QMS documentation discussed in this article are documents and records related to compliance and quality assurance. These documents define the company’s Quality Management System (QMS). The QMS documentation is defined by each company based on regulatory and...
Standard Operating Procedure (SOP) is a document that provides directions on how tasks and processes should be carried out within a company. Standard Operating Procedures (SOPs) are an integral part of the routine operations in the pharmaceutical industry, and every...
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals, namely data integrity, comprehensive audit trails, limited system access, trained users, and more. However, there are notable differences between these regulations....
A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Various standards and regulations outline specific requirements for...
The ICH Q10 Pharmaceutical Quality System (PQS) is a guideline that outlines a model for an effective quality management system for the pharmaceutical industry. ICH Q10 provides a comprehensive model based on the International Standards Organization (ISO) quality...
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