Quality

Medical Device CAPA Software Systems

21 CFR Part 820 QSR Compliant Medical Device Corrective Actions (CAPA) Software Systems

MasterControl's medical device CAPA software system is designed for the overall effort to investigate and correct quality issues to prevent recurrence. CAPA is an important principle of the Quality System Regulation (QSR) outlined in 21 CFR Part 820. Specifically, Section 820.100 requires manufacturers to establish and maintain procedures for implementing CAPA that would cover products, processes, and the quality system.

Medical device corrective action software is equally important for medical device manufacturers that are ISO-certified. Both ISO 13485 and ISO 9000 require corrective actions and remedial processes to correct nonconformance and prevent their recurrence.

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Data Sheet: MasterControl CAPA
FAQ: 21 CFR Part 820 – ISO 13485 Harmonization
Industry Brief: The 4 Phases of CAPA Maturity: A Guide to Mastering Quality Event Management Industry Brief: Simplify CAPA in 7 Steps

The Importance of MasterControl Medical Device CAPA Software Systems

Medical device manufacturers realize the importance of producing medical devices that are reliable and safe to use. Companies introduce various testing procedures to measure a product's quality and gauge efficiency of processes across the enterprise. It is crucial to adhere to the regulatory standards laid out by ISO and FDA authorities. Dealing in life sciences, medical device companies take many precautionary measures to assess and test their manufactured devices. Management executes several types of audit programs to assess the performance of the devices and also the processes executed during the entire manufacturing cycle.

The outcome of audits brings forth several issues that illustrate the weaker business areas. Corrective actions are used for identifying and presenting solutions for issues whereas preventive actions are applied for preventing recurrence of these issues. Therefore, implementing a CAPA program is vital to any company's survival in the market. For this reason, several kinds of medical device CAPA software systems are available. The MasterControl medical device corrective action software system provides companies with a compliant solution for all issues that surface during audits.

MasterControl Medical Device CAPA Software Systems is Connected

An effective CAPA program is the center of entire the quality system - addressing and presenting possible remedies for resolving issues. The foundation of a CAPA program is laid out by identifying and documenting all details of an issue, recording the communication between different stakeholders, and taking steps to resolve issues. The MasterControl medical device CAPA software system is a centralized web-based solution for providing authorized users with a common platform for analyzing the issues, conducting thorough research, documenting possible solutions, and coming to a final conclusion about resolving such issues. Solutions are then published across the enterprise for each user to follow a documented standard. MasterControl's medical device CAPA software system provides users with the basic functionalities of documenting, routing, escalating, electronically signing and approving documents so that all the involved stakeholders are in sync with the progress of issue resolution.

A sound CAPA program must be dependable so that the company is able to rectify issues and ensure their prevention in the future. MasterControl's medical device CAPA software system is reliable and provides users with the facility of documenting even the minutest detail of an issue in an offline mode. When the user goes online, the information is merged with the online content so that at any point in time only the latest information is available to all users. The online repository is a shared platform amongst different users that leads to discussions about the issue. The sharing of ideas brings about collaboration which provides management with the best solutions for resolving issues.

MasterControl Medical Device CAPA Software is Compliant

Adhering to QSR Part 21 CFR Part 820 and CFR Part 11 has become a mandatory requirement for medical device and pharmaceutical companies. With MasterControl medical device CAPA software, companies are able to attain and sustain compliance with the FDA, CGMP, and ISO regulations which holds the key for excelling in local and global markets. These regulations demand that the CAPA system should be triggered by various sources including the Form 483 findings, ISO quality audits, customer complaints, etc. Since the MasterControl medical device CAPA software is completely automated, it allows for the collection of data through forms which reduces the chance of errors that are caused through manual entry. All the relevant information is securely captured and helps in building a profound analysis for investigating the issues.

Recognizing that validating a software solution (as required by 21 CFR Part 11) is a necessary component in FDA compliance, MasterControl's comprehensive medical device CAPA software system offers full-cycle validation, 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 the overall cost of validation.

MasterControl's Medical Device CAPA Software is Complete

Medical device and pharmaceutical companies require a competent CAPA software system that provides a complete analysis about different business processes and their execution. MasterControl medical device CAPA software provides management with state-of-the-art analytics and reporting tools for generating different types of reports that help make assessments about the actual condition of the business. These reports allow companies to measure the effectiveness of processes and also to devise strategies for resolving issues that are traced and fed onto the CAPA forms for resolution.

MasterControl's medical device CAPA software system can be easily integrated with other modules in the MasterControl solution suite, such as MasterControl Documents, and allows users to conveniently document issues, their findings, research, and their solutions. Another module, MasterControl Complaints, allows for automatic triggering of CAPAs, which helps companies easily correct and prevent the recurrence of issues. This helps the management to mitigate, monitor, and eliminate the risks that are caused because of these issues. MasterControl CAPA initiates updates in standard operating procedures for which management must specifically train employees throughout the enterprise. When integrated with the MasterControl medical device CAPA software system, the MasterControl Training module also enables management to train employees without spending extensive resources.