🖥️Overview

CIQA QMS: Revolutionizing Compliance and Productivity wit Cloud-Based Excellence

Welcome to the CIQA Quality Management System (QMS), an advanced solution designed to streamline regulatory compliance and boost productivity. Our secure, cloud-based Software as a Service (SaaS) platform ensures full compliance with 21 CFR Part 11, Part 211, and Part 820, making it suitable for a variety of industries.

Our QMS offers the following features to support your business:

• Centralized Document Management: Efficiently manage all regulatory compliance documents from a single, centralized location, enabling seamless data sharing and collaboration.

• Cloud Accessibility: Access the system from any location at any time, providing maximum flexibility and convenience.

• Streamlined cGMP Documentation: Simplify the identification, execution, documentation, and evaluation of quality management activities, fostering continuous improvement, risk mitigation, and enhanced customer satisfaction.

• Comprehensive Framework: Achieve quality objectives through standardization, compliance, efficiency, continuous improvement, and collaboration.

By choosing our QMS, you can focus on growth, confident that your quality management processes are expertly managed.

QMS Based on ALCOA & ALCOA+ Principles

Our QMS ensures data integrity through strict adherence to the ALCOA and ALCOA+ principles, which encompass:

ALCOA Principles:

1. Attributable: Clearly record the identity of the individual or system responsible for data collection or generation.

2. Legible: Ensure all data is readable, understandable, and unambiguous.

3. Contemporaneous: Document activities at the time they occur to maintain accurate timelines.

4. Original: Preserve the original records once registered in the system.

5. Accurate: Reflect true and precise records of actual events, ensuring no original information is lost or altered.

ALCOA+ Principles:

1. Complete: Capture all data, including initial data and metadata, with no omissions or deletions.

2. Consistent: Maintain a logical sequence of events with consistent and accurate timestamps, referencing a common time server.

3. Enduring: Record critical information directly onto authorized, durable media.

4. Available: Ensure all data is readily accessible for review, audit, or inspection throughout its lifecycle.

These principles ensure data integrity by upholding the highest standards of traceability, clarity, timeliness, authenticity, accuracy, and accessibility in data management. This rigorous approach guarantees the reliability and credibility of the data throughout its lifecycle, thereby supporting robust regulatory compliance and effective quality management.

By meticulously recording, storing, and controlling data within a secure cloud environment, our QMS upholds the highest standards of security and integrity.

Explore the CIQA QMS to enhance your regulatory compliance and quality management processes.