Automation
Validation of ERP System
Enterprise Resource Planning (ERP) system validation is essential in regulated industries, particularly pharmaceuticals, biotechnology, and medical devices, where ERP systems manage key operations like inventory, production, quality control, and distribution. Requirements Gathering User Requirements Specification (URS): Document what the users need from the ERP system, including both functional (what the ... Read More
Difference Between Industry 1.0, 2.0, 3.0 and 4.0
The main differences between the four industrial revolutions are the technologies used and the resulting impacts on manufacturing, the economy, and society: Industry 1.0The first industrial revolution began in the 1760s in England and used water and steam power to mechanize production. This led to more affordable and accessible goods. ... Read More
Re-Validation in Computerized System Validation (CSV)
In Computerized System Validation (CSV), revalidation refers to the process of re-assessing and re-qualifying a system after significant changes or events that may impact its validated state. It ensures that the system continues to operate as intended and in compliance with regulatory requirements. Revalidation is often required in the following ... Read More
Validation of a SCADA System Within CSV
Steps in SCADA (Supervisory Control and Data Acquisition) System Validation: Read also: Resource Person: Mohamed Mahmoud
How to Handle CSV in Pharmaceutical Industry
In the pharmaceutical industry, quality is not just an expectation; it’s a regulatory requirement. Computer System Validation (CSV) plays a critical role in ensuring that systems used to manage data and automate processes meet the necessary standards. For QA (Quality Assurance) professionals, overseeing CSV is essential for maintaining compliance and ... Read More
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