Quality Management Systems Documentation

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Questions and Answers

What should you do after editing a document to save your changes?

Click on the save button at the bottom of the page (correct)

Update your login credentials

Close the browser

Delete the document

How can you indicate that a document is ready for review?

By deleting the document

By sending an email notification

By clicking on a designated button at the top of the page (correct)

By saving the document as a PDF

What is the first step for a reviewer when beginning to review a document?

Log out and log back into the system

Open the document from the dashboard (correct)

Print the document for offline review

Send a request to the document owner

What happens to a document once it is approved?

It is marked as 'released' Signup and view all the answers

What is the purpose of adding comments during the review process?

To provide reasoning or feedback for the review decision Signup and view all the answers

What happens if changes need to be made to an approved document?

A new draft is created Signup and view all the answers

What information is required to start reviewing a document?

Your login credentials must be entered Signup and view all the answers

What designation does a document receive after it is modified from its approved state?

V2 Draft Signup and view all the answers

What is the primary purpose of the DRC document?

To outline the creation, review, and archiving processes of documents and records Signup and view all the answers

Who is responsible for reviewing and approving documents before their release?

The Reviewer and Approver Signup and view all the answers

What is the minimum retention period for QMS documents and records after their archival date?

10 years Signup and view all the answers

Which of the following correctly defines a 'Document' as per the DRC?

Written or electronic information providing instructions or guidance Signup and view all the answers

How should documents be named following the DRC guidelines?

Using a schema: ASSOCIATED PROCESS-TYPE-NAME Signup and view all the answers

What type of information does a 'Record' provide?

Evidence of completed activities or decisions Signup and view all the answers

Who can create a document according to the DRC instructions?

Any employee of Symbiotic AI Signup and view all the answers

What should be done after adding content to a document in Formworks?

Save it as a draft Signup and view all the answers

What must you do first to archive a document?

Open the document Signup and view all the answers

Which action should be taken to access archived documents?

Access the original folder and click on the archives option Signup and view all the answers

What happens to the new record after it is created?

It is saved as a draft Signup and view all the answers

When is a review required before the release of a record?

Only if specified in the document creation section Signup and view all the answers

What is indicated by the use of the three-dot menu in document handling?

It allows various document actions Signup and view all the answers

What should you do if no reviews or approvals are necessary for a document release?

Select 'Release without review' Signup and view all the answers

What follows the creation of a record in the specified procedure?

The document is saved in the designated folder Signup and view all the answers

What does the selection of 'Release With Review' entail in the document management process?

It necessitates following specific procedures for review Signup and view all the answers

Study Notes

Purpose and Scope

Defines processes for creating, reviewing, approving, and archiving documents and records.
Applies to all controlled documents, including policies, procedures, work instructions, and forms, essential for operations and compliance with quality management systems (QMS).

Roles and Responsibilities

Process Owner: Creates and revises documents.
Reviewer and Approver: Reviews and approves documents before release.

Definitions

Document: Written/electronic information such as SOPs and forms providing instructions.
Record: Completed information evidencing activities or decisions, e.g., Management Review.

Document Creation and Handling

Labeling: Use schema format ASSOCIATED PROCESS-TYPE-NAME for naming documents; records linked to specific device numbers and versions.
Retention Period: Store QMS documents and records for a minimum of 10 years post-archival. Retain medical device files for at least 10 years after device lifecycle completion.

Document Creation Steps

Employees can create documents via Formworks by logging in and selecting the appropriate folder.
Save newly created documents as drafts, moving them to the intended folder if necessary.

Editing and Review Process

Editing Documents: Open the draft and make necessary changes, then save.
Document Ready for Review: Notify reviewers by clicking the request for review option and adding any relevant comments.

Document Review Procedures

Reviewers are notified via email about documents awaiting review and can access them through the Formworks dashboard.
Review outcomes must be recorded, including reasons for approval or rejection.

Document Release

Approved documents are marked as "released," indicating the approval date.

Changes to Documents

Approved documents that need changes can be opened to create a draft of the updated version, preserving both the older and new version until archival or disposal.

Document Archiving

Archiving involves confirming the request through a three-dot menu in the document view, with access to archived documents via the original folder.

Record Handling

Creation of Records: Similar to document creation, with titles formatted according to established schema.
Review and Release of Records: Records generally do not require review before release unless specified. The release process is straightforward, needing only passwords for confirmation.

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Description

This quiz focuses on the processes for creating, reviewing, and archiving documents within Quality Management Systems (QMS). It covers the roles involved in document management and the definitions of key terms like documents and records. Understanding these procedures is vital for compliance and operational efficiency.