Validation – need and necessity
Life Sciences companies have been struggling with the validation of automated systems for decades. While it used to be restricted to the lab and production floor, since the 1980s it has filtered through to the rest of the business operations and consequently also to the IT department. This is naturally understandable considering that validation lies at the foundation of limiting risks for patients, i.e. the end users. But viewed from a business perspective, ever-rising costs form an unpleasant downside to the growing importance of validation.
Rising costs
The industry average for validation costs as a percentage of IT projects in the pharmaceutical market currently stands at between 20 to 25 percent. Only a few large companies, including Pfizer and GSK, have presented cases whereby the percentage was kept below 5 percent. The fact that validation costs weigh much more heavily on the implementation budgets of smaller companies means the opportunities for making improvements are relatively greater in this segment.
Points for improvement – cost-savings
Goldfish sets out the main factors involved in realising a comparable improvement in the accompanying white paper. The key point is a clear validation strategy that centres on risk-based compliance. The white paper outlines how an effective approach can lead to savings in the field of validation. It explains how the validation costs of an IT implementation can be drastically reduced via a step-by-step plan. The key point, namely ranking risk, is also discussed in greater detail.
Download the white paper to discover whether you can also draw lessons from this as an organisation. Please also feel free to contact us if you have any questions concerning this topic or if you would like to respond to this article. We are also interested in your experiences!
http://www.pharma.goldfish-ict.com/content/The%20Price%20of%20Validation_EN.pdf
