| The loss of potential profitability is the horror of all | | | | 3 This increase is attributed to the combined |
| horrors and the regret of all regrets---at least for | | | | effects of increased regulation in the industry and |
| business owners and other stake holders in the | | | | inefficiencies that exist throughout the product |
| life science industries. | | | | development process in areas like clinical |
| Wouldn't they do something? | | | | development, manufacturing, supply chain, and |
| The casual observer might disagree. After all, if a | | | | sales and marketing. Technologies exist today |
| loss of potential profitability was imminent wouldn't | | | | that can eliminate unnecessary delays in literally all |
| any business professional immediately address the | | | | of these areas and more."1 When referring |
| issue?" | | | | specifically to documentation control, The Gartner |
| The answer is that no he or she would not. | | | | Group estimates the following: "...that about 80% |
| Why? | | | | of a company's documents reside on users' |
| In many cases pertinent profitability issues are not | | | | desktops and that about 25% of those |
| addressed--not because life science professionals | | | | documents are subject to regulatory compliance. |
| aren't aware of the issues themselves but | | | | 4 Due largely to a lack of adequate document |
| because 1) there are various pertinent issues to | | | | management technology, these documents are |
| juggle simultaneously and the race of priorities | | | | frequently lost, stolen, incorrectly approved, and |
| becomes confusing OR 2) the issues are haplessly | | | | or experience revision control problems - all of |
| underestimated. Either way, the territory of | | | | which cause needless delays and added costs."2 |
| potential profit loss is obviously a dangerous field | | | | Companies that consider these facts should also |
| to breach and will hopefully provide enough | | | | consider the incredible ROI benefits and |
| stimulus for future managerial action. | | | | advantages that web document management |
| A Contributing Factor: Lack of Web Document | | | | software can provide. Consider the following: "...in |
| Management? | | | | the Fall 2004 issue of Pharmaceutical |
| Document management has long been a topic on | | | | Manufacturing, Novartis claims that using electronic |
| the corporate table and the automation of | | | | solutions cut the company's costs by 40 percent |
| documentation control with web document | | | | and improved cycle times by 70 percent at its |
| management software is an attractive solution. | | | | site in Suffern, New York. Novartis further claims |
| However, many life science companies stay | | | | that one of the keys to their success involved |
| surprisingly loyal to frustrating manual | | | | incorporating the solution into many aspects of |
| documentation processes. Some venture a bit | | | | the organization, including the direct labor areas, |
| further with centralized or hybrid document | | | | quality, IT, and maintenance."3 |
| management solutions but still remain disappointed | | | | Conclusion: Is web document management for |
| when connectivity between departments and | | | | everyone? |
| other satellite offices remains at ground zero. | | | | It would seem that the research unhesitatingly |
| What's the Return on Investment? | | | | points toward web document management |
| According to an online article which quotes a | | | | software but every company will have to weigh |
| revealing statement from a Tufts study it seems | | | | the pros and cons of investment. Some may find |
| that these inefficiencies (likely related to | | | | that web document management software is the |
| documentation control in many cases) are | | | | perfect way to further the mastery of quality |
| certainly not saving companies money but are | | | | and compliance in a highly regulated work |
| instead costing significant amounts of revenue: | | | | environment. |
| "According to an ongoing study at Tufts, the cost | | | | References |
| and time of bringing a drug to market jumped | | | | 1-3 Adopting Technology in the Life Science |
| from $231 million and 8-10 years in 1990, to $802 | | | | Industry: Why is it Taking so Long? |
| million and 10-12 years in 2001, to the current | | | | (mastercontrol.com/newsletter/feature |
| estimate of more than $1 billion and 12-14 years. | | | | adopting_technology_1007. |