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Corrective and Preventive Actions

Keep production running

FDA requirements for quality, validations, complaints and recalls set high standards for compliance. To meet the challenges of operating in a regulated environment, systematic, analytical processes cut through the complexity of compliance, helping teams to set priorities, troubleshoot issues effectively, complete well-documented investigations and implement effective CAPAs. 

When advanced critical thinking processes are integrated into CAPA systems and software, teams not only improve compliance but ultimately reduce regulatory issues and their associated costs.

What Diagnostics Is

Integrate analytic thinking into processes, monitoring systems and software

  • An effective CAPA program begins with prioritizing relevant issues

    Effectively clarifying deviations and prioritizing them allows investigators to assemble appropriate teams and apply appropriate methods to conduct effective and compliant investigations.

  • Training and facilitation can dramatically improve root cause analysis

    Investigators capable of applying a systematic RCA process are better able to gather the data needed to find true cause efficiently, take effective action and establish effectiveness checks. This eliminates investing in expensive, unnecessary counter-measures and reduces recurring problems.

  • Eliminate distractions when the pressure to perform is high

    A structured issue resolution process helps investigators focus and act rationally and constructively even in emergency situations. When risks or costs are high, following a structured analytic process helps investigators maintain momentum without distractions.

  • A common investigative approach prevents misunderstandings and builds confidence

    A shared approach and language unites functions and eliminates the silos that can slow investigations. In addition, consistent documentation of the thinking behind compliance efforts provides clarity within the organization and for auditors.

Integrating People, Process and Technology

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Rising expectations and data overload can stall investigations and CAPAs.

Organizations achieve greater impact by developing analytic skills broadly across their workforce and using technology and systems that support a transparent compliance process.

 

Instead of limiting quality efforts to specialized teams, expanding the focus on quality across the organization improves responses to compliance issues while supporting a broader, proactive approach to continuous improvement.

Success Stories

Challenges

The site managers at a global biopharmaceutical company explored opportunities to reduce the number of investigations as well as the number of days required to close their investigations. The plant did not have a standard, systematic approach to finding the root cause of manufacturing deviations.

33%

Reduction in required investigations

13%

Closings dropped by this amount, compared with the previous year

Results

The plan to improve the investigation process and incorporate KT as the investigation methodology was completely developed and implemented in less than six months.

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