Product-Lifecycle-Management Experience

Gamula

Involved In Discussions
#1
Dear CoveMembers

As the world is going to be more and more digital the topic is becoming really more important: PLM!

My dental company is implementing a PLM software including ERP interface within the next 3 years at 5 sites in different countries. My job is the implementation together with a service provider. Now, I start with QMS for regualtory and quality with first focusing on document management including workflows likfe SOP training, change mgmt, CAPA, nonconformity, and DHF/DMR management in one tool. Afterwards, R&D is coming too.

We are having little less experience with digital workflows and digital documents, therefore, I hope that someone has experience with the PTC software Windchill.

Additionally, we have the MDR knocking on our doors together with the validation of the software.

Is someone out there in the Elsmar universe who has experience and knowledge of Windchill and implementation of this or another PLM?

:bighug:Any feedback is highly appreciated :bighug:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Is someone out there in the Elsmar universe who has experience and knowledge of Windchill and implementation of this or another PLM?
No, I can't say I do.
I have only 2 comments:
1. How can you manage the DHF workflow (other than general documentation) before you'e touched R&D?
2. Your job sounds really scary.
 

Gamula

Involved In Discussions
#3
1. How can you manage the DHF workflow (other than general documentation) before you'e touched R&D?
SAP connection and R&D is in the boat but needs is in phase 2. They mostly use excel or word. When most things are done, SAP is used by the colleagues.
2. Your job sounds really scary.
Without my RA, Q and R&D colleagues it would be more than scary
 

yodon

Staff member
Super Moderator
#4
No specific experience with Windchill but plenty of experience with other systems (and doing validation on them).

If I could give any advice it would be to start minimal and build from there. I've seen numerous companies buy systems, have the providers show them (and implement) all the bells and whistles, and it turns out being unused or despised because it doesn't match the company's workflows / culture. Don't buy into the belief that automation alone is a silver bullet. Define YOUR requirements and how YOU will use the system. Get your users' buy-in, don't ram it down their throats. Work with the users to understand their needs and workflows. Make the tool work for you, not the other way around. (Ok, enough cliches.)

It's interesting to me that there's a belief that MDR is driving software validation. That requirement has been around quite a while (see 13485:2003 7.5.2 & 21 CFR 820.70(i) for example). Granted, there's more focus, but it's not new.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Define YOUR requirements and how YOU will use the system. Get your users' buy-in, don't ram it down their throats. Work with the users to understand their needs and workflows. Make the tool work for you, not the other way around. (Ok, enough cliches.)
These sound like cliches but they're actually very sound advice.
Unfortuantely, it seems that when an org is already locked into a specific product, it's already too late for this (sound) advice. At that stage it IS likely to be rammed down user's throats - at least from what I've seen (eQMS, PDM and CRM implementations, not so much holistic PLM).
 

Gamula

Involved In Discussions
#6
...start minimal and build from there.
Thank you very much and I try this.


Define YOUR requirements and how YOU will use the system. Make the tool work for you, not the other way around.
Nevertheless, it is hard for a change in numerous things simultaneosly. Documents will be digitilized, approval and trainings are tracked in PLM, RA and Q will mostly work with another tools i.e. spirit. I agree and take your advice into account. Beginning from the intended use and stopping in the URS. As soon as the acceptance is there and the tool helpful, not a pain in the ass, colleagues are interested.

It's interesting to me that there's a belief that MDR is driving software validation. That requirement has been around quite a while (see 13485:2003 7.5.2 & 21 CFR 820.70(i) for example). Granted, there's more focus, but it's not new.
MDR isn´t but points out together with your quoted standard & law that anything with humans and trainings needs to be verified and validated. Even processes like CAPA are needing v&v. It is not new but more present.

We also have the topic to face called MDA / MDN / MDS / MDT codes for NB´s. Insted of having anything defined the RA and Q departments are needing to define that, restructure the technical files. Beside the new things to do like PMS, PMCFs.....

To be honest, only some national authorities do better, not perfect, but more efficient than the money greeding notfied bodies like HC and FDA. Thus, I stick to the FDA requirements with eSignatures, Validation (together with IEC 80002 Medical device software - Part 2: Validation of software for medical device quality systems) because they are established. Or is there any new coming up to be taken into account?
 

optomist1

A Sea of Statistics
Trusted Information Resource
#7
a genral word of caution....in many instances the latest iteration of PLM is advertised as the manufacturing environment equivalent of the "Grand Unified Theory" managing expectations is important....
 

Gamula

Involved In Discussions
#8
a genral word of caution....in many instances the latest iteration of PLM is advertised as the manufacturing environment equivalent of the "Grand Unified Theory" managing expectations is important....
Thank you. Would you mind giving me an example?
 

optomist1

A Sea of Statistics
Trusted Information Resource
#9
I wish I could share one...but not at the moment....a little finer point, generally when a new software platform/app are marketed and the associated cost savings to support the business case are presented, the (my experience) "benefits claimed and cost savings" are frequently over stated. Depending on your position in organizational structure, this cautionary note may or may not be of value....Note: I wrote 2-3 responses to the initial post; contemplating whether I should or should not offer my two cents....a Healthy Dose of Critical Thinking is a good thing
 

Gamula

Involved In Discussions
#10
Yes, the cost-benefit topic is always a very important topic and I already appreciate your comments. My job is now project mgmt and was previously RA / Q, therefore, I know what my colleagues need and expect by a) my experience and b) weekly discussions on the software. My biggest concerns are: Bullshit into the system causes bullshit out of the system. And, if the software has to be used ad hoc and the people are not accepting it than the money is completely wasted.

But, the reason for the PLM is the chaos of 5 sites in RA, Q, and R&D. At least, all see the problems of time and money loosing work all have in the in sum 15 departments.

I like your critical thinking a lot! As a biologist I always need questioning everthing: "The important thing is not to stop questioning." from Einstein (take into account that the context of the quote is different!)
 
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