
Software as a Medical Device (SaMD): Technical File Requirements
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
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
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 new-age technology in Lifesciences: With the new digital innovations happening every day, every industrial sector, including pharma and life sciences companies, has witnessed remarkable
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
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
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
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