Pharmaceutical & Biotechnology Corrective Action (CAPA) Software Systems

MasterControl Pharmaceutical & Biotechnology Corrective Action (CAPA) Software Systems Help Biotechnology & Pharmaceutical Companies to Comply With GMP 21 CFR Part 211 and 21 CFR Part 11

A Pharmaceutical and Biotechnology Corrective Action and Preventive Action system is especially designed for the overall effort to investigate and correct quality issues to prevent recurrence -- is an important principle under the Current Good Manufacturing Practices (CGMP) found in 21 CFR Parts 210-211, which cover the pharmaceutical and biotechnology industries.

Although the regulation does not use the term "CAPA," Section 211.192 essentially requires CAPA by requiring a thorough investigation of any discrepancy or failure of a batch (or any of its components) to meet specifications. It also requires a written record of the investigation, including conclusions and follow-up which is available in the pharmaceutical and biotechnology CAPA software.

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The MasterControl pharmaceutical & biotechnology corrective action systems are an integrated quality management suite which is configurable and easy-to-use software solution that helps pharmaceutical and biotechnology companies attain and sustain GMP compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl offers full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

How can MasterControl Pharmaceutical & Biotechnology CAPA Software Systems Benefit You?

MasterControl's pharmaceutical & biotechnology CAPA software is a robust, easy-to-use solution designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to GMP compliance such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that pharmaceutical manufacturers face:

GMP and Part 11, 211.192 CAPA Management Challenges		MasterControl CAPA™ CFR Part 11 Compliant Software Solution
Inefficient CAPA System Paper-based and hybrid CAPA systems are inexpensive initially. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during inspections and audits.		Efficient CAPA Process Management Software MasterControl pharmaceutical and biotechnology corrective action system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire CAPA process, from initiation to investigation and all the way through closure. Provides a secure, centralized, and Web-based repository for all CAPA documents.
Disconnected CAPA Processes A CAPA may be triggered by Form 483 findings, quality audits, customer complaints, or some other source. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable.		Connected CAPA Management Software System MasterControl pharmaceutical and biotechnology CAPA software integrates the CAPA process with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.
Poor CAPA Reporting When customer complaints, deviations, adverse events, and other incidents that can trigger CAPA 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 pharmaceutical and biotechnology CAPA system requires re-entering data from hard copy into an electronic system, a process prone to delay and mistakes.		Efficient CAPA Reporting A CAPA form can be launched directly from another form (i.e., customer complaint, etc.) to streamline the CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
Lack of Oversight Poor implementation of CAPA (a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.		Increased Oversight MasterControl's pharmaceutical and biotechnology corrective action software tracks quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. Provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the CAPA process and can be more proactive about improving their quality system.

Features of Pharmaceutical & Biotechnology Corrective Action Software

Here's a summary of MasterControl CAPA's powerful features:

Best-Practice Forms:MasterControl provides best-practice electronic forms and workflow routes that can be used as is or customized based on a company's needs. The solution includes:

• An "8D" process to guide the quality team through every step of CAPA implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of recurrence.
• A CAPA form that can be configured to show the initiator only the relevant information to this step and to require completion only of fields related to data entry.

Connected Quality Processes: MasterControl is designed as a "closed loop" solution, streamlining processes, interconnecting different quality subsystems, and tracking quality incidents that can escalate into a CAPA. For example:

• A CAPA form can be launched directly from another form (i.e., customer complaint, audit findings, etc.) to streamline the CAPA process. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
• Relevant data from a form that could potentially require a pharmaceutical and biotechnology corrective action system is automatically entered into a CAPA form, reducing data entry and eliminating errors from manually transferring information.
• Through the Internet, customers, vendors, and others outside the company can submit a form, such as customer complaint or product issue report, that could lead to CAPA. Off-site and traveling users can also complete forms pertaining to the CAPA process without being connected to the MasterControl system. They can complete forms offline and then upload.
• CAPA can be integrated with the training application for a more efficient system. A CAPA that causes a change in product design or function will invoke training tasks upon approval of the change. MasterControl can automate distribution and grading of online exams, which can be used as proof of personnel competency during FDA inspections or audits.

Advanced Analytics and Reporting: With MasterControl pharmaceutical and biotechnology CAPA software, CAPA coordinators can monitor the entire quality management lifecycle, from input to closure. They will get a complete picture of the quality system with the help of the following reporting capabilities:

• Ability to dynamically capture, trend, and link data needed to solve problems, improve processes, and implement preventive measures. A variety of reports (issue summary, aging/overdue, cycle time, etc.) come standard. You can customize reports for issue review, problem prevention, etc.
• Data can be grouped together by a date interval and then charted over a date range in a pharmaceutical and biotechnology corrective action software. For example, the number of customer complaints can be totaled for each week and charted for the last year. Data can be summarized in multiple levels, so CAPAs can be reported by product, department, and root cause.