CAPA Management helps companies develop a risk-based, streamlined problem resolution process. Oasis-QMS has effective CAPA handling module in the system that improves product quality and safety, increases customer satisfaction and more importantly ensures compliances with the standards such as those set by FDA/ISO or other regulatory authorities.
CAPA, is a systematic investigation of the root causes of identified defects/problems or identified risks to prevent their recurrence (corrective action) or to prevent the occurrence (preventive action).
The advanced capability of CAPA management software complements established CAPA process and enables your organization to take a holistic approach to document, plan, investigate, perform root cause analysis, perform risk assessment, implement, perform verification and effectiveness steps, resolution of quality issues.
The standard Workflow of CAPA: Initiation / corrective and preventive action plan and execution (major tasks, resources required and deliverable timeline) / implementation verification / effectiveness check / CAPA Closure / CAPA extension approval / CAPA extension (optional) / CAPA logs / CAPA reports.
CAPA Management's reporting capabilities give the tools to identify regulatory threats and areas for improvement,
includes departments; Quality assurance/control, Manufacturing, Raw / packing / finished stores, Maintenance, Supply chain,
Regulatory affairs, Formulation / analytical research developments, Information technology, Engineering etc.
Basic Workflow ...
CAPA Sources:
Connected with Deviation management, Market complaints management, OOS results, OOT results, change controls, lab / environment incidents, Equipment calibration / validation failure, Batch failure, Product recall, Stability failure, PQR, Audits etc.
The essential part of the CAPA process is to get an early signal of quality issues from your subsystems. Oasis CAPA management software has inbuilt powerful analytics and reporting capability to provide you an early indication of quality issues so that your organization can take simple corrections.
