Automation
Computer System Validation in Pharmaceutical Industry
CSV is the process of testing/validating/qualifying regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper-based records. The validation process begins with planning, system requirements definition, testing and verification activities, ... Read More
Predictive Maintenance and Machine Learning in GMP Facilities
Predictive maintenance (PdM) is a general method that uses ongoing analysis of operational data to determine when equipment maintenance will be required. When applied appropriately, it can reduce maintenance expenses while improving reliability. Maintenance of GMP facilities is necessary to ensure that they operate in a qualified and validated state ... Read More
Benefits of Pharma 4.0
Pharmaceutical manufacturers face many unique challenges in this remarkable era. While technological advancements have multiplied opportunities for process improvements, regulatory oversight has allowed adoption compared to other industries. There are stringent requirements for documentation, process validation, and data integrity to create an environment where compliance outweighs continuous improvement. Pharma 4.0 ... Read More
Top Trends of Pharma 4.0
Faster production The pharmaceutical industry is shifting from producing drugs for the masses to high-value treatments. Manufacturing life savingdrugs in low volumes complicates the manufacturing process as the latter is just as rigorous and time-consuming as the mass production workflows. Low volume production faces challenges because there are fewer batches ... Read More
GxP Compliance Checklist | 5 Ps
GxP is a bunch of quality guidelines and benchmarks designed to ensure that your products are safe for patient use and adhere to quality standards consistently. GxP applies most readily to pharmaceutical and biopharmaceutical organizations through the requirements of USFDA 21 CFR Part 210 – 211. List of GxP Compliance ... Read More
GXP Compliance | The Future of Validation
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to disruptive innovation, from batch to continuous processing, from bulk processing to personalized medicine, from centralized systems to the ... Read More
Executing Efficient and Effective CSV Audits
Once planning is complete, it’s time to execute the actual CSV audit. Here are some tips for conducting rigorous, value-adding CSV audits: Interview StakeholdersDiscuss in-depth with stakeholders like system owners, quality managers, and end users. This provides insights into how systems are used and any issues. Examine DocumentationThoroughly review all ... Read More
Computerized System Validation (CSV) Audits
Computerised system validation (CSV) is critical in regulated industries like pharmaceuticals, medical devices, and biotech. It ensures that computerised systems are compliant with guidelines and capable of consistently producing high-quality products and data. A key component of the CSV process is CSV auditing. CSV audits examine and evaluate computerised systems ... Read More
Difference Between CSV and CSA
Definition Computer system validation (CSV) is the process of ensuring that a computer system meets its intended use and performs as expected, while computer system/software assurance (CSA) is the process of ensuring that a computer system is secure, reliable, and available. Purpose The purpose of CSV is to ensure that ... Read More