Advanced Web Document Management and Integrated CAPA QMS Controls
In highly regulated environments, and especially in highly regulated life science environments, CAPAs are the engine to every QMS vehicle (i.e., QMS system) and document management and controls are the frame of the QMS vehicle itself.1 Most life science companies recognize the importance of both CAPA and document management/control but often find that even with in-house expertise the Achilles' heels of QMS management can be difficult to remedy.
Weakness #1: Lack of the Event Management Funnel
Many life science companies have good CAPA systems (those companies who feel they do not have a solid CAPA system should see weakness#2) but often fail to support those CAPA systems with an event management funnel. An event management funnel should automate, manage and organize initial event/issue inputs so that not every input is being directly relayed to the CAPA system itself. The funnel is valuable because it ensures that all inputs are organized and reported (a process required by the FDA) but also serves as a station where a determination of "CAPA-status" can occur. For example, inputs from various departments (e.g., engineering, manufacturing, etc.), customer complaints, nonconformance events and deviations can be gathered and organized and if a risk assessment warrants it, a CAPA can be officially launched. Without an event management funnel, events/issues are sent directly to the CAPA system which leads to the inevitable (at least in large companies) "Death by CAPA" syndrome (i.e., too many inputs that do not necessarily require corrective actions but must be addressed once they have been included in the system). No company wants to waste valuable time investigating CAPAs that never had to be addressed in the first place! This is a significant problem for life science companies that needs to be addressed.
Weakness #2: A Faulty CAPA System
A faulty CAPA system is based on faulty CAPA processes. Faulty processes are often surprisingly derived from a dependence on in-house expertise. For example, let's say a medical device company has successfully organized their issue/event inputs and then begins a CAPA process that relies heavily on the expertise from various departments. This may seem necessary but it's actually not. Experts, for example, often fail to recognize potential corrective actions and are subject to "being out of the office" or to leaving the company all together. Besides, what expert has the time necessary to spend days or weeks in the resolution of a CAPA issue? CAPA investigation processes, according to Ken Peterson, founder and former CEO for PathWise, Inc. and current Director of Quality Services for MasterControl, Inc. "…should not rely on the dated techniques of the 80s that are built on brainstorming or expertise alone. The component needs to incorporate deductive reasoning and critical thinking concepts." Deductive reasoning and critical thinking can be built into automated forms with the right CAPA software solution and also can be taught in a relatively small amount of time in CAPA training courses.
Weakness #3: Lack of a Web Document Management System
Many life science companies still don't have a web document management system and rely on paper-based "solutions" which cause ridiculously unnecessary and expensive delays in product-to-market times, administration costs, etc. and in dangerous risks with regulatory bodies that judge many companies processes by their documentation and the processes that represent that documentation. A web document management solution when researched carefully is very likely to provide a significant ROI and more assurance in terms of regulatory compliance. All life science companies should invest as soon as possible in a web document management solution.
Weakness #4: Lack of Coordination between Web Document Management Software and the QMS
As mentioned above, the frame of a quality management system should be a good document management software system and web document management software is the most well suited for companies that are turning global at a rapid rate. Many life science companies should also have the web document management system integrated with their QMS CAPA system so that CAPA related documentation can be stored and managed in a protected virtual space and so that CAPAs can automatically be triggered from electronic process forms.
Conclusion
All life science companies should do their due diligence in terms of the web document management and QMS CAPA technology that they implement in their environments.
References
1. The information in this article, in part, is paraphrased from an interview entitled, Q&A: The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?, with Ken Peterson, the founder and former CEO for PathWise, Inc. and the current Director of Quality Services for MasterControl, Inc.
Weakness #1: Lack of the Event Management Funnel
Many life science companies have good CAPA systems (those companies who feel they do not have a solid CAPA system should see weakness#2) but often fail to support those CAPA systems with an event management funnel. An event management funnel should automate, manage and organize initial event/issue inputs so that not every input is being directly relayed to the CAPA system itself. The funnel is valuable because it ensures that all inputs are organized and reported (a process required by the FDA) but also serves as a station where a determination of "CAPA-status" can occur. For example, inputs from various departments (e.g., engineering, manufacturing, etc.), customer complaints, nonconformance events and deviations can be gathered and organized and if a risk assessment warrants it, a CAPA can be officially launched. Without an event management funnel, events/issues are sent directly to the CAPA system which leads to the inevitable (at least in large companies) "Death by CAPA" syndrome (i.e., too many inputs that do not necessarily require corrective actions but must be addressed once they have been included in the system). No company wants to waste valuable time investigating CAPAs that never had to be addressed in the first place! This is a significant problem for life science companies that needs to be addressed.
Weakness #2: A Faulty CAPA System
A faulty CAPA system is based on faulty CAPA processes. Faulty processes are often surprisingly derived from a dependence on in-house expertise. For example, let's say a medical device company has successfully organized their issue/event inputs and then begins a CAPA process that relies heavily on the expertise from various departments. This may seem necessary but it's actually not. Experts, for example, often fail to recognize potential corrective actions and are subject to "being out of the office" or to leaving the company all together. Besides, what expert has the time necessary to spend days or weeks in the resolution of a CAPA issue? CAPA investigation processes, according to Ken Peterson, founder and former CEO for PathWise, Inc. and current Director of Quality Services for MasterControl, Inc. "…should not rely on the dated techniques of the 80s that are built on brainstorming or expertise alone. The component needs to incorporate deductive reasoning and critical thinking concepts." Deductive reasoning and critical thinking can be built into automated forms with the right CAPA software solution and also can be taught in a relatively small amount of time in CAPA training courses.
Weakness #3: Lack of a Web Document Management System
Many life science companies still don't have a web document management system and rely on paper-based "solutions" which cause ridiculously unnecessary and expensive delays in product-to-market times, administration costs, etc. and in dangerous risks with regulatory bodies that judge many companies processes by their documentation and the processes that represent that documentation. A web document management solution when researched carefully is very likely to provide a significant ROI and more assurance in terms of regulatory compliance. All life science companies should invest as soon as possible in a web document management solution.
Weakness #4: Lack of Coordination between Web Document Management Software and the QMS
As mentioned above, the frame of a quality management system should be a good document management software system and web document management software is the most well suited for companies that are turning global at a rapid rate. Many life science companies should also have the web document management system integrated with their QMS CAPA system so that CAPA related documentation can be stored and managed in a protected virtual space and so that CAPAs can automatically be triggered from electronic process forms.
Conclusion
All life science companies should do their due diligence in terms of the web document management and QMS CAPA technology that they implement in their environments.
References
1. The information in this article, in part, is paraphrased from an interview entitled, Q&A: The CAPA Engine and Your QMS System - Is it Driving Your Company Forward?, with Ken Peterson, the founder and former CEO for PathWise, Inc. and the current Director of Quality Services for MasterControl, Inc.
