Why ValidaPoint: Document

Control System Comparison

Why ValidaPoint: Document

Control System Comparison

Feature Comparison

Feature

Feature

Target Market

Target Market

Implementation Time

Implementation
Time

Customer Audit Ready

Customer Audit
Ready

21 CFR Part 11 Support

21 CFR Part 11
Support

EU GMP Annex 11 Support

EU GMP Annex
11 Support

Uses Existing Infrastructure

Uses Existing
Infrastructure

User Training Required

User Training
Required

Tamper-Evident Audit Trail

Tamper-Evident
Audit Trail

Electronic Signatures

Electronic
Signatures

Validation Templates

Validation
Templates

IT Resources Needed

IT Resources
Needed

Risk-Proportionate for Suppliers

Risk-
Proportionate
for Suppliers

ValidaPoint

ValidaPoint

Suppliers & small-mid pharma

Suppliers & small-mid
pharma

Suppliers &
small-mid
pharma

4-8 weeks

4-8 weeks

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Minimal

Minimal

Yes

Yes

Included

Included

Pre-built

Pre-built

Low

Low

Yes

Yes

Enterprise QMS

Enterprise
QMS

Large pharma manufacturers

Large
pharma
manufacturers

6-18 months

6-18 months

Yes

Yes

Yes

Yes

Yes

Yes

No

No

Extensive

Extensive

Yes

Yes

Often extra

Often extra

Custom

Custom

High

High

No

No

Manual SharePoint

Manual
SharePoint

Any organization

Any
organization

On going

On going

No

No

No

No

No

No

Partial

Partial

N/A

N/A

No

No

No

No

Manual

Manual

Medium

Medium

No

No

BG Overlay

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