Updated on August 19, 2025

GxP - 21 CFR Part 11

This page is written for quality assurance, compliance, computer system validation, supplier qualification, and validation risk assessment teams.

The term GxP is a general abbreviation for good practice guidelines and regulations in the life sciences industry, including good clinical, laboratory, manufacturing, and other practices. There is no single regulatory entity or administration; each country has its own guidelines and regulators, although requirements are similar from country to country.

It explains how QTIS AI CORPORATION approaches FDA 21 CFR Part 11 (as enforced by the Food and Drug Administration (FDA) in the United States.) expectations for electronic records and electronic signatures across regulated computerized systems. It is intended to give reviewers a clear basis for confidence in our control environment and implementation maturity.

This page is written for quality assurance, compliance, computer system validation, supplier qualification, and validation risk assessment teams.

Organizational Position and Maturity

QTIS AI CORPORATION treats Part 11 as a disciplined quality and governance framework, not simply as a set of software features. Our systems are designed and operated in environments where electronic records must be attributable, complete, accurate, reviewable, and sustainable in a validated state throughout active use. We have significant experience leading regulated implementations across multiple organizations, including platforms that support clinical, quality, operational, and oversight workflows subject to inspection.

Control Framework Overview

Our Part 11 control framework combines technical design, procedural controls, and quality oversight so that regulated systems are both operationally reliable and defensible in a review.

Electronic Records

Electronic records are handled to preserve authenticity, integrity, confidentiality, availability, and appropriate retention. This includes:

Controlled creation, modification, storage, and retrieval of regulated data.
Protection against unauthorized overwrite, deletion, or obscuring of record content.
Procedures that govern record review, exception handling, retention, and archival.

Electronic Signatures

Where electronic signatures are part of the intended use, they are implemented as controlled process events linked to user identity and specific records. This includes:

Unique user identification and attributable capture of actions requiring signature.
Clear linkage between signatures, relevant records, and workflow steps.
Administrative control over roles, permissions, and signature authorizations.

Security and Access Governance

Access to regulated systems and records is governed through role‑based assignment and least‑privilege principles. This includes:

Segregation of duties between operational users, administrators, and approvers.
Controlled onboarding, change, periodic review, and deprovisioning of access.
Security governance appropriate for regulated environments and quality oversight.

Auditability and Traceability

Systems are configured to support review of who performed an action, what changed, when it occurred, and how evidence maps back to defined requirements. This includes:

Audit trail capability for relevant regulated events and administrative changes.
Traceability from requirements through specifications, testing, deviations, and approvals.
Support for investigation, deviation review, and inspection readiness.

Our Part 11 control framework combines technical design, procedural controls, and quality oversight so that regulated systems are both operationally reliable and defensible in a review.

Electronic Records

Electronic records are handled to preserve authenticity, integrity, confidentiality, availability, and appropriate retention. This includes:

Controlled creation, modification, storage, and retrieval of regulated data.
Protection against unauthorized overwrite, deletion, or obscuring of record content.
Procedures that govern record review, exception handling, retention, and archival.

Electronic Signatures

Where electronic signatures are part of the intended use, they are implemented as controlled process events linked to user identity and specific records. This includes:

Unique user identification and attributable capture of actions requiring signature.
Clear linkage between signatures, relevant records, and workflow steps.
Administrative control over roles, permissions, and signature authorizations.

Security and Access Governance

Access to regulated systems and records is governed through role‑based assignment and least‑privilege principles. This includes:

Segregation of duties between operational users, administrators, and approvers.
Controlled onboarding, change, periodic review, and deprovisioning of access.
Security governance appropriate for regulated environments and quality oversight.

Auditability and Traceability

Systems are configured to support review of who performed an action, what changed, when it occurred, and how evidence maps back to defined requirements. This includes:

Audit trail capability for relevant regulated events and administrative changes.
Traceability from requirements through specifications, testing, deviations, and approvals.
Support for investigation, deviation review, and inspection readiness.

Validation Discipline and Lifecycle

QTIS AI CORPORATION applies a risk‑based computerized system lifecycle that covers qualification, validation, deployment, operation, and retirement. The objective is to show that systems perform as intended, support regulated processes, and remain in a state of control over time.

Validation Package Readiness

Validation deliverables are structured so that reviewers can follow intended use, control design, verification coverage, deviation handling, and approval history without ambiguity. Typical elements include:

User and system requirements and functional specifications aligned to Part 11 needs.
Configuration and design descriptions that explain how controls work in practice.
Traceability matrices and verification evidence showing coverage of critical risks.
Deviation and issue records, summary reports, and documented approvals.

Change Control and State of Control

System updates are managed through formal impact assessment, approval, regression consideration, and controlled release. This is designed to preserve the validated state and inspection readiness. Key practices include:

Assessing the effect of changes on regulated functionality and records.
Planning and executing verification activities appropriate to the risk of each change.
Updating documentation and retaining evidence of decisions and outcomes.
Maintaining a clear view of system status for quality and compliance stakeholders.

Operational Governance and Shared Responsibility

Part 11 readiness depends on sustained operational governance, not only on system configuration. QTIS AI CORPORATION supports governance practices that include procedure alignment, incident handling, periodic review, training accountability, backup and recovery control, and data retention oversight. In a shared‑responsibility model,

QTIS AI CORPORATION provides a controlled technical foundation and implementation discipline, while regulated customers retain ownership of intended use, business process definitions, approval workflows, procedural enforcement, and ultimate compliance decisions within their own quality systems.

Experience with Regulated Implementations

QTIS AI CORPORATION has led and supported implementations of regulated platforms across multiple organizations. These implementations support clinical operations, quality management, oversight reporting, and other workflows in which electronic records and signatures are subject to sponsor and regulatory scrutiny.

This experience informs a practical compliance model that reflects real validation demands, cross‑functional review, and the need to maintain control under active business use rather than in static environments.

Changes to this policy

We may update this policy to reflect changes in our services or the law. We will notify you of significant changes.

Contact us

If you have questions or concerns, please email us at compliance@qtis.ai

If you have questions or concerns, please email us at support@q