Released Documents View - New Feature Coming Soon!
Let's be frank.
Documentation plays a crucial role in your QMS.
The efficiency of your medical device company relies on your ability to manage and control the technical documentation.
These documents, being required by ISO 13485 and FDA QSR 820, must be correct, complete, and consistent.
To achieve this, solid document control is required.
However, systems and procedures that do not support efficient and streamlined document control can make the work overwhelming. When scrambling to get the Technical File ready for release, a stream of documentation activities occurs in parallel, with multiple updates and releases taking place frequently and simultaneously.
Released documents - up front
Attaining an overview of the currently approved, released state of all documents can be challenging and failing to do so, resulting in sending, or operating on, an outdated document version, can have significant effects.
For this reason, we announce the new "Released Documents" view, providing an unambiguous overview of the currently released documents in a single place. The documents displayed are your published, approved, and effective documents, in-short, your single source of (document-) truth.
Your team gets swift and exact access to the currently approved documents, appreciated during hectic audits and when scrambling to finalizing a submission. From now on, released documents are easily distinguishable from drafts, obsolete or superseded versions.
Powerful and flexible document management
The released state of your documents can be established with or without Aligned Elements built-in 21 CFR Part 11 compatible electronic signatures. Thus, you can decide yourself what makes a document being "released" in your Aligned Elements setup.
The released documents are organized and displayed in their corresponding file chapters for easier orientation. Additionally, visual indicators highlight documents where a new version is currently being drafted.
Filtering, searching, and sorting can be done using Aligned Elements standard mechanisms. In addition, Aligned Elements Tags can be applied to achieve quick filtering and grouping for selected purposes, such as all documents applicable to a standard or a geographical market.
Bulk operations such as download, analysis and report generation are available per default. Read-access to the "Released Documents" view is available to all users per default but can be displayed selectively by assigning the appropriate user permissions.
Edit Documents View - the broader and deeper access
The Released Documents view is the go-to place when looking for the currently approved and released version of a document.
However, for getting a broader and deeper view of the current work state, the "Edit Documents" view provides the tools you need. This view displays all documents in their live state, including unreleased documents in draft and ongoing updates of already released documents.
Conclusion
To provide a straight-forward and yet flexible Document overview that matches your organizations needs, this feature strengthens, streamline, and promote good document control practice in your Aligned Elements projects.
By integrating this new feature, you will achieve:
- Direct and unambiguous entryway to released documents
- Protection of documents from unauthorized access
- Better and faster support for compliance activities
- Improved document security
The Released Document view is available in the Web Client of our upcoming Aligned Elements v3.0.
