FormWeigh.

Net®
Process Improvement
Modules for Pharma Applications
Implement FDA 21 CFR Part 11

Subject to technical changes, © 09/2010 Mettler-Toledo AG, Printed in Switzerland MT-BASY 30004517
compliance
US FDA has implemented 21 CFR Part 11
on request of the pharmaceutical industry
with the target to simplify drug approval,
specifically to move away from the huge
amount of paper based documents toward
electronic documentation. With 21 CFR
Part 11 the electronic documents become
the originals, while printouts on paper are
non-binding copies. Companies wishing
to comply with 21 CFR Part 11 will have to
implement systems supporting it. One of
them is FormWeigh.Net ®. With the 21 CFR
Part 11 Module a major step towards com-
pliance is achieved.

Automatically adjust the potency

of APIs in the recipe
The optional Active Substances Module
helps you making full use of your API
stock, even if its potency varies from batch
to batch.
This intelligent FormWeigh.Net ® option
automatically calculates the required
amount of material in order to achieve
the required potency in the end product.
FormWeigh.Net ® calculates the new target
weight as well as the new quantity of
compensation material. The result is a
stable product quality even if important
parameters differ from one raw material
batch to the other.
Powerful Solution for the
Pharmaceutical Industry
Designed for compliance
from beginning
Thanks to full batch control in the dispens- FormWeigh.Net® encompasses a full set of possibilities needed
ing and formulation process you gain for successful formulation of pharmaceutical production without
important benefits within your process:
quality problems and in compliance with regulations.
• Full knowledge about the batch status
in every production step
• Traceability over the material flow in Automatic quantity adjustment of active ingredients makes it
the production process
• Assignment of end product batches at the same time to a powerful tool to increase production yield
to used raw materials and realize considerable savings in time and money.