
What to expect during an ISO 9001 Audit?
In the pharmaceutical world, quality is paramount: it governs everything from research and production to patient care. Audits play an important role in this process;
In the pharmaceutical world, quality is paramount: it governs everything from research and production to patient care. Audits play an important role in this process;
Managing Out of Specification (OOS) results in medical device manufacturing is very important for quality, regulatory compliance, and patient safety. The FDA and MHRA stress a
Stability studies are a crucial aspect of pharmaceutical development, ensuring that a drug product maintains its identity, strength, quality, and purity over time under specified
Managing deviations effectively is critical for organizations aiming to maintain operational excellence and regulatory compliance. While traditional software solutions help streamline the process, there’s always
Changing processes in the pharmaceutical industry undergoes a long and redundant change control method. By industry definitions, change control is the systematic way by which
The pharmaceutical industry, a critical healthcare innovation and delivery sector, relies heavily on digital transformation for research, patient care, and business operations. This rapid digitization
Annual Product Quality Review
Electronic
Logbook System
Laboratory Information Management System
Manufacturing Execution System
Calibration & Preventive Maintenance
Regulatory Information Management System
Learning Management System
Environmental Monitoring System
Electronic Quality Management System
User Access Management System
Document Management System
Quality Control
System
Cleaning Validation Software
Process Validation
Software
Regulatory Scheduling Management System