COMPUTERIZED SYSTEM VALIDATION

Computerized System Validation (CSV) ensures that computer systems used in regulated environments operate accurately, reliably, and in compliance with industry standards.

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Arizona Provides the Following Full Validation Services

Process Control System Validation

PLC/ HMI/ IPC/ SCADA/ DCA System Validation

Laboratory Software Validation

HPLC, GC, FTIR, Spectrometer, EMPOWER, UV, LCMS-MS, Chromeleon, SAS, WinOnlin & more

Enterprise Software Validation

SaaS, SAP, ERP, MES, LIMS, TMS, QMS, E-DMS

Building Management System (BMS)

Environment Management System (EMS) Validation

Infrastructure Qualification

Cloud, Server, Network Validation, Meta Data Qualification, Desktop Validation

Aggregation / Serialization

Track & Trace, TracLINK, ReeTrak, L1 to L5 Integration Validation, Warehouse Management Software Validation

Equipment Qualification (IQ, OQ, PQ)

Excel Sheet Validation (CFR Title 21 Part 11)

Customized Software Validation

Audit Support

CSV Audit and CSV Training

Computerized system validation framework to achieve and maintain GxP compliance throughout the computerized system life cycle.

Validation plans and reports provide a disciplined and consistent approach to meeting regulatory requirements.

Validation of systems to ensure accuracy, reliability, and the ability to discern invalid or altered records. (Ref.: 21 CFR 11.10 (a))

A computerized system includes hardware, software, network components, and controlled functions. (Ref.: ISPE GAMP5)

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CSV VALIDATION DELIVERABLES

  1. GxP Assessment and System Categorization
  2. Validation Plan
  3. User Requirement Specifications
  4. Risk Assessment
  5. Functional Design Specification
  6. Installation Qualification
  7. Operational Qualification
  8. Performance Qualification
  9. Validation Summary Report
  10. Traceability Matrix
  11. System Release Certificate
  12. Periodic Review Report
  1. Assessment of: GAP, GXP, Title 21

Applicable Industries

  1. Human & Veterinary
  2. Pharmaceuticals
  3. APIs
  4. Biologics
  5. Biotechnology
  6. Blood Products
  7. Medicinal Gases
  8. Medical Devices

📘 Computerized System Validation Guide 📘

1. Validation Approaches:

  • Risk-based approach
  • Life cycle-based approach
  • “V”-model for development and system testing
  • Process-based approach
  • GAMP category system approach

2. Regulatory Guidelines:

Identifying regulatory frameworks (NOM / FDA / WHO) before validating system requirements.

Aligning validation with Quality Management Systems (QMS) of each organization.






3. Business Functions Involved:

Designed for use regardless of validation knowledge, covering:

  • Administration
  • Quality Unit
  • Investigation
  • Development
  • Manufacturing
  • Laboratory
  • Engineering
  • Maintenance
  • Regulatory Affairs
  • Human Resources
  • IT
  • Support Staff
  • Associated Suppliers

CSV Regulatory Requirements​

➠ FDA 21 CFR 11 Electronic Record ; Electronic Signatures​.

- Subpart B—Electronic Records, Sec. 11.10​.

➠ Controls for closed systems.​​

- Such procedures and controls shall include the following.

➠ Validation of systems. ​​

- to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.​

➠ FDA 21 CFR 820 Quality system Regulation​.

- Subpart Design Controls, Sec. 820.30(g)​

- Design validation shall include software validation and risk analysis, where appropriate ​​Subpart G Production and Process Controls , Sec 820 .70 (i)​

- When Computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. ​

➠ FDA 21 CFR 211 Current Good Manufacturing Practice for Finished Pharmaceuticals​

- Subpart D—Equipment , Sec. 211.68(b)​

➠ Input to and Output from the Computer​​

- or related system of formulas or other records or data shall be checked for accuracy.​

➠ EC Council Directive 93/42/EEC​ ANNEX 1 Essential Requirements

- 12.1a For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of art taking into account the principles of development lifecycle, risk management, validation and verification.​

➠ The application should be validated; IT infrastructure should be qualified.

- EudraLex Volume 4 ​Good Manufacturing Practice, Medicinal Products for Human and Veterinary use ​Annex 11 Computerized Systems

➠ ICH Q7A, Good Manufacturing Practices for Active Pharmaceutical Ingredients

- GMP related computerized system should be validated. The depth and scope of validation depends on the diversity, Complexity and criticality of the computerized application.

➠ ICH E6 Good Clinical Practice

- When using electronic trial data handling and / or remote electronic trial data systems, The sponsor should:

- Ensure and Document that the electronic data processing system (s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e. validation)​

➠ PIC/S PE 005-3 GMP Guide for Blood Establishment

- 9.8 The hardware and software of the computers should be checked regularly to ensure reliability. The Software (Program) should be validated before use.​

➠ PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products

- Before a computerized system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, Consistently and reproducibly. ​

➠ PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products

- Before a computerized system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, Consistently and reproducibly. ​

➠ PIC/S PE 011-1 Guide to Good Distribution Practice for Medicinal Products

- Before a computerized system is brought into use, it should be demonstrated, through appropriate validation or verification studies, that the system is capable of achieving the desired results accurately, Consistently and reproducibly. ​

Achievements