Draft, Execute and Approve GxP Documents in Word
Regulated Document Completion System
01

Pre-Approve

Open any of your Word Documents. Use the Add-in to Sign and invite approvers.
02

Execute

Fill out the Word tables (execution) and add attachments using the side task pane.
03

Post-Approve

Mark and assign corrections and clarifications without leaving your desk.
04

Auto-Archive

Automatic Signature & Attachment Logs and file archiving in your GxP Library.

Digital GxP Compliance

21 CFR Part 11

Electronic Records, Electronic Signatures

GAMP5

Good Automated Manufacturing Practice

ALCOA++

Attributable | Legible | Contemporary | Original | Accurate

DI

Data Integrity

CSA

Computer Software Assurance

CSV

Computer System Validation

GRK

Good RecordKeeping Practice

Features

Sign, type data entries, attach files and approve any GxP Record (Batch Records, Validation Protocols, Logbooks etc.) in MS Word.

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