In today’s episode, Ericka and her co-host-turned-guest, Philippe Gaudreau, will be discussing different scenarios when using the document control process in Solabs QM 10. Philippe is a Chemical Engineer by trade who founded Solabs almost 20 years ago. Supported by a team of strong developers and IT professionals, Philippe has managed two major iterations of his fully integrated EQMS Solabs QM. Today, the solution is offered via the web and can be hosted in the Cloud or installed on premises. The fully validated and 21 CFR Part 11 compliance solution helps Life Sciences companies automate their quality management system.

 

Ericka and Philippe talk about the document control process and provide listeners with a more indepth look at different scenarios within it. The process is quite unique to Solabs QM and is an extremely useful feature to learn about! Philippe explains what the document control process is, how the creation of a new document works in Solabs QM, the flow of steps within it, how to set up documents for a periodic review, and what’s on the roadmap for upcoming versions of the doc control process

 

Key Takeaways:

[:25] About today’s episode and guest.

[1:35] Ericka welcomes Philippe on to the show.

[1:50] Philippe briefly explains what the document control process is and which scenarios it would be used in.

[3:55] Philippe explains how the flow of steps goes and how the document control process allows to centralize all the requests.

[7:10] How the creation of a new document works in Solabs QM.

[13:18] Can the role of training coordinator be assigned to multiple people in the system?

[14:00] Is training required as part of the creation of a new document? How will the system monitor the training?

[15:36] If you have a document that already exists in the system and you’re creating a new version of that, how would that change within the document control process?

[20:34] How would you set up documents in the doc control process to do a periodic review?

[22:35] Philippe explains a new functionality to be released in version 3 of the doc control process: the ability to use the doc control process to retire a document within Solabs QM.

[24:54] Visit docs.solabs.com to learn more about what Philippe was explaining this episode!

[25:22] What’s on the roadmap for upcoming versions of the doc control process?

[28:17] If you have any feedback for Ericka and Philippe this episode, please contact her at [email protected].

[28:29] About next week’s episode.

 

Mentioned in this Episode:

FDA 21 CFR Part 11

Solabs QM 10

Docs.solabs.com

[email protected]