GAMP® Validation Protocols for Efficient Documentation
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Documentation and IT , Risk Management & Controls , All FDA Regulated Functions , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Documentation and IT , Quality and Safety , Risk Management & Controls , All FDA Regulated Functions

Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Risk Management & Controls , All FDA Regulated Functions , Life Sciences , Documentation and Data Management

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
Category: All FDA Regulated Industry , FDA Audit and Inspection , FDA 21 CFR Part 11 , Documentation and IT , Audit & Inspection-Role , All FDA Reg. based Audit , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

How to Buy COTS Software, and Audit and Validate Vendors
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Laboratory Compliance , All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Laboratory , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Medical Device Inspection , Lab Audit , Drugs Inspections , Clinical Research Audit , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

HIPAA Compliance for Electronic Records
Category: HIPAA Compliance , Healthcare Compliance (Hospitals) , HEALTHCARE , Hospital Management , Audit & Data Security , HIPAA , IT Regulations , Healthcare Regulations , Audit & Inspection-Role , Healthcare Audit , Regulatory Affairs

21 CFR Part 11 and Annex 11 Compliance - Specifics Needed to Eliminate 483s
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , FDA 21 CFR Part 11 , Testing and Validation , Documentation and IT , Quality and Safety , Quality & Safety , Technologies and Processes , IT Regulations , Risk Management & Controls , All FDA Regulated Functions , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

The New Part 11 Inspections: Requirements for Validation and SaaS/Cloud Applications
Category: Drugs and Chemicals (Pharma) , Medical Devices , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , GXP Medical Devices , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Supply Chain and Manufacturing , Laboratory , Quality & Safety , Technologies and Processes , Drugs Regulations , Biotech Regulations , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

The 6 Most Common Problems in FDA Software Validation and Verification
Category: All FDA Regulated Industry