Web Document Management and Web Document Control for Quality and Regulatory Groups
Marci L. Crane
April 18, 2009
Let's be honestly direct and directly honest about quality and regulatory groups. They don't always like each other. In fact, they often resent each other. Sure. Both departments (usually necessary within highly regulated environments) are designed to keep processes clean, to keep processes effective and to--above all-- keep their respective companies out of trouble, but according to "some" regulatory departments the quality folks go a bit too far. According to some regulatory professionals for example they (the quality department) put the breaks on every endeavor in a way that often makes the company skid to an unwanted halt. "Where's the "speed" to market?" they want to know.
On the other hand the quality department KNOWS without a doubt that every action they take is absolutely necessary but greatly resent the fact that no other department seems to recognize "quality" endeavors. This little "rivalry" is manifested over and over again and no less is it manifested in the case of document management vs. document control.
Web Document Management vs. Web Document Control
When the regulatory crowd hears the phrase "web document management" they can relax and know they are in good hands. After all, web document management is simply a managed organization of documentation a virtual protected environment to keep that documentation until it's ready to be formatted for regulatory submissions, etc. On the other hand, when regulatory professionals hear the phrase "web document control" it probably isn't uncommon for them to silently scoff or subtly turn up his or her nose at the "pick-everything-apart" quality way. After all, document control requires all of those annoying controls. Controls that include audit trails, version controls, routing controls, additional security controls, reporting controls, centralized controls, etc. It's a lot to think about.
A Harmonization of Web Document Management and Document Control
Regulatory teams need web document management software that won't slow processes down and quality teams need document control software that will keep every document related process under control, all of the time----but in a manner that's faster and that keeps every other department in the company happy.
There are software solutions that exist to provide all of the features required for web document management and control software that is fast, efficient and that still manages to provide complete control all of the time. With this type of a solution, regulatory and quality groups can have their cake and eat it too.
Additional Benefits to Look For
Both regulatory and quality groups should search for a web document management/control solution that provides all of the benefits mentioned above plus the following:
Bringing Departments Together
The best technology--the right technology--is the technology that not only connects solutions but also manages to connect people across various departments. The concept is fairly obvious perhaps but one that many software vendors still fall short of achieving.
Marci Crane is a marketing communication specialist for MasterControl, Inc. in Salt Lake City, Utah. For more information in regard to web document management and control solutions that meet the standards of quality management and control solutions, please feel free to contact a MasterControl representative.
On the other hand the quality department KNOWS without a doubt that every action they take is absolutely necessary but greatly resent the fact that no other department seems to recognize "quality" endeavors. This little "rivalry" is manifested over and over again and no less is it manifested in the case of document management vs. document control.
Web Document Management vs. Web Document Control
When the regulatory crowd hears the phrase "web document management" they can relax and know they are in good hands. After all, web document management is simply a managed organization of documentation a virtual protected environment to keep that documentation until it's ready to be formatted for regulatory submissions, etc. On the other hand, when regulatory professionals hear the phrase "web document control" it probably isn't uncommon for them to silently scoff or subtly turn up his or her nose at the "pick-everything-apart" quality way. After all, document control requires all of those annoying controls. Controls that include audit trails, version controls, routing controls, additional security controls, reporting controls, centralized controls, etc. It's a lot to think about.
A Harmonization of Web Document Management and Document Control
Regulatory teams need web document management software that won't slow processes down and quality teams need document control software that will keep every document related process under control, all of the time----but in a manner that's faster and that keeps every other department in the company happy.
There are software solutions that exist to provide all of the features required for web document management and control software that is fast, efficient and that still manages to provide complete control all of the time. With this type of a solution, regulatory and quality groups can have their cake and eat it too.
Additional Benefits to Look For
Both regulatory and quality groups should search for a web document management/control solution that provides all of the benefits mentioned above plus the following:
- Integration with a Training Module - when documents (e.g., SOPs, work instructions, quality manuals, etc.) are changed in highly regulated environments, training assignments, readings and tests can be automatically launched while the training data is finally recorded for proofs of competency for all employees.
- Collaboration Features - Should allow any approved user to collaborate on any type of document file from virtually anywhere in the world. The collaboration feature should also allow those 3rd-party affiliates (e.g., suppliers, vendors) to tap into a collaboration without actually having to purchase the web document management/control system.
- Integration with QMS/CAPA - Maybe regulatory groups won't be interested in hearing about QMS solutions but it's astoundingly amazing how much QMS/CAPA solutions can do when integrated with a web document management/control system. The QMS CAPA solution in an integration with the web document management and control solutions should manage audits, customer complaints, nonconformance events, deviations, change control and CAPAs (of course). The solution should also allow CAPAs to be launched from a customer complaints forms and all related documentation should be easily managed and controlled from within the web document management/control system itself.
Bringing Departments Together
The best technology--the right technology--is the technology that not only connects solutions but also manages to connect people across various departments. The concept is fairly obvious perhaps but one that many software vendors still fall short of achieving.
Marci Crane is a marketing communication specialist for MasterControl, Inc. in Salt Lake City, Utah. For more information in regard to web document management and control solutions that meet the standards of quality management and control solutions, please feel free to contact a MasterControl representative.
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