Roadmap to Process Understanding

Sokrates©

Quality Risk Management System

Sokrates logo

Sokrates© is the product of excellence of PAT Way Solutions, an innovative tool for the identification of critical process parameters, critical aspects of production systems and for the management of corrective actions useful for mitigating risks to the quality of the Product-Process.

Our QRMS (Quality Risk Management System) has been specifically developed to allow MAPPING OF PRODUCTION PROCESSES and following RISK ASSESSMENT, in order to guarantee Product Quality (GMP).

Furthermore, it is able to manage all aspects relating to SAFETY, HEALTH and ENVIRONMENT (EHS).

The tools currently used for Risk Management in the GxP area are completely “static” with consequent difficulty in involving all SMEs in the definition, review, approval and monitoring of the Control Strategy over time.

Unlike traditional tools like spreadsheets, our system is based on a clear, effective and intuitive interface capable of supporting project teams in sharing assessments. Includes charts, dashboards, summary reports and export in protected/editable format.

Sokrates© allows companies to map their production processes, rationalize risk scenarios (GMP/EHS) by identifying the Critical Process Parameters and Critical Aspects of manufacturing systems and consequently being able to design a CAPA Plan, having a holistic vision of production and critical issues.

These characteristics make it an essential tool to support:

• CONTAMINATION CONTROL STRATEGY (CCS) REVIEW
• TECH TRANSFER
• VALIDATION STRATEGY REVIEW
• PRODUCT ANNUAL REVIEW

Within each risk scenario the following are therefore identified:

  • The process parameters
    • CPP – Critical Process Parameters
    • PPI – Process Performance Indicators
    • CQA – Critical to Quality Attributes
  • The manufacturing systems impacted
  • The cleanrooms in which these systems are located
  • The critical aspects of the manufacturing systems, according to ASTM E2500, together with the sources of variability, the control and verification strategy
  • The reference documentation from both the product and system point of view
  • The type of record that supports the traceability of the manufacturing process

The system has a set of reports and graphs capable of summarizing:

  • the description of the process, products, of manufacturing systems
  • the documentation associated with these products and systems
  • the risk assessment relating to a particular production line or product but also by type of risk (for example cross contamination,
    data integrity)
  • the control strategy adopted
  • the process parameters
  • the action plan (CA/PA Plan or perhaps better PA/CA Plan given that first it is necessary to prevent and ultimately correct)
  • the quality events
In the European Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 relating to medical devices in Annex 1 it says: “Manufacturers shall establish, implement, document and maintain a risk management system.
Risk management is understood as a continuous iterative process throughout the entire life cycle of a device that requires constant and systematic updating. In risk management, manufacturers must: a) establish and document a risk management plan for each device (…)”

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