CRO, Medical & Clinical Laboratory CAPA Software Systems

MasterControl CRO, Medical and Clinical Laboratory CAPA Software System Helps in Compliance with GMP 21 CFR Part 11 Regulations

Corrective Action and Preventive Action (CAPA) - the overall effort to investigate and correct quality issues to prevent recurrence - is an important requirement for contract research organizations and laboratories covered by the Current Good Manufacturing Practices (CGMP) found in 21 CFR Parts 210-211, 820, and 606.

MasterControl's CRO CAPA system and and laboratory CAPA system is equally important for contract manufacturers that are ISO-certified. Both ISO 13485 and ISO 9000 require corrective actions and remedial processes to correct nonconformances and prevent their recurrence.

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How can CRO and Laboratory Corrective Action Software Benefit You?

MasterControl's CRO, medical and clinical laboratory 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 FDA GMP compliance and ISO certification such as change control, audit, and customer complaints. Here's how MasterControl CAPA addresses some of the major challenges that contract manufacturers, labs, and research organizations face:

CAPA Management Challenges		MasterControl CAPA 21 CFR Part 11 Compliant Software Solution
Inefficient CAPA System Paper-based and hybrid CAPA systems are inexpensive initially. In the long term, however, these CRO, medical and clinical laboratory corrective action 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 CAPA 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 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 but MasterControl's laboratory CAPA software can solve this issue. A hybrid 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. The CRO, medical and clinical laboratory software maintains links 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 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 CRO, Medical and Clinical Laboratory Corrective Action Software

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

Best-Practice Forms: MasterControl's CRO, medical and clinical laboratory CAPA system 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's CRO, medical and clinical laboratory corrective action software 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 corrective action 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 online in the CRO, medical and clinical laboratory CAPA software, 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 ISO audits.

Advanced Analytics and Reporting: With MasterControl's CRO, medical and clinical laboratory corrective action system, 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. 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.