Data Management & Communications

The Pharmaceutical Industry's Transition to Electronic Processes

A brief history of the FDA's efforts to persuade pharmaceutical companies to upgrade their outmoded processes, and the advantages of using modern technological tools and software, leaves little doubt that this is where the entire industry is headed. Nevertheless, some (particularly small to mid-sized) pharmaceutical companies are reluctant to transition from their largely paper-based systems to modern electronic solutions. This paper by MasterControl takes a frank look at some valid reasons for their hesitation, and provides a much-needed proposal for getting started.

Integrated Quality Systems Simplify CAPA Management, Mitigate Risk and Maintain a High Level of Compliance

In today's volatile climate of increased regulatory oversight, media scrutiny and widespread recalls, even the hint of a product's failure or a procedural error is enough to damage a company's reputation and negatively impact its bottom line. Life Science companies are especially vulnerable to these risks given the nature of their products and the intense regulatory burdens under which they operate. Failure to meet government and industry regulations can result in punitive events, namely audits, fines, warnings and lawsuits, that adversely affect a company's productivity and ability to conduct business. Special attention has been given to Corrective and Preventive Action (CAPA) violations in recent years. This white paper by Pilgrim Software points out that quality systems must encompass the majority of their company's processes in compliance with CAPA.

Operational Effectiveness: ERP Strategies for Emerging Life Science Companies

Scientific discovery is the fuel that drives the Life Sciences sector, including Biotechnology, Pharmaceutical, Diagnostics and Medical Device companies. Life Science companies must meet enormous challenges as they commercialize new discoveries. Overcoming daunting technical challenges, meeting complex regulatory requirements and managing the multidisciplinary array of skills required to advance a product through development create significant business complexity.

What is the Essence of Quality, Beyond CAPA?

This paper examines and makes the case for going beyond traditional Quality Management systems (CAPA, Complaint Handling, Audit etc) to the essence of quality; the fundamental understanding and control of manufacturing processes.

Manufacturing IQ: Taking Manufacturing Intelligence to the Enterprise

This benchmark report shows that Best-in-Class companies are more likely to implement Enterprise Manufacturing Intelligence to address key market pressures and to achieve efficiencies within their factories and across the supply chain.

NuGenesis SDMS: Improving Data Accessiblity and Intellectual Property Managment

This case study illustrates how the pharmaceutical division of a global healthcare company transitioned to an open access laboratory workflow and improved data and intellectual property management capabilities by implementing Waters Laboratory Informatics solutions, including NuGenesis SDMS, MassLynx, and OpenLynx Application Manager.

Operational Effectiveness: ERP Strategies for Emerging Life Science Companies

Scientific discovery is the fuel that drives the Life Sciences sector, including Biotechnology, Pharmaceutical, Diagnostics and Medical Device companies. Life Science companies must meet enormous challenges as they commercialize new discoveries. Overcoming daunting technical challenges, meeting complex regulatory requirements, and managing the multidisciplinary array of skills required to advance a product through development creates significant business complexity.