
What is a 21 CFR Part 11 Compliant Document Management System?
A 21 CFR Part 11 compliant document management system (DMS) is a digital infrastructure designed to meet the FDA’s strict requirements for handling electronic records

A 21 CFR Part 11 compliant document management system (DMS) is a digital infrastructure designed to meet the FDA’s strict requirements for handling electronic records

If you have ever felt overwhelmed by the mountain of paperwork and regulations in the life sciences industry, well, you are not alone. The life

The field of healthcare technology is always changing, and as such, the need for comprehensive regulations around Software as a Medical Device (SaMD) is on

Document control is a fundamental requirement for regulatory compliance, quality control, and operational effectiveness in the highly regulated field in which device developers operate. Medical device

DMS in a layperson perception A clear and straightforward explanation of the Document Management System (DMS) can help us grasp the effectiveness of this digital

The pharmaceutical industry operates in a highly regulated and complex environment, facing numerous challenges that can impact productivity, compliance, and overall efficiency. Managing documents from

Go Paperless with Document Management System Gone are the days when we used to keep all our essential information and crucial data in tones of

Maintaining strict quality standards, efficient processes, and compliance with regulatory requirements is paramount in the highly regulated and complex pharmaceutical industry. Document management plays a

In the pharmaceutical industry, data integrity is paramount to ensuring the safety, efficacy, and quality of medications. The term “data integrity” refers to the accuracy,

Incorporating digital technologies in the life sciences industry has become a business necessity in recent times. With daily regulatory updates, increasing documentation, and the need
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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 Surveillance Management System
Continued Process Verification