CAPA Programs - Corrective Action Preventive Action Programs

Automating Corrective Action Preventive Action (CAPA) Programs in FDA and ISO Compliance Environments

Recent reports show that 88 percent of FDA warning letters have been issued due to the failure of the CAPA program that a company has implemented. Corrective action software can help companies avoid the failure of a corrective action program.

Corrective Action Preventive Action programs are especially designed to maximize efforts dedicated to the investigation and correction of quality issues in order to prevent recurrence. It is a regulatory requirement that both FDA inspectors and ISO auditors consider singularly critical. When implemented properly, a sound corrective action program improves product quality and safety, increases customer satisfaction, and more importantly, ensures FDA and ISO compliance.

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Things to Consider When Choosing a Corrective Action Program

With the increased convenience, reliability, and security of electronically managed documents, it is no wonder more and more companies are switching from outdated and inconvenient paper-based processes to a corrective action program that is automated. Here are a few things to consider when looking for corrective action programs:

  • Does the application answer the end user's needs?
  • Does the vendor have the domain expertise, adequate technical and financial resources, and proven philosophy to deliver a successful solution?
  • Are the end user's evolving needs and the developer's evolving development aligned so that the partnership will endure?

How Can MasterControl CAPA Programs Benefit You?

MasterControl CAPA programs are built on the principle of simplicity for companies to effectively manage the corrective action / preventive action process. Management can also integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints.

Inefficient CAPA Programs

Many companies opt for paper-based and hybrid Corrective Action programs because they are initially inexpensive. However, these systems prove to be inefficient in the long term. Within these systems, routing CAPA tasks and other documentation requires an excessive amount of man-hours. It also takes a long time to obtain approval and signatures. Even performing manual search and retrieval of documents during inspections and audits can be a cumbersome task. On the other hand, MasterControl CAPA presents companies with efficient CAPA programs that provide automated routing, notification, delivery, escalation, and approval of CAPAs and all related documentation. The entire CAPA process from initiation to investigation and all the way through closure is entirely automated which helps in simplifying the processes in the quality management system.

The MasterControl CAPA programs provide users with a secure, centralized, and web-based repository for all CAPA documents which makes the search and retrieval of documents a relatively easy task. The MasterControl Corrective Action Preventive Action Program is accessible via the Internet which helps customers, vendors, and others outside the company submit forms (such as customer complaints or product issue reports) that could lead to the launch of a CAPA. Although, MasterControl CAPA programs are primarily online solutions, they still facilitate the completion of CAPA forms by off-site users or external parties (customers or vendors), even they are not connected to the MasterControl CAPA program. After completing forms offline, authorized users can upload the forms which are then automatically updated in the repository with the latest version of CAPA forms and documents. The automatic revision control feature ensures that only the current version of a document is available, so users will not make the mistake of using obsolete or unapproved documents in the CAPA program.

Connected CAPA Management Software System

Typically, a CAPA is either triggered by Form 483 findings, ISO quality audits, customer complaints, or through another similar source. In manual and hybrid systems, these sources are not connected which makes the process of data collection slow and incomplete. It is imperative to have connection between sources as without connectivity, critical information may fall through the cracks and may result in unreliable root cause investigations. It is necessary to integrate CAPA with the quality system for a holistic approach. MasterControl Corrective Action Programs are integrated with the rest of the quality management system so that the resolution of a corrective action triggers an engineering change, an standard operating procedure (SOP) change, and/or retraining of employees on a new SOP. MasterControl's corrective action preventative action programs provide best-practice forms and workflows. The workflows are based on an "8D" process that guides the quality team through every step of CAPA implementation. CAPA forms can be simplified by showing the user only the relevant information and to only require completion of fields related to data entry.

Efficient CAPA Reporting System

When customer complaints, deviations, adverse events, and other incidents that can trigger CAPA's are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports. A hybrid system requires re-entering data from hard copy into an electronic CAPA program, a process prone to delay and mistakes.

Efficient CAPA Reporting System

Manual collection of customer complaints, deviations, adverse events, and other incidents that can trigger CAPA is usually not correctly captured. There is also a chance of misplacing this information and it is also tedious for users to manually enter data for paper reports. This can lead to excessive delays in launching a CAPA as well as mistakes in entering the actual data in the system. With MasterControl CAPA programs in place, all information is electronically captured without manual entry errors which makes it easier to launch a corrective action program directly from another program. Links are maintained so users can review a completed process and easily see what triggered the CAPA. MasterControl CAPA is an FDA compliant program that provides time-stamped audit trail, reporting, and electronic signature capabilities required by FDA's 21 CFR Part 11 regulation. All security-related features such as the dual passwords for document approval, password expiration, encryption, and certification and account lockout are available to stop unauthorized users from gaining system access.

A top reason for issuance of Form 483 is the poor implementation of CAPA programs. This usually stems from an inability to track and monitor open CAPAs and proactively improve the CAPA process. MasterControl understands the importance of tracking quality incidents that may escalate into a CAPA, such as customer complaints, audit findings, etc. Companies require the ability to generate timely reports that provide a real-time view of the CAPA process. MasterControl CAPA programs provide advanced analytics and reporting capabilities, including customizable reports and online charting that help build an increased oversight which allows management to be more proactive about improving their quality system and CAPA reports can be scheduled to be sent automatically to users on a regular basis, or on specific dates in the future. CAPAs can be summarized in multiple levels such as by product, department, and root cause. MasterControl CAPA also includes a dashboard and drill-down features.

MasterControl special team of experts is comprised of FDA industry veterans, ISO auditors, and IT professionals that have put together a comprehensive training program. With this training program, companies can successfully implement a project and realize faster software ROI. Moreover, MasterControl also ensures project success by providing the necessary technical support, expertise, infrastructure, and flexibility to meet every customer's needs, from initial installation to regular maintenance.

Contact MasterControl Today for Information on CAPA Programs

Corrective Action Preventive Action processes are central to any GxP system. MasterControl's CAPA program ensures the corrective action system improves product quality and safety, increases customer satisfaction, and ensures FDA compliance. To learn more about our corrective action program contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.