plantex supports pharmaceutical and health-care companies

In the transformation of complex business-, process- and quality- data into actionable insights. Actionable insights to continuously improve the business

plantex A HOLISTIC APPROACH TO BUSINESS INFORMATION

Digital data convergence, data life cycle management the explosion of business and critical quality data in a complex, stricter regulated environment makes it inevitable for health-care and pharmaceutical companies to implement new applications that enables them to significantly reduce efforts, risks and, ultimately cost.

The Health-care and pharmaceutical industry is generating enormous amounts of data from various internal and external sources, R&D, retailers, patients, CRO’s, CMO’s to name a few. Effectively utilizing these enormous amounts of data and the same time gaining quick and real-time insight into important cross-functional, process and quality information is extremely complex.

In September 2004, the FDA released the guidance document on PAT (Process analytical technology). The initiative is an effort to facilitate the introduction of new manufacturing technologies in the pharmaceutical industry for achieving more efficient processes.

Process Analytical Technology (PAT) is intended to support innovation and efficiency in development, manufacturing and quality assurance through measurement of critical process parameters (CPP) which influence critical quality attributes (CQA). [FDA 2005]

Quality by Design (QbD) A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. [ICH Q8 R2]

DATA SCIENCE, CRITICAL INFORMATION DISCOVERY
DIGITAL DATA CONVERGENCE, VISUAL COMMUNICATION

The quantifiable benefits of QbD and PAT are numerous. Predicted quality, early indication of potential failed batches, cost reduction, operational efficiency (reduction of cycle times), capital expense, improved quality, excellence build into the process and risk mitigation, to name a few. The ultimate objective of QbD and PAT is the real-time release of products through the design and development of processes that can consistently ensure a predefined quality output.

It’s true that the pharma industry is heavily regulated and every change requires a re-validation effort of process and methods that cannot be underestimated.

Traditional business applications are not built to support “holistic approaches to improve processes”. Current business applications (ERP, CRM, SCM, BI, LIMS … ) are built to support daily operations and mainly answers the What Happened and Why questions.

plantex is the answer to the required holistic approach to (business) information.

plantex is built to:

• answer the important What-If, What-next and How questions in addition to What-happened and Why.

• collect, analyze and simulate all the cross-functional critical process parameters and critical quality data.

• transform data into actionable insights. Insights supporting regulatory audits, analyze critical process parameters and its effect on critical quality attributes.

• make certain that your business is running at its full potential.

• create an environment of “real” continuous improvement.

plantex is aimed at collaborative, team oriented, tactical and strategical business and critical quality information discovery, exchange and publication.

Visualization and communication of results is done by state-of-the art real-time collaboration tools. Decision management support is seamlessly integrated using decision boards and snapshots saving all relevant visuals and data.

plantex drastically cuts-back-time necessary to understand and verify the critical process parameters and the effect on critical quality attributes.

plantex A HOLISTIC APPROACH TO BUSINESS INFORMATION

A holistic approach will make certain that your business is running at its full potential, building an environment of “real” continuous improvement as opposed to simply having strong and weak areas.

By leveraging mainstream technology, we are able to achieve an easy and operational non-disruptive implementation.

plantex is built to allow businesses to gradually master data science and … start using existing data to your advantage and make better well-informed and more objective decisions.

Acting on your gut-feeling is good but acting on data is better!

plantex ANSWER WHAT-IF, WHAT-NEXT AND HOW QUESTIONS IN ADDITION TO WHAT-HAPPENED AND WHY.

We provide your business with new perspectives, helping you make well-informed decisions in complex and challenging situations combining problem-solving and decision-making strategies.

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Please contact us for further information, specific questions, or a consultation.

 

Phone: +49 621 595749 0