Skip to content

Watch It Work

14 Seconds from Compliance Video to Audit Evidence

See how compliance training becomes FDA-compliant audit documentation instantly

Trusted by Leading Organizations

Join forward-thinking teams using Docsie to transform video content into searchable documentation

Fellowmind
Becklar
PowerFlex
North Highland
AddSecure
Canada

Recognized on G2

Auditors Won't Watch 40 Hours of Training Videos

FDA/ISO audits require documentation, not video files

The Compliance Training Video Problem

  • Auditors won't watch 40+ hours of training videos during site visits
  • Videos don't meet FDA CFR 21 Part 11 documentation requirements
  • No way to search for specific regulations or SOPs in videos
  • Can't prove training coverage of required topics
  • No audit trail showing what was trained and when
Recommended

The Docsie Solution for Compliance

  • Generate audit-ready training documentation auditors can review
  • FDA-compliant format with version control and electronic signatures
  • Searchable by regulation (CFR 21 Part 11, ISO 13485, GxP)
  • Timestamped proof of content coverage for audit defense
  • Permanent audit trail with document history and change control

FDA/ISO Compliance Features

Built for Regulated Industries

Docsie generates compliant training documentation that meets FDA CFR 21 Part 11, ISO 13485, and GxP requirements—with audit trails, version control, and electronic signatures.

FDA CFR 21 Part 11 Compliance

Electronic signatures, audit trails, and document control that meet FDA requirements for pharmaceutical and medical device training documentation

Regulation-Indexed Documentation

Auto-tag content by regulation (CFR 21 Part 11, ISO 13485, GxP, HIPAA). Auditors can search for specific compliance topics instantly

Version Control & Change History

Complete document history showing what changed, who changed it, and when. Meets ISO/FDA requirements for document control and change management

Simple Process

From Compliance Training to FDA Audit Evidence in 3 Steps

Powered by Docsie Copilot's compliance-aware AI

1
Upload Compliance Training

Upload Compliance Training

Upload GMP training, SOP videos, or regulatory training from your LMS. Supports FDA-validated file formats

2
AI Generates Audit Documentation

AI Generates Audit Documentation

AI maps training to FDA/ISO regulations, creates version-controlled documentation with audit trails and electronic signature readiness

3
Export Audit Evidence

Export Audit Evidence

Get FDA CFR 21 Part 11-compliant documentation with audit trails, training completion records, and regulation references

FDA/ISO Compliance Documentation in Action

See how pharmaceutical and medical device companies convert training to audit evidence

Convert GMP Training to FDA Audit Documentation
FDA Audits

Convert GMP Training to FDA Audit Documentation

Transform Good Manufacturing Practice training into FDA CFR 21 Part 11-compliant documentation with electronic signatures, audit trails, and version control. Auditors get searchable evidence of employee training on manufacturing procedures and quality controls.

  • 4-hour GMP training → FDA-compliant documentation with audit trail
  • Automatic tagging to CFR 21 Part 11 and GMP requirements
  • Electronic signature workflow for training completion
Turn Medical Device Training into ISO Audit Evidence
ISO 13485

Turn Medical Device Training into ISO Audit Evidence

Convert design control, risk management, and CAPA training into ISO 13485-compliant documentation for medical device audits. Structured documentation with version control and training competency records.

  • ISO 13485 training → documentation mapped to quality system procedures
  • Automatic linkage to design controls and risk management requirements
  • Training records for notified body and FDA inspections
Transform GxP Training into Regulatory Audit Documentation
GxP Compliance

Transform GxP Training into Regulatory Audit Documentation

Convert Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) training into audit-ready documentation with regulatory traceability and training effectiveness evidence.

  • 3-hour GxP training → searchable documentation by GxP requirement
  • Automatic extraction of critical process steps and compliance requirements
  • Training completion evidence for regulatory inspections

What You Get from Compliance Training Videos

Audit-ready deliverables from compliance training footage

FDA CFR 21 Part 11-Compliant Documentation

Training documentation with electronic signature readiness, audit trails, and version control that meets FDA requirements for pharmaceutical and medical device industries

Regulation-Tagged Content

Training content automatically tagged to FDA regulations (CFR 21 Part 11, GMP), ISO standards (13485, 9001), and GxP requirements for instant audit evidence retrieval

Audit Trail & Version History

Complete change history showing who trained, what changed, when it changed—with document control meeting FDA/ISO requirements for training record management

Training Completion Records

Employee training certificates with documented proof of GMP, GxP, or ISO training completion—timestamped records for regulatory inspections and audits

Searchable by Regulation & SOP

Find training on specific FDA regulations, SOPs, or quality procedures instantly—auditors search "CFR 21 Part 11" and get all related training documentation

Training Competency Matrix

Documentation organized by role and competency requirement—quality engineers get GMP docs, lab staff get GLP training, production staff get manufacturing procedures

Product Demo

See Docsie Convert Compliance Training to FDA Audit Evidence

Watch how Docsie analyzes GMP training videos and generates FDA CFR 21 Part 11-compliant documentation with audit trails and regulation mapping

No credit card required • 14-day free trial

Common Questions

Compliance Training to Audit Evidence FAQ

Everything you need to know about converting compliance training to audit-ready documentation

FDA & ISO Compliance

Most Popular

Q: Does this meet FDA CFR 21 Part 11 requirements for training documentation?

A: Yes. Docsie generates documentation with audit trails, version control, and electronic signature readiness that supports FDA CFR 21 Part 11 requirements. The system maintains complete change history and creates documented evidence of training completion for regulatory submissions.

Q: Can auditors use this documentation instead of watching training videos?

A: Yes. Auditors get searchable text documentation with timestamps, version history, and content traceability—not 40 hours of training videos. They can search for specific regulations, SOPs, or compliance topics and find relevant training evidence instantly.

Q: How does this help with ISO 13485 and IATF 16949 audits?

A: Docsie converts training videos into documentation that meets ISO quality management requirements. The system creates structured training records with audit trails, links to procedures, and evidence of training effectiveness—exactly what auditors expect to see.

Audit Readiness

Q: Can I tag documentation by regulation (CFR 21, ISO 13485, GxP)?

A: Yes. Docsie automatically identifies regulatory references in training content and tags documentation by regulation. Auditors search 'CFR 21 Part 11' and find all related training documentation instantly—no manual tagging required.

Q: How does version control work for compliance documentation?

A: Every change is tracked with who made it, when, and what changed. You get complete document history that meets FDA and ISO requirements for document control—essential for proving training content hasn't been improperly modified.

Still have questions?

Book a Demo

Supported Video Formats

Compatible with major video platforms and formats

YouTube logo

YouTube

Process YouTube videos and playlists

Vimeo logo

Vimeo

Convert Vimeo content

Standard Formats

Support for MP4, AVI, WebM, MOV

Ready to Transform Your Documentation?

Start creating professional documentation that your users will love