QA Stack

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eQMS Software for Pharma — Deviations, CAPA, Change Control & Audits

A pharma-specific Quality Management System built for QA teams managing deviations, CAPAs, change controls, OOS investigations, and inspection readiness. Compliant with 21 CFR Part 11, WHO-GMP, and CDSCO Schedule M. Can be deployed standalone or connected to your DMS or eBMR.

Deviations & CAPAChange ControlRisk RegisterOOS / OOTAudits & InspectionsTraining Management

Why teams choose QA Stack eQMS

  • Faster investigations: Root cause workflows and CAPA tracking reduce cycle time.
  • Audit-ready evidence: Complete digital audit trails simplify regulatory inspections.
  • Connected quality: Integrates with DMS and eBMR to reduce manual handoffs.
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Quality Sub-Modules

FDA 21 CFR Part 11 Compliant Quality Workflows

Stop putting out the same fires.

When a deviation occurs on the shop floor, the clock starts. QA Stack digitizes the entire event logging, root cause analysis (RCA), and CAPA initiation process so nothing falls through the cracks.

Step 01

Event Logging

Shop-floor operators log deviation details with containment actions.

Evaluate risk before you execute.

Whether you are updating an SOP, changing a supplier, or modifying equipment, QA Stack forces cross-functional impact assessments. The integrated Risk Register ensures ICH Q9 principles are applied automatically.

Step 01

Change Proposal

Proposed changes to SOPs, equipment, or materials are initiated.

Defend your laboratory investigations.

OOS results are the #1 target for FDA 483 observations. QA Stack enforces strict Phase I and Phase II investigation protocols, preventing undocumented re-testing and ensuring proper batch disposition.

Step 01

OOS Result

Laboratory analyst records a test result falling outside specification limits.

Always audit-ready. Always qualified.

Manage internal, external, and supplier audits in a centralized hub. Automatically trigger training requirements when CAPAs or Change Controls result in new SOP revisions, ensuring shop floor operators are always qualified.

Step 01

Audit Plan

Annual scheduling and scope planning for internal and supplier audits.

Process Orchestration

Closed-Loop Quality Workflows

In a regulated GxP environment, workflows cannot exist in silos. Every deviation logged on the shop floor feeds directly into our corrective action and preventive action (CAPA) loop.

Closed the Loop. Drive Continuous Quality.

From deviation to CAPA resolution and effectiveness check — every step is connected, traceable and audit-ready.

Built for Compliance.
21 CFR Part 11 Compliant
Audit Trails
Electronic Signatures
Data Integrity
GxP Validated

Integrated Root Cause Analysis (RCA)

Instead of managing investigations in document attachments, QA Stack provides native, search-engine-readable RCA templates directly inside deviation forms, allowing operators to visually link failure points to process boundaries.

Manpower (Operator)
SOP training qualification lapse
Dual-signature witness validation bypass
Machine (Equipment)
Autoclave temperature sensor drift (cal. error)
Validation calibration date threshold exceeded
DEVIATION EVENT EFFECT
Method (Procedure)
Exceeded maximum mixing duration boundary
Ambient cleanroom humidity outside process limits
Material (Supply Chain)
Excipient raw lot purity variance from vendor
LIMS raw material release hold delay override
Data Architecture

GxP-Compliant Data Architecture & Safety

QA Stack handles critical pharmaceutical operations data. Our database structure is engineered to exceed global compliance expectations for security, auditability, and validation lifecycle stability.

Immutable SQL Audit Trail

Every create, read, update, and delete (CRUD) event is logged at the database layer with RFC 3161 tamper-evident cryptographic timestamps. Data fields are locked (`__locked: true`) post-signature.

Database Isolation Modes

Choose between logically partitioned multi-tenant configurations (ideal for fast setups) and completely isolated single-tenant dedicated databases mapping to GxP virtual private clouds (VPCs).

Bidirectional REST API Integration

Natively synchronize GxP events with enterprise resource planning (ERP) suites like SAP and Oracle, as well as chromatography LIMS platforms, ensuring data integrity across validation systems.

GAMP 5 Validation Ready

Designed as GAMP 5 Category 4 configured software. Provided with a full validation lifecycle documentation suite (URS, FS, IQ/OQ templates, trace matrices) to slash internal testing overhead.

Regulatory Alignment

FDA 21 CFR Part 11 & GxP Compliance Matrix

FDA 21 CFR Clause / GxP RuleRegulatory RequirementQA Stack eQMS Implementation Solution
11.10(a)Validation of systems to ensure accuracy, reliability, and consistent performance.
Provided with complete validation documentation (IQ/OQ/PQ protocols) and pre-packaged GAMP 5 automated test scripts.
11.10(e)Use of secure, computer-generated, time-stamped audit trails to record operator actions.
Immutable record logs capturing creation, modification, or deletion with user ID, timestamps, and reason codes.
11.50Electronic signatures must show signer name, timestamp, and signature meaning (author, review, approval).
Step signatures capture precise timestamp and meaning metadata. Signatures are visually bound to final record PDFs.
11.200Electronic signatures employing dual-factor authentication (username and password credentials).
Enforces credentials re-validation modal on every quality sign-off, confirming identity before saving records.
Annex 11 (Ref 9)System access must be strictly controlled, ensuring only authorized personnel can execute specific steps.
Granular Role-Based Access Control (RBAC) with active directory single-sign-on (SSO) integration.
Technical Q&A

Frequently Asked Questions

How does QA Stack support 21 CFR Part 11 electronic signatures?+
QA Stack enforces dual-credential authentication (re-prompting for both username and password) at the exact moment of quality sign-off. The resulting StepSignature record captures the precise timestamp using RFC 3161 cryptographic servers, locks the historical dataset (`__locked: true`), and binds the signature meaning (e.g., Author, Reviewer, Approver) to the document audit trail.
What validation documentation is provided with the eQMS?+
We supply a complete GAMP 5 Validation Pack containing pre-executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols, User Requirements Specifications (URS), Functional Specifications (FS), and a Traceability Matrix. This documentation helps quality assurance teams slash internal validation cycles from months to days.
Can the eQMS handle multi-site global workflows?+
Yes. QA Stack utilizes secure site-based database partitioning, allowing local manufacturing sites to manage their own deviations, CAPAs, change controls, and equipment logs under independent site-level permissions, while corporate QA retains global data visibility and aggregated compliance reporting.
How are CAPA effectiveness checks managed?+
The system embeds an automated effectiveness check scheduler. Upon CAPA execution, the eQMS blocks deviation closure until a designated effectiveness check (configured by a time-interval, e.g., 90 days, or a batch-interval, e.g., 3 subsequent runs) has run. If the check fails, the parent deviation can automatically reopen or trigger escalation alarms.