Quality Processes and Events

Assure-IQ ensures streamlined processes, faster decisions and regulatory compliance. Combined with Caliber’s Document and Training Management systems, it ensures quality excellence.

A Quality Management System to Match Every Need

Assure-IQ is designed to streamline the complete quality assurance system. With 30+ modules to pick from, build a platform that suits you. Along with quality processes, document management and training management can be seamlessly integrated to manage the complete product lifecycle. The on-cloud and on-premise solutions are built on the latest technology to match the changing needs of the industry.

A flexible QMS that blends into your company’s systems can help you set your own benchmark for quality success. Deploy the system to match your needs and allow your team to easily adopt a digital upgrade!

Quality Management, Just As You Like It!

Every enterprise is unique in nature and structure. Your search for a quality management software that seamlessly fits in with your existing process ends with Assure-IQ.

Easy to configure and workflow-based Assure-IQ is loved by users for its flexibility. Configure multiple business rules with conditions and actions that allow you to replicate your process on the system.

Assure-IQ Highlights

Audit Management

Comply and manage complete internal and external audits with audit schedule, audit proposal, audit tracking, monitoring, audit trial, etc.

CAPA

Track, identify, and take corrective actions against any process errors from the root cause removing recurrence of future errors.
Trend Analysis

Deviation Control

Regulate and optimize any unplanned breaks preventing  unlikely variations in the product with full proof deviation control under compliance environment.
Area Mapping

OOS and OOT

Manage the multi-step procedure of OOS by automatically logging the data. Match the SOPs with audit tracking, document review, etc. all in a single system.

Reports & Analytics

Configurable dashboards, analytics, and actionable workflows for ready decision-making. With reporting engine schedule, generate and send various reports.

Pharmacovigilance

Implement and design your products in the complete interest of safety with regular QA responses for product queries, receiver details, case approval, MIS closure, etc.

Regulatory Compliance

Ensure an ongoing quality and GxP focus throughout the product lifecycle by streamlining your quality system. Stay assured of meeting the regulatory expectations and succeed during inspections, audits, and regulatory reporting with Assure-IQ.

Assure-IQ is designed to meet quality standards. It meets 21CFR Part 11, cGMP and GxP recommendations, latest FDA regulations, ISO 9001:2015 compliance and ALCOA +.  

Quality Assured, Success Assured with Assure-IQWhy Choose Assure-IQ?

Integrate with Other Systems Seamlessly

Assure-IQ integrates seamlessly with other systems without any interruptions to your quality system workflow. Get overall quality integration with your existing applications like ERP, directories, etc. It also integrates with other applications from Caliber product suite for a centralized quality management system.

Easily Configure Workflows

Quality systems with highly configurable workflows ease the complexity of quality processes that easily adapt to your business demands. Simplify the QA process with robust, flexible, and highly configurable workflows for report templates, E-form templates, etc. of Assure-IQ.

Assured Data Integrity

Assure-IQ assures complete data security with data encryption system (single sign on, E-password, etc.). Automate data integrity activities with features that increase the quality of data collection, data preservation, etc. The system is built to ensure data integrity and meets the principles of ALCOA Plus as per GxP.

Integrated with Docs-IQ

Define and streamline documents by integrating with Docs-IQ. Integration with Docs-IQ helps QA trigger document change requests through Change Control. Incorporate SOP management, document version, and revision, approval with complete regulatory compliance and unmatched collaboration and data integrity.

Integrate with Learn-IQ

Keep a check on deviations at any stage in the manufacturing process with CaliberBRM. Deviations occurring during manufacturing can get auto-triggered in the QMS system and a deviation process can be handled. CaliberBRM allows user to go ahead with the next stage of manufacturing only after the deviation has been addressed. With this, efficiency and quality, both can be controlled during manufacturing.

Integrate with CaliberBRM

Keep a check on deviations at any stage in the manufacturing process with CaliberBRM. Deviations occurring during manufacturing can get auto-triggered in the QMS system and a deviation process can be handled. CaliberBRM allows user to go ahead with the next stage of manufacturing only after the deviation has been addressed. With this, efficiency and quality, both can be controlled during manufacturing.

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