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Search found 3 matches

by Wiseplastics
Wed Jun 05, 2019 4:32 pm
Forum: Business
Topic: Moving Injection Molding Machines
Replies: 2
Views: 13704

Re: Moving Injection Molding Machines

We have moved a few machines over the years. First is to know or find out what are the customer requirements when moving a machine. Then determine how long it will take to run the studies, measure and submit / wait approval. Meaning you will want to run inventory to cover the down time etc. Even mov...
by Wiseplastics
Wed Jul 18, 2018 6:42 pm
Forum: Business
Topic: Software Validation
Replies: 5
Views: 20016

Re: Software Validation

Thanks to all who have commented. We are going to have some people trained on the topic and attempt the module by module approach based on a risk assessment. It will be painful, expensive and take a long time, but worth it as it exposes issues that one just wouldn't think of. Makes you think twice b...
by Wiseplastics
Mon Jul 16, 2018 1:56 pm
Forum: Business
Topic: Software Validation
Replies: 5
Views: 20016

Software Validation

Wondering what others (who are 13485 registered) are doing in terms of Software Validation. We seem to have a handle on spread sheet validation, but IQMS is a whole other animal. We have received quotes for up to 90k! Any advice? Thank you.