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Organizations that manufacture products within a GxP or Regulated environment are required to deliver quality consistently. These companies adopt a Pharmaceutical Quality Management System that ensures Assurance and Control on Quality consistently. But with stringent regulations, growing customer demands and to make a global presence, there is a natural need for the Quality Management System to be robust, effective and efficient..

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Pharma Software/Tools

Audit Magic

Utilize automated monitoring systems to track and collect compliance warning letters issued by authorities such as FDA and MHRA. Establish a centralized database for quick access. Implement data analytics to identify trends and prioritize areas for audit focus. Develop comprehensive audit plans based on the gathered insights to ensure proactive adherence to regulatory standards.

CCF Patrol

Implement an efficient Change Control Forms system in the pharmaceutical industry to manage and document any alterations to processes, equipment, or systems. Utilize a standardized electronic form that includes detailed information on the proposed change, impact analysis, risk assessment, and approval workflow. This ensures a systematic approach to change management while maintaining compliance with regulatory requirements.

CAPA Global

Implement a CAPA (Corrective Actions Preventive Actions) solution for systematic issue resolution. Utilize software to document and address problems, identify root causes, and implement corrective and preventive actions. This solution ensures compliance, enhances quality control, and fosters continuous improvement within the organization.

Risk Connect

Risk Connect is an Audit Defense System designed to ensure compliance through streamlined risk management and audit defense processes. Utilize this solution to centralize risk data, automate compliance tracking, and facilitate real-time collaboration. With robust analytics and reporting, Risk Connect enhances the ability to proactively address compliance issues, minimizing audit risks and promoting a resilient and compliant organizational environment.

QMSSpark

Implement a comprehensive Quality Management System (QMS) to ensure compliance and enhance product/service quality. Utilize software to streamline processes, document control, and employee training. With real-time monitoring and reporting, the QMS facilitates continuous improvement, risk management, and adherence to industry standards, ensuring a robust quality framework.

ELVIS LogBook

Implement a Digital Log Books solution in pharmaceuticals for streamlined documentation. Utilize electronic platforms to record and track activities, deviations, and critical events. This solution ensures data accuracy, compliance with regulatory standards, and real-time accessibility, improving transparency and accountability in pharmaceutical operations.

Pharma Blogs

You can access Pharmaceuticals Standard Operating Procedures (SOP), Guidelines, Analytical Methods, Test Procedures, Instrument Calibrations, and Validation information here.

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