Companies are bound by the regulations that call for generation of records and documentation of all product-related activities. As a result, managing the ongoing accrual of information has become a formidable task for the industry. What is certain is that the demand for records is not lessening. Indeed, it is becoming greater as companies merge, split off, partner, and outsource. The ability to produce records electronically as well as in paper form brings challenges in imposing order and avoiding chaos. How then can organizations make sense of the documentation requirements? A good understanding of what document management really means is the best starting point. This chapter answers the following questions:

  1. What is data mining?
  2. What is product life-cycle management, and what does it mean in terms of documentation?
  3. What is a software document management system?
  4. What kinds of systems are there for electronic record keeping?
  5. Can we outsource document management?
  6. If we use SaaS, how can we be sure the system is compliant and secure?
  7. If we use contract research or manufacturing, can we rely on the contractors' documentation practices?
  8. Are there specific regulations that state there must be a central records facility with a designated individual to manage it?
  9. Is there an efficient way for us to control a set of external standards ...

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