Health and Life Sciences

DECIMAL’s expertise and technological solutions are a perfect fit for the challenges facing the health and life sciences sector. Now more than ever, pharmaceutical labs and biotech and medical supply companies need to implement innovative solutions to help them perform their tactical and strategic activities related to quality, risk, governance, incident, and cost management.

Whether these businesses need to acquire a better understanding of the next decade’s major issues through cost-management, profitability or budgeting aids, use effective, innovative and flexible tools to ensure stricter compliance with ever-greater regulatory constraints, optimize internal audits or simply manage risk, DECIMAL’s expertise and technological solutions constitute an invaluable resource to many companies in this sector.
Life sciences companies face many unique challenges.  In an age of enhanced consumer awareness and FDA initiatives surrounding pharmaceutical quality, it is critical that companies focus on product quality throughout the product lifecycle to reduce operational and reputational impacts and costly product recalls.  In addition, regulatory, revenue, channel and competitive pressures make it increasingly more important for these companies to foster quality resources for profitable growth.

In August, 2002, the U.S. Food and Drug Administration (FDA) launched the first major overhaul of pharmaceutical current Good Manufacturing Practices (cGMPs) in a quarter-century. The new directive, entitled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach”, outlined the agency’s vision for a new approach to manufacturing and compliance based on risk analysis, improved process understanding and quality system methodologies.  It encourages modern approaches to manufacturing, monitoring, and control to enhance process predictability and efficiency. Although the introduction of another key initiative, Process Analytical Technology (PAT), takes a different approach to quality assurance (process controls and in-process data versus single laboratory determinations to make batch acceptability decisions), the focus of the FDA initiatives continue to remain on enhancing product quality.

Life sciences firms are bound by regulatory requirements such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs), as well as 21 CFR Part 11 from the FDA and the Sarbanes-Oxley Act of 2002.   In addition, life science companies are subject to various health & safety and environmental regulations.   Over the last several decades, companies managed their quality, health & safety, and environmental, financial and other compliance requirements through traditional hardcopy means or via a collection of disparate systems (point solutions).   Even with the deployment of globalized ERP solutions, the specific compliance areas are still often managed in silos, divided along organizational or domain lines.  In addition, the management of risk and corporate governance within organizations have often been managed separately from the traditional compliance areas.  Without a comprehensive , integrated, and strategic approach to quality and compliance, financial impacts can be compounded due to inefficient processes, lack of collaboration, and incomplete compliance indicators.

Achieving sustained compliance with current regulations means that companies must have the agility within their compliance systems infrastructure to change processes as their organizations and regulations change.  

Whether it’s a question of financial, operational or internal audit performance, DECIMAL is your first-choice partner for improved performance!

Our solutions enable you to do the following:

Optimize your financial performance

•  Activity-based costing and management 
•  Profitability optimization
•  Budgeting process
•  Cost management

Optimize controls, compliance implementation and risk management

•  Internal audit
•  Financial compliance
•  Risk management
•  IT governance