Login (User Login; top right of page) with your web user or complete this form to download.
Innovation, Regulation (FDA 21 CFR part 11) and the ‘patent cliff’
A wind of change is blowing through the pharmaceutical industry. An industry which has been characterized by heavy regulation and patent protection is about to change.
Over the next five years branded drugs with a value of ‘about $255 billion in global annual sales are set to go off patent'1. This means that there will be a lot of pressure to become more efficient and competitive. This is where the powerful SCADA system zenon steps in.
Some important facts about the pharmaceutical industry
- until now the pharmaceutical industry has been very profitable thanks to patent protected drugs
- the pharmaceutical industry is considered the least efficient of major industries
- the market share of generic drugs will rise from 75% to 85% by 20152
- lapsing patents will force the pharmaceutical industry to become more competitive
SCADA and FDA 21 CFR part 11
What is the solution to all the challenges ahead? Becoming more efficient while still complying with regulation and guaranteeing product safety! A powerful SCADA system, like zenon from COPA-DATA, can help you do so.
How can the SCADA system zenon contribute to enhance your production?
- natively ready for creating FDA 21 CFR part 11 compliant SCADA projects with minimum engineering effort
- increase output and optimize your KPIs
- optimize yield and minimize the consumption of raw materials
- powerful audit trail and batch control
- integration of all relevant data necessary to optimize processes
- implement lean manufacturing and six sigma
Of course, there’s a lot more zenon has to offer.
Download our White Paper now to learn more about the industry’s challenges and how to cope with them.
* industry leaders like BMW, Audi and PEPSI Cola have been using zenon for many years to increase their operational excellence.
1 in the US market; Source: EvaluatePharma Ltd
2 in the US market; Source: Institute of Mathematical Statistics