Are you struggling with keeping your Fiber Optic Dissolution data compliant?
Are you spending too much resource time ensuring the chain of custody of your QC samples?
Does your environment demand 21CFR part 11 capable software?transmembrane FLUX.
DissoPRO™ brings Pion’s fiber optic users the ability to develop and run dissolution methods in a compliant software package.
How will DissoPRO help me?
Addressing the needs of today’s dissolution scientists, DissoPRO™ is a powerful and secure yet user friendly, 21CFR Part 11 compliant package developed in response to the demands of dissolution experts like you.
Some of the advantages of using DissoPRO are:
Incorporation of a full audit trail
The digitally signed raw data is stored in a secure location, and ALL user actions are logged and can be reviewed and audited.
Easy definition of roles for role-based security
4 tiers of functionality are natively defined: Administrator, Developer, Analyst and auditor. Only Developer or above may create or edit experiments
Native exploitation of AuPRO capabilities
If you have developed a method in AuPRO is can easily be transferred into DissoPro, or you can easily create a new method.
For example, you are able to use our industry-standard ZIM method for simultaneously monitoring 2 differently absorbing components in one experiment
Reference and Blank Channel Designation
Accounts for changes in molar absorption related to peak shifting, media change, or any other chemical change in a drug substance
Streamlining your workflow
Effortlessly save and transfer fiber optic methods from your development lab to your QC/Compliant lab