Decision Documentation Assessment
Identify where a completed decision becomes hard to explain and where reconstruction exposure exists.
Start the DDADecision visibility
Start with the question your organization needs to answer now—not with a generic software tier.
Identify where a completed decision becomes hard to explain and where reconstruction exposure exists.
Start the DDACreate a reviewer-ready record of evidence, judgment, risk, alternatives, and authorization for one completed consequential GMP decision.
$497 · one completed GMP decision Create an IRR — $497Use when the decision exposure is broader, active, or not yet clear enough to route to a single self-service product.
Request an executive briefingDecision-record coverage
Start with one IRR for $497. When every consequential decision needs a record, Decision Coverage includes a set number of Inspection Response Records each month. Plans renew automatically until you cancel.
Start with the decision in front of you. Buy a single IRR and start Decision Coverage within 30 days, and we credit $497 toward your first month.
Start with one decision
Recommended starting point$4971 consequential decision
Create one complete record of the evidence, judgment, risk, authorization, and timing behind one current consequential decision.
A single batch release, CAPA closure, deviation disposition, change control, validation conclusion, or inspection response that needs to stand on its own.
Recurring decision coverage
$999per month · 3 Included Records each month
Included Records are added at the start of each month. Unused records carry over while your Coverage is active.
A recurring mix of CAPA, batch-release, deviation, change-control, validation, or inspection-response decisions.
Broader recurring coverage
$2,500per month · 8 Included Records each month
For teams with a larger flow of consequential decisions across decision types, products, or quality processes.
Quality teams that need a record behind every consequential decision as it is made.
Extend organizational coverage
Organization plans are set in a written order form and governed by it.
Written order form
Coverage renews automatically each month until you cancel. Cancellation takes effect at the end of the current Billing Period. See Terms, Section 19. Looking for Case Files? See the Case Files →
What one IRR preserves
What was known and which records informed the decision.
How the available information was evaluated.
What uncertainty and residual exposure were weighed.
Who accepted the decision and why.
A completed IRR makes one consequential decision independently understandable and reviewable.
See a completed Inspection Response Record →Pricing FAQ
No. ComplianceWorxs is organized around the consequential decisions your organization needs to preserve. The starting unit is one Inspection Response Record for one decision.
Use an additional IRR when another consequential decision needs to be independently understandable and defensible. Examples may include batch release, CAPA closure, deviation disposition, change control, validation conclusions, and inspection responses.
No. Use an IRR where the decision is consequential enough that the organization may need to show what was known, how the conclusion was reached, what risk remained, and who had authority to accept it.
Decision Coverage is a recurring plan that includes a set number of Inspection Response Records for each month. Individual is $999 per month with 3 Included Records. Team is $2,500 per month with 8 Included Records.
Yes, while your Coverage is active. Included Records are added at the start of each month. Unused records expire when your Coverage ends, have no cash value, and cannot be transferred.
Cancel at any time from your billing portal or by emailing support@complianceworxs.com. Cancellation takes effect at the end of the current Billing Period, and there is no fee to cancel.
Yes. If you buy a single Inspection Response Record and start Decision Coverage within 30 days of that purchase, we credit $497 toward your first month. The credit applies once per customer and is applied through a promotion code we provide.
Organization plans are set in a written order form and governed by it. They are for needs beyond Individual and Team, especially where multiple teams, sites, or recurring decision types are involved.
When a completed IRR shows that earlier reasoning must be reconstructed or strengthened, ComplianceWorxs identifies the appropriate next step, including the Decision Record path where applicable.
Start with one decision
Begin with one Inspection Response Record. Expand decision-record coverage as more decisions need to stand up to review.