Validating spreadsheets: strategies for satisfying FDA requirements
Category: Risk Management , All FDA Regulated Industry , FDA Validation , Risk Management & Controls , All FDA Regulated Functions , Life Sciences

Spreadsheet Validation: Understanding and satisfying FDA requirements
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 , Life Sciences

21 CFR Part 11 compliance under the Obama administration
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies
Category: All FDA Regulated Industry , FDA Audit and Inspection , FDA Validation , Documentation and IT , Audit & Inspection-Role , All FDA Reg. based Audit , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

21 CFR Part 11 compliance for Electronic Medical Records
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Documentation and IT , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

The 6 Most Common Problems in FDA Software Validation and Verification
Category: All FDA Regulated Industry , FDA Validation , Documentation and IT , Life Sciences

Validation and use of Excel spreadsheets in FDA regulated environments
Category: All FDA Regulated Industry , FDA Validation , Documentation and IT , Documentation and Policy Management , Lifescience process & Procedures , Life Sciences

21CFR Part 11 - Predicate Rules Compliance
Category: All FDA Regulated Industry , FDA Validation , FDA 21 CFR Part 11 , Regulations & Guidances , Life Sciences , Regulatory Affairs , Common FDA Regulations

FDA's new enforcement initiative - Strategic Software Validation Planning for Executives and Managers
Category: All FDA Regulated Industry , FDA Validation , Documentation and IT , Life Sciences

GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters
Category: All FDA Regulated Industry , FDA Audit and Inspection , FDA Validation , Documentation and IT , Audit & Inspection-Role , All FDA Reg. based Audit , Life Sciences