A Risk-based Approach to Compliant Computerized Systems

ISPE (the International Society for Pharmaceutical Engineering) is the world’s largest non-profit association dedicated to educating and advancing pharmaceutical manufacturing professionals and the pharmaceutical industry. Various GAMP (Good Automated Manufacturing Practice) publications, a trademark of the ISPE, outline how to achieve and maintain excellent quality in the automated systems associated with pharmaceutical manufacturing.  GAMP 5 specifically focuses on a risk-based approach to compliant computerized systems, providing guidance on how to achieve compliant computer programs, while focusing on principles of industry standards such as ICH Q9 and Q10.

A technical document rather than simply a guideline, GAMP 5 highlights a lifecycle, risk-based approach to achieving quality and applies to a variety of information systems, including lab equipment, manufacturing systems, IT infrastructures, outsourced processes, electronic batch recording, patch management and even end-user applications (spreadsheets, databases, etc).

Impact

Relevant to any pharmaceutical manufacturer, GAMP 5 provides practical industry specifications to help achieve computerized systems that are compliant with industry regulations. A high-level evaluation of risk is based on the complexity of the software or hardware system in question. The four categories of software GAMP refers to are: infrastructure software, non-configured software, configured software, and custom software.

Challenge

Due to the extended supply chain and complicated production process of most pharmaceuticals, controlling quality and developing a comprehensive system often requires diligence on a multitude of parts that must be integrated. Different terminology, different risk rankings, and different types of technology can make following GAMP guidelines difficult. Without a consolidated, consistent approach to risk management, ensuring individual computerized systems are compliant can take extensive effort and investment, in both time and money.

The Dyadem Solution

Dyadem helps companies establish an enterprise risk management program and comply with various industry regulations and standards (such as ISO or FDA standards), as well as implement guidance documents like GAMP 5.  Its Stature enterprise software is configurable to allow organizations to follow the risk-based approach that GAMP 5 outlines.  This enables companies to identify, analyze, mitigate and monitor risks across the organization in one integrated system based on the five steps of GAMP 5.  Stature offers an integrated lifecycle model that ensures all parts of the process and product are safe and secure from cradle to grave. With a standardized, comprehensive approach to risk management, Dyadem can help ensure that all relevant information systems meet the defined acceptable practices of GAMP 5, and that risk is properly assessed and monitored according to guidelines.