System Boundary Definition
Picture a data centre full of all sorts of other large heavy things with flashing lights and fans blowing. Now qualify it. Where do you start? What is first and what is out of scope? Suddenly this great room of wonder is a daunting cell of despair. We can draw boxes around your systems, qualify your interconnections and help you to sleep at night. Call us today, plan to succeed!!
To GMP or not GMP
Defining System Boundaries is perceived by most as a nightmare of a task? What goes where? Is this our system or their system? Does it need to be qualified? Is it GMP? Picture a data centre full of all sorts of large heavy things with flashing lights and fans blowing. Now qualify it. Where do you start? What is first and what is out of scope? Suddenly this great room of wonder is a daunting cell of despair.
Critical to Validation Success
Defining System Boundaries is critical to the success of any validation effort. Whether you are adding a new network, moving a printer or connecting your latest pH meter to the LAN to communicate with your MES system, questions will be raised as to whether things are in-scope or out-of-scope. Does this belong to the calibrations team or the IT group; do engineering or quality own this? In addition, it is important to work within these boundaries. Consider if you do hook up that pH meter to the LAN, and it is qualified - have you in validated someone elses validation and will that impact the product being released?
We can draw boxes around your systems, qualify your interconnections and help you to sleep at night. Call us today, plan to succeed!!