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Document Management Systems for Developers and Buyers

For software creators developing document management systems that essentially automate compliance with regulations for various industries is of the utmost importance. For software consumers the challenge is finding document management systems that have been developed with their industry--and the regulations that govern their industry--in mind.

For Software Creators
For those software developers that currently target specified markets (e.g, medical, legal, etc.) your document management systems may have been successfully “tweaked” over the years as users have suggested enhancements, but what if a new industry opportunity presents itself? Suddently there are new regulations to consider (e.g, Department of Defense regulation – DoD 5015.02, FDA’s 21 CFR Part 11) or new standards to be “implemented” into the development plan (e.g, ISO standards). The truth for developers is that the concepts of building document management systems are similar--or almost exactly the same--but are often built with methodologies that vary in the extreme. Because methodologies vary it can be difficult for developers to consider “deep changes” or in other words time-consuming code changes or services or validation changes. However, when software developers are considering a “break out” into a new industry there is more to consider than marketing and advertising costs. Gaining a niche inside a new industry will require a change in the actual document management systems software in question. Developers should actively seek the expertise of someone who has expertise in both the industry in question and with CS development. The industry/development expert (a product manager if you will) may also represent one of the most powerful sales tools a software company has. He or she could well become a leader and teach to other less knowledgeable sales representatives. Obviously, this represents a significant investment but becomes far more valuable than extreme advertising because the industry in question begins to see the document management systems were built “for them” in particular. “Getting into the head” of the industry is far more important than a series of billboard or online impressions. The impressions will work for some companies but getting “into the head” of the industry will result in word-of-mouth recommendations and any marketer anywhere knows that word-of-mouth is worth its weight in gold.

Document Management Systems For Software Buyers
For prospective document management systems buyers, consider first the regulations that your industry currently must meet and may be required to meet in the future (e.g, five years down the road). A tissue bank for example will be looking to meet 21 CFR Part 1270-1271 and Part 11 regulations as well as ISO 9001:2008 standards and other standards required by tissue bank associations, etc. For a tissue bank, the functionalities provided by the document management systems they consider will be valuable only to a certain extent if they don’t allow users to comply with documentation regulations and standards that are required within their industry. Buyers should also take care to ensure that the software company in question has a resident industry expert who has taken part in the development and sale of their software. If there is no resident industry expert buyers should look to another developer and if no resident industry expert is to be found, then a head-to-head comparison of regulations and functionality should be created and analyzed. The best software companies will provide collateral and product data sheets that summarize this information to your particular industry’s needs. The point is that getting clear clarification on what one document control system’s functionality provides vs. another is of the utmost importance. When looking to purchase document control systems, potential buyers should also avoid considering costs. Even if budget “is not available” companies should consider the ROI opportunity and how much the ROI will add up to within 6 months, 1 year, 2 years, etc. Software developers/providers should also be able to readily proffer ballpark figures of ROI numbers.

Conclusion
Since the development of document management systems is a horizontal industry, software developers and software buyers need to weigh carefully the benefits that document management systems can provide for their respective industries.

About the Author

Marci Crane is the Lifeline Publications Editor for MasterControl, Inc. in Salt Lake City, UT. For more information regarding document management systems that streamline compliance with 21 CFR Parts 11, 210-211, 606, 820, 1270-1271, 14000, DoD 5015.02 and ISO standards, please feel free to contact a MasterControl representative.

I need to find a manual for a Pelton & Crane autoclave?

It is a "Validator Plus" model.

there 800 # is 800 659 6560 call them they might send it for free not sure

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