Equipment & Computer System Validation

1. Regulatory Compliance and Risk-Based Approach:

Curedose Pharma follows a risk-based validation approach to ensure compliance with industry standards and regulations, including 21 CFR Part 11, GxP (Good Manufacturing Practices), and ISO 9001. We ensure your equipment and systems meet the regulatory requirements of global authorities, minimizing risk while optimizing performance.

2. Validation Planning:

We begin by developing a Validation Master Plan (VMP), which outlines the scope, strategy, and approach for validating your equipment and computerized systems. The plan includes timelines, deliverables, and responsibilities, ensuring that every step of the process is structured and aligned with regulatory guidelines.

3. User Requirements Specification (URS):

Curedose Pharma assists in defining clear User Requirements Specifications (URS) for each system, ensuring that equipment and computerized systems are designed to meet your operational needs. The URS documents the specific requirements the system must fulfill to support the quality processes and comply with relevant regulations.

4. Design Qualification (DQ):

During the Design Qualification (DQ) phase, we evaluate the design and functionality of equipment and systems. We ensure that these are suitable for their intended use and capable of meeting regulatory standards. This stage involves reviewing design documentation, specifications, and ensuring alignment with the URS.

5. Installation Qualification (IQ):

Installation Qualification (IQ) verifies that the equipment and systems have been properly installed according to the manufacturer’s specifications and regulatory guidelines. This includes verifying hardware, software, and peripheral systems, as well as ensuring that all components are correctly installed and configured.

6. Operational Qualification (OQ):

During Operational Qualification (OQ), we test the equipment and systems under normal operating conditions to confirm that they perform as expected. We conduct a series of tests and measurements to assess functionality, performance, and output to ensure that they operate within predefined limits and specifications.

7. Performance Qualification (PQ):

The Performance Qualification (PQ) phase verifies that the equipment or computerized system consistently performs as intended under real-world conditions, meeting operational and regulatory standards over time. We conduct process runs and confirm that the system’s performance is stable, reliable, and reproducible, ensuring continuous quality.

8. Computer System Validation (CSV):

We provide end-to-end CSV services, including:

• Software Validation: Ensuring that software applications used in GMP environments (e.g., LIMS, SCADA, MES, ERP) are fully compliant with 21 CFR Part 11, ensuring integrity, security, and traceability of data.
• Electronic Records and Signatures: Validation of systems used to manage electronic records and signatures, ensuring compliance with 21 CFR Part 11 requirements and ensuring data integrity.
• Audit Trail Verification: Verifying that all computerized systems properly record and maintain audit trails, ensuring that any changes to critical data are tracked and traceable.

9. System Integration and Interface Validation:

If your equipment or systems are part of an integrated environment, Curedose Pharma ensures that all interfaces between systems are correctly validated. We verify data exchanges between systems (e.g., equipment interfacing with laboratory systems, manufacturing systems with quality systems) and ensure that the integration is seamless and reliable.

10. Data Integrity and Security:

Ensuring data integrity is crucial, particularly in regulated environments. We validate systems to guarantee that the data is accurate, complete, consistent, and secure. This includes ensuring proper backup protocols, access control, and data protection measures are in place to prevent unauthorized alterations and safeguard the data.

11. Validation Testing and Documentation:

Curedose Pharma ensures thorough validation testing throughout the process, documenting each phase (DQ, IQ, OQ, PQ, CSV) to create a comprehensive validation package. The documentation serves as proof that the equipment and systems comply with regulatory standards and function as required. We maintain complete traceability and audit trails to support compliance during regulatory inspections and audits.

12. Requalification and Periodic Review:

We support ongoing validation by providing requalification services to ensure systems remain compliant throughout their lifecycle. This includes periodic reviews, recalibrations, and revalidations in line with changes to equipment, software, processes, or regulations, ensuring continuous compliance and optimal performance.

13. Training and Support:

To ensure long-term success, Curedose Pharma offers training on validation procedures and best practices for your team. This includes educating your personnel on equipment operation, maintenance, and regulatory compliance requirements, enabling them to support and manage the validated systems effectively.

14. Validation for Special Applications:

We also provide specialized validation services for complex systems such as:

1. Temperature Mapping and Monitoring (e.g., cold storage, warehouses)
2. Cleanroom and Environmental Monitoring Systems
3. Automated Filling and Packaging Systems
4. Laboratory Equipment and Instruments

Benefits of Equipment & Computer System Validation:

1. 1. Regulatory Compliance: Ensure compliance with global regulatory standards (e.g., FDA, EMA, ISO).
   2. Enhanced Product Quality: Minimize the risk of equipment failure, data errors, and non-compliance, ensuring consistent product quality and safety.
   3. Operational Efficiency: Streamline operations with reliable and validated systems, reducing downtime and increasing productivity.
   4. Audit Readiness: Maintain thorough, well-documented validation records, ensuring readiness for regulatory inspections and audits.
   5. Data Integrity and Security: Safeguard the integrity of data and ensure secure management of critical pharmaceutical information.