2 replies to this topic

[sandra_]

Did you ever have to make a decision btwn the two - CloudQMS vs. doc control software? If yes, what option did you pick and what product, as there is an ocean of them on the market, and their Sales is typically so aggressive and disruptive, that supplier assessment alone, far from any implementation, feels like an uphill battle.

[mgourley]

How many documents do you have and how often do they change?

 

I guess that would be my answering your question with a question.

 

I have no clue about Cloud QMS, and I have not used a stand alone document control system (Trace Gains? Share Point?)

 

As little as my documents change, a simple Excel spreadsheet works just fine, because I demand that any changes to documents be requested (documented)  and then approved by me.

 

What are your document control concerns?

 

Marshall

[sandra_]

We average at over 1000 document change orders (DCOs) per year. Add to that the training that needs to be conducted as a result and the amount of work for one doc controller using two spreadsheets becomes staggering at times.

 

Not to mention never really knowing where the hard copy DCO form is at. So getting an e. system to keep track of DCO is a great leap forward. However, once you get there and validate a part 11 compliant software system for your DCO needs, you are literally one small step away form using the same system for all your other QMS controls tracking and maintenance, assuming the system is designed to perform more than just one function.

 

I would like to hear from anyone who's already been through this thought process and see what they landed on as a result and whether they have an advice for someone who's still getting ready to embark on it.