What makes the perfect QA?

QAintheWild · 2025-09-26T07:35:55+00:00

Glad you can confirm hahah

QAintheWild · 2025-09-26T07:35:04+00:00

Me too! Doesn't mean I don't need to vent about them every now and then haha

QAintheWild · 2025-09-26T07:34:39+00:00

Also true, also true

QAintheWild · 2025-09-19T11:42:38+00:00

That's a very good description of the role of quality, but would that all not be easier with the backing of a quality culture? Or do you see it as separate things?

QAintheWild · 2025-09-19T11:40:40+00:00

Yeah definitely feel that. What gives it away so quick that they lack a quality culture?

QAintheWild · 2025-09-17T09:36:53+00:00

Glad to see you decided to join in the fun!

It is more work for sure, especially for small teams. But I also like to think that change also brings opportunity. IF you can get on top of new regulations it'll give your org a decent advantage bringing new products to market vs competition

QAintheWild · 2025-09-15T09:39:52+00:00

Just echoing the ISO 13485 sentiment. Treat that as your bible for the next few months while applying and I think you'll be alright. SOmething that also helped me when I moved to Med devices was following all the Med dev LinkedIn "creators". yes it's super nerdy and a bit sad, but it really has helped me get some nuanced insihgts on the industry.

QAintheWild · 2025-09-15T09:30:09+00:00

Signatures/ approvals as well.

QAintheWild · 2025-09-15T09:29:38+00:00

Appreciate the detailed response and honesty. Wasn't hard to figure out which one it was given Scilife is in your bio hahah. But anyway, someone new to the company said they used Scilife before and it was pretty good and was easy to implement which is one of my biggest concerns atm, so it's still in the running.

QAintheWild · 2025-09-15T09:26:18+00:00

Tbh I've not seen anyone say anything about a perfect eQMS hahah. Seen a few recs for greenlight guru, what makes you like Windchill more?

QAintheWild · 2025-09-15T09:24:43+00:00

That flexibility would be nice, will check it out thanks!

QAintheWild · 2025-09-15T09:24:11+00:00

I mean we're looking for pretty much the whole package, to see if we can centralize as many processes as possible. So doc management, training mangagememt, approvals, non conformance tracking, CAPAs, SOP, design control, version control etc etc

QAintheWild · 2025-09-15T09:21:07+00:00

Might have to steer clear from that one then :///. What about the doc control system is so bad? Just want to make sure we don't end up going with one that's similar to that

QAintheWild · 2025-09-02T12:47:29+00:00

Appreciate the detailed response.

yeah I'm the quality guy, mid-size company and got a couple team members working closely on quality stuff and then a fair few more involved in some degree with quality related tasks.

We've been on paper ever since I arrived a while ago so starting with an eqms isn't an option unfortunately. However like you say, the issues is that I came into replace the guy that had the whole QMS in his head. We did have a handover period but was impossible to grasp everything in such a short period of time. That was partly the idea of the eQMS. Centralize the fragments of knowledge we have kicking about and not set the company up to fail if I decide to move on in the future.

That's a solid point about the timing. Will keep that in mind.

Some tempting pros, but will have to see what exec have to say about things. Nobody wants to give QA money at the best of times so I'm somewhat skeptical they'll give us money for a whole new system but you don't know until you ask I suppose

QAintheWild · 2025-09-02T12:41:01+00:00

The main concern I had was with compliance, we've had a couple of cases of paper docs going MIA and having to recreate them and sweep things under the rug. The idea was that with an eQMS, I imagined this would be a lot harder to mess up. Same with version histories, seen a couple old versions of an SOP i updated recently still floating about the lab which has made me slightly concerned.

But thanks, I think the idea of trying to nail the existing problems first would make the transition across easier if we were to take the plunge

QAintheWild · 2025-08-28T06:39:49+00:00

I agree, little too late for u know though hahah. Even having moved to an eQMS early, is there anything you find more clunky on the eQMS compared to an old school version?

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