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