The Problem

Pharmaceutical compliance challenges that delay launches

1

Development

ICH Q10 PQS spans the entire lifecycle

From development through commercialization to discontinuation, your pharmaceutical quality system must address every lifecycle stage. Verifying that documentation covers each element across every stage is a massive manual effort.

2

Pre-Inspection

Readiness takes weeks of preparation

When FDA or EMA announces an inspection, your quality team scrambles to review documentation, verify CAPA closures, and ensure knowledge management systems are current. The preparation itself becomes a full-time project.

3

Inspection

CMO and supplier systems are your responsibility

You're accountable for your contract manufacturers' and suppliers' quality systems. Verifying that a CMO's PQS meets ICH Q10 requirements means auditing their documentation — and you may have dozens of CMOs across multiple geographies.

4

Recovery

Knowledge management and CAPA gaps

ICH Q10 emphasizes knowledge management and CAPA effectiveness — areas where documentation gaps are hard to find through manual review. Process interactions between departments create blind spots that inspectors find.

Standards Coverage

ICH Q10 — pharmaceutical quality system analysis

Full element coverage with lifecycle-stage awareness

Management Responsibility

Quality policy, resource management, internal communication, management review, and outsourced activities oversight

Continual Improvement

CAPA system, process performance monitoring, product quality monitoring, and change management across the lifecycle

Process Performance Monitoring

In-process controls, analytical methods, and statistical process monitoring to ensure consistent product quality

Knowledge Management

Product and process knowledge acquisition, protection, transfer, and retention throughout the product lifecycle

FDA 21 CFR Part 211

Current Good Manufacturing Practice for pharmaceuticals — coming soon

Audit your CMOs and supplier network at scale

In pharma, you're accountable for every link in your supply chain. Whether it's a contract manufacturer producing your API, a packaging supplier, or a testing laboratory, their quality system gaps become your inspection findings. Aligntra lets you upload a CMO's quality documentation and get the same depth of ICH Q10 analysis you run on your own PQS. Verify compliance across your entire supplier network without scheduling site visits or hiring additional auditors. When the inspector asks how you qualify your CMOs, show them the data.

Use Cases

How pharmaceutical teams use Aligntra

Quality Manager

"Before contracting a new CMO or qualifying a supplier, I upload their quality documentation. I get an ICH Q10 compliance report showing exactly where their pharmaceutical quality system meets requirements and where it doesn't. Qualification decisions based on evidence, not audit checklists."

CMO Auditor

"I upload our PQS documentation before an FDA or EMA inspection. I get a clear picture of which ICH Q10 elements are covered, which have gaps, and which supporting evidence exists. I focus preparation time on the areas that matter most."

Regulatory Affairs

"I verify that our CAPA records follow documented procedures. Aligntra checks timelines, required fields, and evidence of effectiveness — ensuring our corrective actions actually address root causes across the product lifecycle."

Manufacturing Lead

"ICH Q10 applies differently across development, technology transfer, commercial manufacturing, and discontinuation. I analyze documentation with lifecycle context to ensure each stage has appropriate quality system coverage."

Platform Features

Built for pharmaceutical compliance

Evidence traceability across PQS documentation

Every finding links to the exact page and paragraph in your source documents. Click any citation to see it highlighted in the built-in PDF viewer. Provide inspectors with traceable evidence for every ICH Q10 element.

Lifecycle-stage awareness

Analysis accounts for ICH Q10's lifecycle approach — development, technology transfer, commercial manufacturing, and product discontinuation. Findings are contextualized to the relevant stage of your product's lifecycle.

Gap consolidation

AI-powered deduplication reduces redundant findings by 70-80%. Complex pharmaceutical quality systems generate hundreds of potential gaps — consolidation gives you actionable findings, not noise.

Audit-ready exports

Export findings to Excel or PDF with full evidence citations. Present compliance status to inspectors, quality leadership, or partner companies with data they can verify independently.

Pharmaceutical QMS Compliance — ICH Q10 Gap Analysis Software