Pharmaceutical Technologist - May 2008 - (Page 26)

Keith Williams is founder and CEO of Good Products Managing the future The pharmaceutical industry is dominated by technology, which has opened the door for businesses such as Good Products that provide enterprise content management solutions. CEO, Keith Williams, tells us about the new age the industry is entering. You have more than 18 years of experience in the pharmaceutical industry. What are the most significant changes you have observed? 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 and systems for the electronic signing of documents. Have these changes had a positive effect in the industry? On the whole, yes, but software has not necessarily delivered a better user experience. The regulatory tail has generally wagged the business process dog, usually at the expense of things being easier for the user. With the power of collaborative tools configured for regulatory compliance, such as g-docs, the user can perform tasks in Word, Excel, Outlook and Internet Explorer, but in a controlled environment. The user benefits because there is one place to go to work on documents or take training, and the business benefits because document versions and collaborations are conducted on a central server, and all the data and audit trail are in one place too. In your view, what stands in the way of a company implementing electronic quality management systems (QMSs)? Usually a combination of: ‘Not invented here’ — we already have a great paper system. ● Not understanding the cost benefits and fear of high implementation cost. ● A fear of change, new skills to learn and failure. ● Compatibility issues with existing software systems. Normally the above occur in that order. ● What spurred your interest in management systems? During the years, I had seen very expensive (from a software license perspective) enterprise content management (ECM) and enterprise resource planning (ERP) systems that also managed documents and training. These systems forced businesses to adopt the ERP way of working, rather than adapt to existing business processes. This had a negative four-fold effect: ● Implementation was costly as systems and processes had to be configured. ● The testing and validation was complicated because quality systems interfaced with financial systems and often used the same databases. ● Training was a prolonged affair as the user had to learn a completely new way of doing things. ● Business owners and shareholders were happy because they felt more in control, but systems administrators were unhappy as they had to build up teams to manage the new system. Additionally, people using the new system were unhappy too as they felt it added to their already very full day. Eventually, people discovered workarounds to avoid the perceived ‘clunky’ new system until they were ready to submit the first draft document. Thus, a lot of interchange and collaborative data was lost in management by email or local storage of documents. Our company concluded there had to be a better, faster and more cost-effective way of doing 26 MAY 2008 PHARMACEUTICAL TECHNOLOGIST

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - May 2008

Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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