Overview

QbDVision’s Document Management module provides regulated industries with a centralized and secure repository for comprehensive document lifecycle control, encompassing creation, review, approval, and archiving. This robust solution ensures all your critical documents are managed in one trusted location. Documents you upload here can be approved and sent for training. For more information about how to set up training for your users, click here.

Key features, including version control (tracking every change and ensuring you always have the latest version) and electronic signatures (for legally binding and compliant approvals), are designed to streamline quality management processes. These features help organizations meet strict regulatory requirements like US FDA 21 CFR Part 11 and EudraLex Volume 4 Annex 11.

By fostering real-time collaboration and providing a comprehensive version history, the module enables organizations to enhance efficiency, mitigate risks, and ensure that only approved and up-to-date documentation is used throughout the entire product lifecycle.

Simplified Document Management

Centralized management of all your quality and other important documents.
Streamlined approval and routing processes with compliant electronic signatures.
Native files are easily attached to each approved PDF, ensuring they are readily available for the next revision.
Documents are tagged with relevant regulatory documents and sections for simplified future reporting.

Frequently Asked Questions

Signatures are captured within the metadata that QbDVision controls. Does this add a signature page to each document, or is it simply a report to run?

Individual signature pages (signature manifests) are generated for each document after it is approved.

Documents will be stored on a shared drive; however, does QbDVision support static and dynamic web addresses? I would like to have a link to the most current SOP in our other electronic systems and potentially lock the SOP version in different records.

Our source document widget allows you to link to external references.

I would like, if possible, for all document types to be formatted as follows: three letters, then a hyphen, then a 4-digit running number, i.e., SOP-0001, RPT-0001, TRN-0001, with one exception: FORMS. Can these have the same 4-digit number as the SOP they are associated with, but add a capital letter to the end? E.g., FRM-0001A, FRM-0001B, FRM-0001C. This is a neat way to tie forms to the procedures they are associated with.

The ID field can be whatever you want. We do not limit you to the code or digit length. To set this up, you must set the Custom ID field. Otherwise, we will generate a simple number for you.

Can I have an additional document type for an analytical procedure? Specifically, ATM-0001...?

We do not have a type for this, but you can accomplish this by using the Custom ID field.

Can I have some documents on a 3-year revision schedule, while others are on a 5- or 7-year revision schedule?

We don’t track future revision dates at this time.

Can I choose specific users or groups of users and their view permissions on a per-document basis? In other words, can I choose who can see which documents?

Today, QbDVision permission sets do not go down to that level of granularity, so there is no way to set permissions on a per-document basis. A user can see either all documents or no documents.