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21 CFR Part 11 is the FDA guideline defines the criteria under which electronic records and electronic signatures considered to be trustworthy, reliable and equivalent to paper records. Part 11, as it is commonly known and was introduced in 1997, applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of electronic records and application of electronic signatures to them.

What is QMS (Quality Management System) Software? QMS Management qms system

Change management system helps you in managing change requests in business processes ensuring constant improvement of the organization change management system

What is an EDMS or Electronic Document Management System? An EDMS or Electronic Document Management System is a software lets you create, edit, process, revise, and store documents in text, images, video, and audio files with scanning and printing features. edms

What is ISO 9001 compliance and ISO 9001 implementation? ISO 9001 compliance ensures an organization is adhering to the latest requirements of ISO standards. ISO 9001 implementation drives operational excellence. iso 9001 implementation

Health and Safety Incident Management Software Solution for enterprises Safety Incident Management software to help centralize all your incident data, near misses, and safety observations and fulfill CAPA and OSHA regulations. safety incident software

Understanding FDA Training And Compliance Regulatory Training description: The FDA training and compliance regulatory training is designed with multiple training tools to assist international and domestic industrial professionals with FDA regulations. fda training

CAPA Management Software to Identify, Analyze and Prevent risks description: CAPA management software enables you to identify and investigate non-conformance and discrepancies caused in a system for a faster rectification of problem. corrective action software

Best cloud-based highly recommended and rated QMS Software ComplianceQuest QMS Software is 100% cloud-based best QMS software which is highly recommended and rated by top quality management experts. Compare why cheap QMS Software compared to others. best quality management solution

Supplier Management Solutions to increase supplier performance Supplier Management Solutions is an advanced holistic approach to streamline the complete supply chain lifecycle by integrating quality, safety, performance management and collaboration tools. supplier management solutions

What is CAPA - Corrective and Preventive Action? CAPA or Corrective and Preventive Action is a way to improve the company’s processes by taking a series of actions that eliminate the recurring events and causes of non-conformities. capa quality management system