Close the Loop on Risk and Non-Compliance

Implementing effective and comprehensive CAPA in a timely manner continues to be a major problem among medical device,
pharmaceutical and biological companies. The lack of follow-up and close-out are frequently mentioned. According to recent
trends, approximately 30% to 50% of all citations are CAPA-related. To ensure compliance and quality, organizations must
close the loop on risk and non-compliance and develop closed-loop systems that detect existing potential quality problems and
facilitate rapid problem resolution and closure.

While all organizations hope to avoid the root causes that trigger corrective actions, reality dictates otherwise. CAPA
management becomes more than just a process, it is the core process of a well-established compliance and quality program.
The automation of CAPA coupled with a multinational CAPA team ensures complete visibility when deviations, potential
discrepancies or non-conformances are discovered.

As depicted in the figure below, CAPA is central to the implementation of an effective, closed-loop, continuous improvement
process that focuses on prevention and quality.

Figure 1 – Closed-loop compliance process control system

A well-established CAPA management automated system should include the following key features to ensure compliance and
quality:

• Powerful, configurable workflow engine for the management of proactive and reactive events
• Integrated document/content management
• Enterprise collaboration
• Integration with modules that support non-conformance, audit management, change control, incident, customer
complaint, deviation, out-of-specification results, and any other reactive quality processes
• Custom report generation
• Electronic forms integration to ensure adaptability within specific organizations
• 21 CFR Part 11 electronic Signature Capabilities
• Search and retrieval
• Statistical and graphical trend analysis and visualization
• Flexible custom report generation
• Documented API's for interoperability with other enterprise technologies such as ERP, LIMS and ERP
Integrated CAPA Management Systems Best Practices

The following current best practices are designed to help mitigate risk and drive quality in a holistic manner across today's
regulated organizations. The industry is evolving from the deployment of standalone CAPA systems to integrated compliance
process control systems that treats CAPA as an integrated enterprise process. The following best practices are an excellent
starting point to help avoid implementation problems and regulatory issues.

1. Establish enterprise-wide CAPA program. Management of CAPA impacts multiple areas of the organization. It
requires orchestrated coordination of activities and collaboration across the global enterprise through the complete
CAPA lifecycle. Current best practice is to develop CAPA systems as a strategic initiative versus a departmental
project. This ensures effective monitoring and control of all CAPA incidents across the organization and facilitates
aggregated management control.

2. Ensure top-down management support. Enterprise initiatives require support from the very top of the organization
to ensure that resources are allocated appropriately and policy is consistently managed across the organization. It is a
highly recommended best practice that a cross-functional team be established with an executive champion who has
the authority to specify corporate policy with respect to CAPA.

3. Enterprise collaboration. An important current best practice designed to improve operational efficiency leverages
integrated collaboration technology to facilitate the sharing of quality and CAPA knowledge across the entire
enterprise.

4. Ensure compliance with 21 CFR Part 11. It is common best practice to develop all CAPA systems in compliance
with 21 CFR Part 11 requirements. Since CAPA is inextricably linked to other automated quality processes, it is
important that a consistent approach to 21 CFR Part 11 be adopted across all quality systems. Remember, Part 11
provides governance for electronic records and signatures–not just electronic signatures.

5. Incorporate training and competency management as part of the global solution. A recommended best practice
is to training and manage the competencies of all technical and business users that manage or use the integrated
CAPA system. Leverage triggers of the CAPA system to track and manage training scheduled requirements in support
of current regulations.

6. Do not over-customize. Over-customization is the single biggest factor in increasing costs. Amadeus delivers an
effective solution for the management of corrective and preventive actions that adheres to the best practice included
herein. Where practical, leverage off the shelf technology.

7. Establish effective written procedures prior to automation. Many times, regulated companies have a tendency to
automate bad processes. This is often the case when technology is purchased in advance of planning. It is current
best practice to have effective written policies and procedures in place for CAPA governance that are consistently
communicated across the enterprise. These procedures should be examined and streamlined prior to mapping them to
automated systems. Effective manual procedures may make poor automated procedures. Automation most often
helps streamline processes and may result in the elimination of steps that may be appropriate in the manual world but
are unnecessary in the world of automation. For example, it is common for most CAPA procedures to include the
gathering of supporting information during the investigation phase. In the manual process, this information is collected
from file cabinets, duplicated, and distributed through corporate mail systems (not email). In the automated world, the
duplication and distribution through mail (not email) systems is eliminated due to electronic systems capability.

8. Develop a migration strategy upfront. This is the most over-looked step in many compliance initiatives.

9. Validate the integrated system. It is current best practice to validate all integrated quality systems. CAPA systems
fall into this category. Validation ensures system integrity and repeatable results throughout the CAPA process. It is
important to establish a set of user requirements for the system so that all validation activities can be performed in
accordance with intended use.

10. Establish compliance intelligence. Compliance intelligence is the integration of compliance process control systems
and business intelligence systems. The integration of the two technologies forms a unique compliance intelligence
system that allows management to carry out its management controls obligations as stipulated by 21 CFR 820.100.
Current CAPA regulations require management to provide oversight and governance throughout the entire process
and across the enterprise. Uniquely, Amadeus' compliance intelligence features enable management team members
to view all open CAPA processes across the organization and determine status. It provides them with "actionable
intelligence" that facilitates timely management decision-making.

Amadeus International – The Step Above Compliance

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