Blog

Remote Auditing Worldwide

Desiree Tarranco

Remote Auditing Best Practices (for Auditors and Auditees)

Audits

Illustration of an Electronic Quality Management System

Desiree Tarranco

Electronic Quality Management System (eQMS)

QMS

FDA 21 CFR Part 11 - Electronic Signature - Electronic Records - Requirements

Desiree Tarranco

FDA 21 CFR Part 11: Definition, Compliance Requirements, Benefits, and Software

21 CFR Part 11

Post-Market Surveillance Data Analysis

Desiree Tarranco

Medical Device Post-Market Surveillance (PMS)

Medical DevicesPost-Market Surveillance

DHF vs. DMR vs. DHR: Differences and Relations

Desiree Tarranco

DHF vs. DMR vs. DHR: Differences and Relations

Medical Devices

Woman Standing and Analyzing Record

Desiree Tarranco

Device History Record (DHR): Definition, Requirements, and What It Includes

Medical Devices

Device Master Record (DMR) Illustration

Desiree Tarranco

Device Master Record (DMR): Definition, Requirements, and What It Includes

Medical Devices

Design History File (DHF) Illustration

Desiree Tarranco

Design History File (DHF): Definition and Requirements

Medical Devices

Design controls for medical device

Desiree Tarranco

Design Controls: Definition, Requirements, Process, and Phases

Medical Devices

Man Next to a Document Folder

Desiree Tarranco

Medical Device Document Control: Definition, Process, and Requirements

Document ControlMedical Devices

Illustration of a Woman Holding Documents

Desiree Tarranco

Pharmaceutical Document Management: Definition, Requirements, and Software

Document ControlPharmaceutical

Laboratory document management

Bruna De Lucca Caetano

Lab Document Management: Definition, Types, Requirements

Document ControlLaboratory