screenshot of a computer Description automatically generated The document will be saved as V2 Draft, indicating that this is the second version of the document approved. To edit or send the draft for review, follow sections 5.3.2 and 5.3.3 respectively.  Both versions, the approved and the new draft, will be available until one of them is archived or discarded. A screenshot of a computer Description automatically generated ### Archiving of Documents To archive documents: - Open the document - Click on the three-dot menu and select \.  - Confirm the request: A screenshot of a computer Description automatically generated - On the original folder, click on \ to access documents archived. - A new page will open with the documents archived.  - Open the document, click on the three-dot menu and select \ if you want to move archived document to its original folder. A screenshot of a computer Description automatically generated 4. Handling Records ---------------- 8. ### Creation of records - On the QMS tab, click on the \ folder. Click on \ and select the option \. A new page will open. Add the title following the section 5.1 of this document.  - Add the content of the document. - At the bottom of the page, click on \ to have the content saved. A screenshot of a computer Description automatically generated - The document will be saved inside the \ folder. - The new record will be saved as draft. 9. ### Review and Release of Records Records don't usually require review to be released. - Open the document - Click on the three-dot menu and select \ if the record needs to be reviewed prior to its release. Select \ when record review is not necessary.  - Add your password to proceed with the release request A screenshot of a computer Description automatically generated - Click on \ if no reviews/approvals are necessary. Add any relevant comment on the comment section.  - Selecting Release With Review: follow the procedures described on section 5.3.3. A screenshot of a computer Description automatically generated - When the record is released, it will present a status of "released", along with the released date.  10. ### Storage of Records Records can be stored on Formwork or on Microsoft SharePoint. 11. ### Change of Records Create a new record in case a significant change is required. Follow section 5.3.6 (Change of Documents). 12. ### Archiving of Records When to archive records: when they become obsolete or new released versions becomes available. The procedure to archive a record is similar to archiving a document, described on section 5.3.7 (Archiving of Document).