Volume 21, Number 2 Table of Contents Articles Addressing 21 CFR Part 11 Requirements with an Automated Configuration Audit Trail and Version Management System by David Deitz This article describes a computer based...

Integrated Strategic Planning: New Horizons for Infrastructure by David M. Jonik, Gary D. Anderson The process of physical planning should provide a means of advancing strategic corporate goals, leading to sustainable...

Operation and Maintenance of Process Control Systems in the Pharmaceutical Industry by Volker Teuchert This article presents a summary of VDI/VDE 3517, Part 4: Operation and Maintenance of Validated Systems (ongoing...

Communication Failure Equals Project Failure by James E Teigen This article presents examples of project problems caused by lack of communication, and how increasing communication can minimize these problems. Meeting the...

Efficient Allocation of Construction Risk in Engineering by Richard W. Pearse This article discusses key economic considerations when negotiating the terms and conditions of a contract with an engineering company to...

Consumer Product Safety Commission Update on Child Resistant Packaging And So Was the Pharmaceutical Industry by Dominick Smith This article is about the fascinating history of a drug invented at the turn of the last...

Structure for Compliance in the Supply of Containment Systems Heightening the Success of a Project Through the Use of a Technical Program by Julie-Lea Lipszyc, Costa Nicolainas, Isabel Piraux, Martine Rondeau A...

Plant-Centric Integration -- A Value Proposition for Pharmaceuticals by David E. Woll This article discusses a proposal for business unification and information empowerment that supports those requirements. The Problem...