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 (CROs) 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 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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The product development lifecycle of biopharmaceutical and medical devices is increasingly costly and complex. Moreover, regulatory authorities keep a very close eye on the CROs developing such products, which complicates clinical trials due to the steadily growing number of regulatory procedures. CROs, medical laboratories, and clinical laboratories also must comply with several stringent regulatory parameters including the 21 CDR 312.52, 21 CFR 50, 56, 312, and 812, international regulations, Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards. Since it takes a lot of resources to kick-start a clinical study, CROs want to ensure that the research adheres to the highest standards of quality. The implementation of a proven quality management system allows organizations to build an infrastructure that addresses basic quality needs. An effective CAPA program helps companies comprehensively gather and sort information so that all the issues, bugs, and anomalies traced during an audit or raised at the customer's end can be immediately resolved.
The CROs, medical laboratories, and clinical laboratories help the sponsoring company achieve its goals for manufacturing safe, reliable, and effective products. Paper-based or hybrid systems lack the necessary tools to provide a fool-proof CAPA program. The alternative is to incorporate an electronic CAPA system for better control and manageability. MasterControl CRO and medical and clinical laboratory CAPA systems provide a holistic, web-based CAPA system that catches errors and prevents them from recurring.
The MasterControl medical and clinical laboratory CAPA software system is fully compliant with FDA regulations. FDA Form 483 highlights poor CAPA investigations as the root cause behind failure for drug, biologic, and medical device manufacturers' products. FDA requires CROs and medical and clinical laboratories to maintain sound documentation that is continuously updated so that users can view and consult the latest set of standard operating procedures (SOPs), CAPAs, and other related documentation. Launching a sound CAPA program can be tricky especially if the requirement is to monitor multiple processes and observe deviances from the standard workflow. FDA regulations are stringent and violation of such requirements often results in warning letters issued to clinical investigators, institutional review boards, contract research organizations, and sponsors upon citation of any nonconformity. It is important to improve the quality of investigations and bring accurate issue findings to the front for resolution.
CROs must build a CAPA system that allows flawless data entry from various sources so that vital data does not fall through any cracks. FDA also demands that a CAPA system provide warning alerts whenever a problem is raised during clinical trials. MasterControl's CRO and medical and clinical laboratory CAPA software system provides reporting tools for generating various reports in different time periods for recording deviations, adverse events, and serious events.
The MasterControl CRO and medical and clinical laboratory software system is fully compliant with good clinical practices (GCPs). Good clinical practices demand that medical device manufacturers establish a CAPA program framework that conforms to the 21 CFR 820.100 standards. Good clinical practices also require organizations to establish an electronic CAPA system that is proficient in conducting thorough investigations. The system must have the capability to document each process and identify deviations as soon as they arise. Good laboratory practices (GLPs) require the implementation of corrective actions so that the element of risk for issues is completely eliminated. The depth and intensity of an investigation should match the potential risk to patients so that manufacturers are able to manage the CAPA program with the seriousness that it deserves.
ISO defines a corrective action as an action to "eliminate the cause of a detected nonconformity or other undesirable situation" whereas a preventive action "eliminates the cause of a potential nonconformity or other undesirable potential situation". ISO emphasizes that companies should develop a training program that provides ongoing training to staff on a frequent basis. The training should educate users about the CAPA procedures, root cause analysis, solution criteria, steps in performing investigations, documentation, and reporting requirements, The MasterControl CRO and medical and clinical laboratory software system can be seamlessly integrated with other modules that comprise the MasterControl suite of quality management applications such as MasterControl Training so that companies can build an elaborate training program for training staff about managing and resolving CAPAs. Since MasterControl software closely documents each step of a CAPA investigation, it simplifies the execution of a comprehensive investigation for resolving a CAPA. The software guides management to the exact root causes of problems, which also helps in providing possible remedies for preventing recurrence.
For more information about MasterControl's CRO, medical and clinical CAPA software, please feel free to contact a MasterControl representative.