Apriso's Pharmaceutical Solutions:

Improve Quality, Compliance, Efficiency and Responsiveness

As a Pharmaceutical manufacturer, you are under unrelenting pressure to simultaneously improve manufacturing efficiency, quality and responsiveness while maintaining regulatory compliance. The high cost of compliance, caused in large part by paper-based, disparate legacy systems with manual and labor intensive processes must be streamlined. Of course, the highest quality standards must also be attained. As a manufacturer operating with global production and product supply networks, it is now necessary to more efficiently define and institutionalize systematic production and process control, including trending analysis, in concert with Corrective Action & Preventive Actions (CAPA). Only then can electronic batch records (eBR) substantiate the intent of good manufacturing practices (GMPs) to meet a myriad of global manufacturing regulations. Example regulations include 21 CFR Parts 11, 210/211, 600/620 in the US, Directive 2003/94/EC in the EU, ISO 13485: 2003, among others.

Apriso’s FlexNet helps you to address these complex challenges by providing real-time visibility and control across your operations and extended supply chain network. Leverage Apriso for reduced time to global market and more standardized, consistent business processes to ease regulatory compliance. Apriso’s professional services team and alliance partner network help Pharmaceutical manufacturers to reduce the cost of compliance by replacing paper-based, disparate systems with streamlined processes for improved flexibility, helping you to respond faster to changing market conditions.

The Solution for Today’s Pharmaceutical Manufacturing Industry

Apriso's FlexNet is a manufacturing operations management solution that empowers you to track, trace and control all elements of production and across your product supply network. FlexNet is 21 CFR Part 11 compliant, so can extend the value of your business planning systems by tightly integrating planning with execution. Winning in the Pharmaceutical industry requires partnering with a proven company that leverages industry best practices while supporting process flexibility. Apriso’s solutions enable multiple improvement strategies from a single, global platform.

Deliver Cost-effective Compliance and Enterprise Quality Management

Manage to FDA’s systematic focus on Quality System Inspection Techniques (QSIT)
Enforce GMPs and industry best practices to streamline Quality review cycles
Track and trend operational and Quality data to proactively identify Quality issues and drive Corrective and Preventive Action (CAPA) processes across your extended supply chain
Reduce cost of compliance with centralized process validation capabilities

Accelerate New Product Introductions

Shorten New Product Introduction (NPI) cycle times with concerted global or regional launches
Extend Enterprise Resource Planning (ERP) and Product Lifecycle Management (PLM) systems to reduce time to volume
Accelerate time to global market and best practice process deployment

Improve Operational and Manufacturing Efficiencies

Identify bottlenecks with better visibility into queues
Reduce cycle times and direct labor costs
Improve Overall Equipment Efficiency (OEE) through improved yields and uptime
Reduce raw material and Work In Progress (WIP) “buffers”
Enforce QbD quality testing throughout manufacturing operations; ad hoc capabilities for continuous improvement or troubleshooting

With Apriso, you have the widest possible footprint for management visibility — across your entire enterprise. Performance can be optimized across all aspects of your extended value chain, including people, materials, processes and machines, as well as those of your suppliers. By transferring real-time data, signals, alerts, KPIs and operational intelligence to and from any network location around the world, Apriso empowers manufacturers to respond faster to strategy shifts, changing market conditions and unexpected events.

Some of the Pharmaceutical manufacturers that have chosen to implement an Apriso solution include: