Volume 2 Number 1
The Applicability of the US National Institute of Standards and Technology's (NIST) "Engineering Principles for Information Technology (IT) Security" to Modern Corporate IT Security. Validation Management Systems: Time to Speed Up Validation. The Myth of Software Validation. Risk Management - Becoming Consciously Competent in the Face of New ICH Requirements. Improving Time to Market: Leveraging Clinical Trials Management System (CTMS) Technology for Better Data Access and Integration.
Volume 1 Number 4
e-Learning: Too Much 'e' and Not Enough Learning. Impact and Interpretation of the FDA's NEW Guidance for Industry on "Computerized Systems Used in Clinical Investigations": Security and Access Control. The IT Supplier Audit. The Dawn of the First Generation of Pharmaceutical Data Standards. A Pragmatic Approach to the Testing of Excel Spreadsheets. Integrating GCP Best Practices with Computerised Systems - Co-existence with Quality Values.
Volume 1 Number 3
Computer Systems Validation (CSV) - A Best Practice Guide for Compliance Management. Qualification of Windows Servers (Part 2). The Software Patching Dilemma in Pharmaceutical Manufacturing. A Pragmatic Approach to the Specification of Excel Spreadsheets.
Volume 1 Number 2
Qualifications of Windows Servers. The Challenge of Maintaining IT Quality in the Life-Science Industry. Practical and Cost-Effective Risk Assessment Approaches for the Validation of Commercial Computerised Systems. Enterprise Compliance Management Systems (ECMS): Choosing the Right System and the Real Costs Involved. A pragmatic approach to the Validation of Excel Spreadsheets - Overview.