Pharmaceutical Technologist - May 2008 - (Page 27)

Quality management things. This resulted in the development of an eDMS that offered life sciences organizations a regulatory-compliant, effective and easy-to-use method of tracking document version history, managing approvals, and monitoring and recording changes in an audit log. How would you describe your customer base? Ostensibly we set out to target the small- (30–150 staff) and medium- (150–1000 staff) sized pharmaceutical and biotechnology companies in Europe and the US. These companies needed to address the areas of eDMS and compliant training, but didn’t possess the budgets or staffing levels to implement ERP and large ECM systems. Since our launch in December, we already have one customer in each of the small and medium categories in the UK, and we are very encouraged by this. We are also finding that the larger companies, who often purchased other systems for their employees to collaborate on, are unsure how to roll it out in a compliant manner. This could be a good market for us in the future. In what way does a QMS help a pharmaceutical company? Initially, adoption of a QMS is driven by regulatory requirements. In the US, FDA inspectors look for several patterns in a quality system. They check to see that companies consistently: ● Review and approve procedures. ● Review documentation regularly. Document the required execution of operations. ● Document the training of operators, laboratory staff and other key personnel. ● Conduct investigations and resolve problems when necessary. ● Assess other systems in place to assure compliance with GMPs/GxPs and the company’s standard operating procedures. These are regulatory issues, but, ultimately, the QMS delivers a better business that has fewer recalls, less bad publicity and reworking, and more customers because of a higher quality for the same or lower price. Thus, an efficient QMS is better for business. ● training in a compliant manner. These areas can be a potentially high risk if managed badly, and this has to be factored in to price. It is a serious consideration for companies contemplating deals at the moment or in the near future. Do you have any developments in the pipeline? We are constantly reviewing feedback from the market and we think there is an opportunity in the regulatory agency electronic submissions (electronic common technical document) end of the marketplace and in creating a completely electronic ‘trial master file’. What are the challenges the pharma industry and, in particular, your sector face? For all sorts of reasons — too numerous to list here — profit margins in the pharma and biotech sector are being eroded at a very high rate. Freeing people up from non-value-added activities, such as attempting to locate documents in cluttered email systems or signing and storing documents manually, to focus on the core business is becoming a priority. Our target market is always price-sensitive, but in discussions we’ve had recently with some of the bigger pharma players, they indicated that the value of smaller companies when being purchased, or milestone payments received for licensing arrangements, significantly increased if the smaller companies managed their documents, processes and If previous experience is anything to go by, regulations will only become stricter and more pervasive. The author says ● ● ● ● One of the most significant changes in the pharma industry is the adoption of computer technology, which has provided huge efficiency gains. A quality management system is usually influenced by regulatory requirements, but it has numerous advantages for businesses and can help to avoid recalls and bad publicity. Some companies are reluctant to use a quality management system because they are afraid of change and failure. Regulatory requirements in the future will probably be stricter and will be prevalent throughout the drug discovery process. How do you think regulations will change in the future? If previous experience is anything to go by, regulations will only become stricter and more pervasive. We are already seeing them moving back up the development pathway of drugs into the discovery phase. Our headquarters are in Nottingham (UK) where there are many university spin-outs with good technology in the research stage, and it amazes me that they are talking about regulations. Five years ago, they would not have had any idea that their work would eventually fall under regulatory bodies. This is nothing but good news for us, and companies similar to us, as some systems make compliance affordable and manageable for all businesses. I think we’re in the right place at the right time. Check back in 3 years to see if I was right! PT Keith Williams is founder and CEO of Good Products Ltd (UK). www.goodproductsltd.com www.ptemagazine.com 27 http://www.goodproductsltd.com http://www.ptemagazine.com

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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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