The adoption of computers into every aspect of the pharmaceutical industry has been enormous. Some estimates would put productivity and efficiency gains across the pharmaceutical industry at 2–3 times what they were previously. However, they are only just beginning to have an effect in the areas of training and document management, which have traditionally been managed by people and paper systems. With increasingly strict regulations and the growing complexity of processes and training requirements, there are even greater efficiency gains, as well as cost savings, to be achieved by adopting electronic document management systems (eDMS), learning management systems (LMS) and systems for the electronic signing of documents.

As a skipping stone creates ripples in a lake, SOA can help create benefits that quickly ripple through many other areas of the organization and partners.

Historically, the main purpose of laboratory information management systems (LIMS) has been to track and manage samples in the laboratory. LIMS originated nearly 30 years ago as a rudimentary method of automating manual, error-prone processes in the laboratory and, with the growth in adoption of technology, became the de facto benchmark for laboratory control and management.

In recent years, AI has become important in a number of fields in helping to make better use of information, increasing efficiency and enhancing productivity.

All sectors of manufacturing are under continual pressure to bring new products to market quicker, stealing a march on the competition and maintaining their revenue stream.

The pharmaceutical sector is a billion dollar industry with a huge responsibility towards its customers and investors. The main tools for fulfilment of this responsibility are ensurance of compliance and maintenance of control. It is a time-consuming job to uphold these responsibilities, and many important decisions regarding this subject are taken every day. It is important to make carefully considered decisions and follow them up. It is also essential to stop once in a while and reconsider their validity and relevance.

A new Good Automated Manufacturing Practice (GAMP) guide on IT Infrastructure Control & Compliance was launched in Chicago (IL, USA) 23 August 2005.1 The guide is intended to support pharmaceutical companies in their effort to establish a well-defined and compliant infrastructure. This article discusses different aspects of the guide that may support your organization in getting — and keeping — your infrastructure under control.

Regulatory and compliance requirements are frequently changing, and if that wasn't enough there is also numerous varying regulations across products, services and countries.

Does 21 CFR Part 11 Provide Any Benefits? 01 August 2005 By: Christian Stage

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.