CSV for Dummies- Part 3 Where is CSV used?

In the vast landscape of regulated industries, Computer System Validation (CSV) plays a crucial role in ensuring the integrity, safety, and effectiveness of products.

Today, Let's explore 3 aspects of CSV:

1 ) What all industries does CSV apply?

2) What is the History of CSV in these industries?

3) What Regulations apply in CSV?

1 ) What all industries does CSV apply?

1. Pharmaceutical Industries (Human and Veterinary):

• Validation of computerized systems is integral for pharmaceutical processes, ensuring reliability and compliance with Good Manufacturing Practices (GMP).

2. Pharmaceutical Chemicals :

• CSV extends to the validation of systems involved in the production of pharmaceutical chemicals, maintaining data accuracy and integrity.

3. Biologics and Biotechnology:

• For industries dealing with biologics and biotechnology, CSV is indispensable in verifying the functionality and reliability of computerized systems.

4. Blood Products and Gas Medicinal Products:

• CSV ensures that computerized systems associated with blood products and medicinal gases adhere to stringent quality and safety standards.

5. Medical Devices:

• The validation process extends to computerized systems used in the production and support of medical devices, promoting reliability and compliance.

CSV finds application in various Good Practices (GxP) activities, including:

• Manufacturing / Production (GMP):Validating systems used in manufacturing processes to ensure consistent product quality and compliance.
• Clinics (GCP):Applying CSV in clinical settings to maintain the accuracy and reliability of electronic systems used in trials and patient-related activities.
• Laboratory (GLP):Ensuring the reliability of laboratory informatics systems (LIMS, ELN) to guarantee product safety.
• Good Distribution Practices (GDP):Validating systems involved in distribution processes, safeguarding the quality and integrity of products during transportation.
• Storage (GWP):Implementing CSV in storage systems to preserve the quality and safety of pharmaceutical products.
• Documentation (GDP):Validating systems related to documentation processes, securing accurate and reliable record-keeping.

CSV in Laboratory Informatics:

• CSV becomes essential for laboratory informatics systems, including LIMS, ELN, and CDS, ensuring the safety of products for consumers.

Regulatory Landscape:

• Regulatory bodies, such as the FDA in the United States, mandate CSV for industries impacting consumer health. The Code of Federal Regulations (CFR), especially 21 CFR Part 11, outlines requirements for electronic records and signatures.

Clinical Trials:

• In clinical trials, CSV is paramount for electronic systems involved in various tasks, ensuring data accuracy, reliability, and security to uphold patient safety and regulatory compliance.

2) What is the History of CSV in these industries?

Historical Evolution and Regulatory Framework:

• The journey of CSV began in the 1970s, with the FDA recognizing its importance. Over the decades, regulatory frameworks like 21 CFR Part 11, GxP guidelines, and ISO 13485 have shaped CSV practices.

Modern Challenges:

• In the 21st century, advancements like cloud computing and artificial intelligence present new challenges for CSV, necessitating continual adaptation to emerging technologies.

3) What Regulations apply in CSV?

• Title 21 CFR Part 11(.10)
• 21 CFR Part 820(.70)
• Annex 11 to the EU GMP
• GxP (Good Practice) Guidelines
• ISO 13485 We will go into details of each of the regulations in future parts of this newsletter. So stay tuned.

4) What does it not apply?

Certain software components, such as commercial operating systems like Windows, Unix, and Linux, serve as foundational infrastructure necessary for proper application functioning. While not directly subjected to validation, these systems undergo extensive testing and verification during their development by the respective companies.

Another instance is antivirus and firewall software, which, similar to the aforementioned example, undergo rigorous pre-release testing. Constant development addresses emerging threats, requiring regular updates to shield companies from malicious agents.

Conclusion:

By embracing CSV principles, researchers ensure that computerized systems meet the highest standards of accuracy, reliability, and integrity. The return to the original spirit of GAMP 5 emphasizes fitness for use, baseline compliance, and managing residual risks—a commitment to quality and patient well-being.

Keep an eye out for Part 4, where we explore HOW to do CSV?

See you next week.

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