Compliant Cloud Computing – Managing the Risks
by David Stokes
This article presents pharmaceutical business process owners with an explanation of what cloud computing is, how it differs from traditional Information Technology (IT) outsourcing, and how the specific risks associated with cloud computing’s essential characteristics can be understood, assessed, and mitigated.

Has MES Reached Maturity in the Pharmaceutical Industry?
by Desmond Savage
This article presents the findings of a study that demonstrates MES is being adopted by the pharmaceutical industry.

A Leaner Software System Development Process
by James E. H. Stafford, PhD
This article presents new insights into software design, including a more efficient way to implement software without undermining regulatory expectations.

An Introduction to the ISPE IP COP Survey on Patient Experience Related to Investigational Medicinal Products
by Christine Milligan, PhD, MBA, Esther Sadler-Williams, MSc, MRPharm S, and Karen Gram, MSc (Pharm)
This article presents a summary of a survey on patient experience related to Investigational Medicinal Products (IMPs) conducted by the ISPE IP COP.

Good Manufacturing Practices for Halal Pharmaceuticals
by Kenny Peng, MASc, RAC, PEng and Roziah Hanim Abdul Karim, BS
This article presents an overview and analysis of a new national standard on halal pharmaceutical products, MS 2424:2012, published by Malaysia, a member of PIC/S.

Regulations and Guidelines of Computer Systems in Drug Manufacturing – 25 Years Later
by Orlando López
This article presents a regulatory review of the current requirements applicable to computer systems in the manufacturing environment.

Innovative Mixing Technology
by Gabriela Mikhaiel
This article discusses fundamental challenges in powder mixing and an innovative mixing technology aimed to improve blending processes.

Members Are the Strength of ISPE 
by Nancy Berg
ISPE President and CEO Nancy Berg discusses the importance of active participation in the Society and how it leads to the development of pivotal events, initiatives, and publications that are shaping the industry and strengthening regulatory relationships.