adztesla
Starting to get Involved
Hi all,
I am currently working for a project in medical device industry. As part of adding an additional capacity, we are planning to do an equivalency study with a comparable equipment that is similar to what we currently use.
When inquired,validation group told me to test min and max setting of current equipment to the one that i am going to use. If the min and max works fine for new and comparable then equipment is fine to use.
My question here is if i use min and max setting in the new equipment and get results, will it be okay to compare (equivalency study in minitab) with historical nominal data as i have no min and max data for the current equipment and because of constraints in raw materials i cannot make comparison units in current equipment.
Please advice.
Please note: OQ and PQ in the current equipment is not complete. So i dont need to do a validation study.
Thanks!
I am currently working for a project in medical device industry. As part of adding an additional capacity, we are planning to do an equivalency study with a comparable equipment that is similar to what we currently use.
When inquired,validation group told me to test min and max setting of current equipment to the one that i am going to use. If the min and max works fine for new and comparable then equipment is fine to use.
My question here is if i use min and max setting in the new equipment and get results, will it be okay to compare (equivalency study in minitab) with historical nominal data as i have no min and max data for the current equipment and because of constraints in raw materials i cannot make comparison units in current equipment.
Please advice.
Please note: OQ and PQ in the current equipment is not complete. So i dont need to do a validation study.
Thanks!