R. M. Baldwin, Inc. Corrective / Preventive Actions (CAPA)  Tools and Resources

Corrective / Preventive Action
(CAPA)


CAPA Training Programs, CAPA Guidelines Documents, CAPA Facilitator Standard Edition


CAPA Flowchart

 

Implement a CAPA system that will satisfy regulatory requirements and form the basis for an effective continuous improvement plan!

 

R. M. Baldwin, Inc. offers a series of helpful tools that can assist in setting up and/or maintaining a comprehensive, well documented Corrective / Preventive Action program in your organization.


CAPA Facilitator
TM

CAPA Facilitator is an integrated software solution that manages the entire Corrective / Preventive Action process. Using a logical and intuitive approach, the program guides the user through initiating, investigating, resolving and documenting corrective or preventive actions. It will benefit any quality system by providing the tools needed to establish and support an effective corrective / preventive action program.
 

“Since using CAPA Facilitator, our department has been able to save time, increase productivity and improve quality. The software is easy to use and install, and upgrades were sent on a timely basis. It has provided us with a straightforward step-by-step method for documenting corrective and preventative action activities. With CAPA Facilitator, Camtronics Medical Systems has significantly reduced the time to process issues that arise, allowing us to be even more responsive to our customers needs.”

Leon Milbeck
Camtronics Medical Systems

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CAPA Guidelines

A Corrective / Preventive Action policy is essential to an effective quality assurance system. CAPA Guidelines describes the specific steps that are required to implement a successful CAPA program. It contains valuable information for completing and documenting corrective and preventive actions as well as sample forms that can be used or modified.

View online or download in various formats.
 

CAPA Training

The key to establishing a successful program is to make sure that it is fully understood by those who use it.
CAPA training  is a slide presentation intended to complement CAPA Facilitator and CAPA Guidelines. The training includes the essential aspects of corrective / preventive actions and can be used to increase employee awareness and understanding of the process.

                                                         
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Why a CAPA Program is essential for a quality system:

Continuous quality improvement is an important goal for most businesses and, troubleshooting and resolving problems is a typical activity in that process.The reason is obvious: problems have a financial impact on the company. A Corrective / Preventive Action system (CAPA) is an essential management tool that should be a part of every quality system. It can help assure continuous quality improvement and customer satisfaction.

CAPA is also a major area of regulatory concern for both the FDA and ISO. They have recognized that how a quality system is maintained and monitored is critical to its effectiveness. Their risk-based CAPA requirements demand a well documented system. The Corrective / Preventive Action (CAPA) subsystem of a company’s quality system is nearly always examined during FDA and ISO regulatory compliance audits. Unfortunately, many companies do not implement CAPA as effectively as they could and 30 to 50 percent of non-conformances cited are directly due to CAPA violations.

Fact: The only subsystem of a facility Quality System that the FDA always examines at inspections is the Corrective and Preventive Action program.

 

Click here to see what other industry experts have to say about why a CAPA Program is so important.

For Additional Information, Questions, or Comments   Click Here

 

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