How can QT9 QMS enhance operating efficiency?

QT9 QMS enhances operating efficiency by reducing manual paperwork and improving workflow automation. It provides clear traceability of all processes and records.

How does QT9 QMS simplify 21 CFR Part 11 compliance?

QT9 QMS automates documentation, audits, and corrective actions to ensure adherence to 21 CFR Part 11 standards, helping reduce non-compliance risks.

How does QT9 QMS help reduce waste and costs?

QT9 QMS reduces errors, rework, and inefficiencies by enhancing quality control processes, leading to lower operational costs.

How does QT9 QMS increase customer satisfaction?

QT9 QMS enhances customer communication and helps resolve complaints quickly while improving the quality of all processes and products, resulting in higher customer satisfaction.

What is 21 CFR Part 11?

21 CFR Part 11 is an FDA regulation defining the criteria under which electronic records and signatures are considered equivalent to paper versions, ensuring the integrity and security of digital documentation.

Does 21 CFR Part 11 apply to my business?

It applies to organizations regulated by the FDA or supplying related products/services—such as pharma, biotech, medical devices, clinical labs, food & beverage, and cosmetics manufacturers.

How do I benefit from 21 CFR Part 11 compliance?

Compliance enables use of digital tools while ensuring record integrity and security. Benefits include reduced errors, faster approvals, automatic audit trails, better traceability, and minimized use of outdated documents.

What are FDA 21 CFR Part 11 requirements?

The regulation covers three subparts—General Provisions, Electronic Records, and Electronic Signatures—and includes requirements like system validation, readable records, audit trails, access controls, identity verification, and secure logins.

How does QT9 QMS help with FDA 21 CFR Part 11 compliance?

QT9 QMS automates document and record management with part-11 compliant e-signatures and secure cloud access. It includes 25+ modules designed to streamline regulatory compliance with high scalability and efficiency.

FDA 21 CFR Part 11 QMS Software

Q: How does QT9 QMS streamline audits & inspections?

QT9 QMS streamlines audits and inspections by automating scheduling, tracking, and reporting compliance data in one central place, making both internal and external audits more efficient.

Full Audit Trail

Any interaction with any record is date-, time- and name-stamped for a true preserved audit trail.

Electronic Signatures

Approve any type of record from virtually anywhere, anytime.

Fully Integrated System

Reduce your need for paper files, printers, copying machines, etc.

Closed-Loop System

No back doors, and logins are required for every section of QT9 QMS.

Enhance operating efficiency

Reduce manual paperwork and improve workflow automation. QT9 provides clear traceability of all processes and records.

Simplify 21 CFR Part 11 compliance

Ensure adherence to 21 CFR Part 11 standards by automating documentation, audits and corrective actions to help reduce non-compliance risks.

Streamline audits and inspections

Simplify internal and external audits by automating scheduling, tracking, and reporting compliance data in one central place.

Reduce waste and costs

Reduce errors, rework and inefficiencies by improving quality control that leads to lower operational costs.

Increase customer satisfaction

Enhance customer communication and resolve customer complaints quickly. Improve the quality of all processes and products to ensure happier customers.

Pre-validated QMS software

QT9 QMS is pre-validated for accelerated compliance.

FDA and ISO compliance out-of-the-box
Rapid cloud deployment for faster implementation
Audit-ready with timeline traceability
Electronic signature approvals and secure access controls
Continuous validation and updates

• ISO 13585
• ISO 9001
• ISO 14001
• ISO 17025
• AS9100
• MoCRA

• FDA 21 CFR Part 11
• FDA 21 CFR Part 210/211
• FDA 21 CFR Part 820
• EU GMP
• EU MDR
• GxP Compliance

QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
Reduces downtime waiting for your QMS to be approved for use.
Minimizes the risk of any failed audits due to flawed validation protocols.

FAQ: FDA 21 CFR Part 11

21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that outlines criteria for the use of electronic records and electronic signatures, as well as when they are “considered equivalent to paper records and handwritten signatures executed on paper.” The regulation’s intent is to ensure the integrity and security of electronic records and signatures.

Organizations that are regulated by the FDA or supply related products and/or services need to comply with 21 CFR Part 11. The most common of these industries include, pharmaceuticals, biotechnology, medical devices, clinical labs, food and beverage manufacturers, and cosmetic manufacturers.

For FDA-regulated companies, 21 CFR Part 11 compliance is mandatory, but it should not be considered a burden.

The goal of 21 CFR Part 11 is to allow businesses to use digital technology while ensuring the integrity and security of electronic records. Companies gain multiple efficiencies by adopting digital technologies and automating record-keeping and approval processes. Benefits include reducing margin of error, speeding document routing and approval, creating an automatic audit trail with easy trackability and traceability, and minimizing the risk of using outdated documentation.

FDA 21 CFR Part 11 has three subparts:

General Provisions
Electronic Records
Electronic Signatures

General requirements in Subpart B cover:

System validation
Readable records
Document storage and record retention
System access controls
Audit trails
Workflows
Authorized user checks
Device checks
Personnel qualifications
Personnel accountability
Document control

Requirements for Subpart C cover:

Identity verification
Security controls
Use of logins and passwords

For more detailed information visit https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11

With QT9 QMS, all of your document and record management is automated, including the ability to capture 21 CFR Part 11-compliant signatures. Our cloud-based platform makes electronic records and FDA-compliant signatures possible from any device, anywhere, at any time.

With more than 25 modules that come standard, QT9 QMS streamlines quality processes and regulatory compliance with powerful scalability and efficiency. We are a highly rated system, loved by customers. Reach out today for more information.