FDA Validated System - Workfront??

[SusanBo]

Hi - I put this out there previously and I think I had one person that responded - cannot find that so I am asking again. Does anyone work within the confines of the FDA and their requirements for a validated system in the creation & approval of label art? I am wondering if Workfront & Proof HQ qualifies? We would like to move a portion of our label artwork creation into Workfront for Legal & Regulatory approval. Currently we use LIveLink for the approval workstream and a board review with different entities. We are an PTC regulated company. Thanks in advance for any insight! Susan Bose Susan Bose GOJO Industries

[MatthewBr5]

Hello Susan, My company looked into WF Proofing as a possible product label QA approval tool. In our case, it is for consumer goods such as cosmetics and nutritional products. We found that WF could not be validated to cGMP's for several reasons, but Reason Number One was the god-like abilities of a WF Administrator. Admins have the ability to log in as other people and sign off for them, making it look like that person actually did the signing off themselves. That simply won't fly in a GMP-compliant system that needs a full audit trail. I don't quite recall the details of the other issues any more. WF is project management software, and nothing more -- it's simply not made for Quality Management too. Matthew Brinkerhoff

[JamieHi]

But when you approve as someone the audit text shows it was on behalf of? Jamie Hill JLL EMEA

[JeffTh]

Hello, Our company supports Phase II - IV clinical trials, and plans to validate Workfront as our system of record for documentation. I think the admin concern can be set aside as the system labels those transactions using the 'logged in as' function. Curious to know if anyone else has had experience going through this process, and any potential pitfalls. Our plan is to set the usual validation plan, define and execute test scripts, and summarize findings. We are not a manufacturer, and we must comply with 24CFR Part 11 (Workfront has traceability documentation), cGCP standards, as well as security standards and the new GDPR regs. Thx Jeff Jeffrey Thell Bracket Global

[EXP_-_DustinMa]

Hi Susan, I would recommend reaching out to your Account Executive (AE: sales person) to ask them to submit a request for our latest security docs (SOC report for example) and we can email a copy to you. As for the FDA as a validated system, I can't provide any specifics, but our security team can discuss anything specific to your requirements, or the requirements you need to meet, and your AE can work with our Security team on those concerns. I hope you have a fantastic day! Dustin Martin Assigned Support Engineer Workfront

[SusanBo]

Thank you all for your valuable insights...I will take Dustin's advice and follow up with my AE. Susan Bose Gojo Industries

[JeffTh]

hi Dustin, I have reached out to my AE and have had number of conversations with my contact and Workfront security. While there are some assets such as security summary and Part 11 traceability, I hear crickets when it comes to validation and support for that effort. This is a critical piece for FDA. If there are resources I'm missing, please let me know. I think validation support (validation planning, scenario writing, script execution oversight and summary writing) is a service that Workfront should develop, and would be a great value add for customers. Thanks Jeff ********************************************************************************************************************************** This e-mail message and any attachments contain confidential information. If you are not the intended recipient, you are hereby notified that disclosure, printing, copying, distribution, or the taking of any action in reliance on the contents of this electronic information is strictly prohibited. If you have received this e-mail message in error, please immediately notify the sender by reply message and then delete the electronic message and any attachments. ­­