How does iQuality work for Life Science Industries?

iQuality is a configurable next-generation Quality Management Software for Life Science industries that enable organizations to manage, control, and gain deep insights into their quality processes with accelerated validation. It standardizes the workflow structure with electronic signatures, non-editable audit trails, and processes linking for end-to-end visibility meeting quality specification in adherence with FDA (Food and Drug Administration) 21 CFR (Code of Federal Regulations) Part 11 compliance ensuring customer satisfaction and compliance.

iQuality is a power-packed quality management suite that comes with essential modules and integrated document management software to deal with complex life science quality issues in a simplified innovative process.

Quality Management System

The iQuality QMS outlines how an organization will produce, document, control, and deliver a product or service possessing customer perceived value. QMS enables you to handle all your quality processes in an efficient way with the best features.

Features

Configurable Forms

Design iQuality forms in alignment with your organization's processes. The tabs, fields, sections can be modified according to your processes and best practice workflows.

E-Signature

iQuality's E-signature feature makes it easy for the users to handle their approval workflows and e-Sign wherever the process dictates. With this feature, you can assign records for people to do an E-sign, and properly certify them so they can avoid the hassle of paper documents review and minimize human errors by maintaining electronic records for your organization.

Attachments

Add all the supporting documentation for your CAPA, NC so that all the documentation for your issues is in one place.

Workflow Tracker

Workflow tracker provides high-level traceability to track your quality issues such as CAPA, NC, etc. Organizations can design the workflow tracker in alignment with their process flow.

Audit Logs

Compliant with FDA regulations, these audit logs are non-editable and track every micro change that occurs in your CAPA lifecycle.

Record Linking

Get a holistic view of your quality issues and link the other connected issues in the system. This feature enables you to have in-depth traceability of your CAPAs (corrective and preventative actions) and the related non-conformances, CAPAs, change requests, documents.

Print

The print option is available for you to print out any of the issues you have logged into iQuality.

Handle your CAPAs efficiently

Corrective Action and Preventive Action (CAPA) is one of the most crucial elements of a quality process. It outlines how an organization deals with potential non-conformities, product defects, customer complaints, and corrective and preventive measures for existing issues from reoccurrence.

With the custom configurable iQuality QMS (Quality Management System), the CAPA procedures can be defined as per the organization's needs and processes. iQuality's QMS allows you to identify and analyze the root cause encountered effectively with a custom-defined workflow tracker. Also, it helps to carry in-depth analysis, process linking with non-conformances and CAPA’s even those occurred and identified by different departments of the organization. The process can be configured according to the process followed by the organization to identify the root cause, implement an action plan, link records, attach documents proving the existence or findings, handle review and approvals, and capture and validate all minute details for inspections. Our QMS is an integrated platform designed by industry-leading quality experts.

Resolve non-conformances with 100% compliance

Seeking perfection in what we do is achievable. Yet, wanting an error-free world is a different story. But we can aspire to achieve near perfection. Likewise, to achieve high-quality product delivery or to minimize defective products, proper handling and documenting Non-Conformance scenarios is necessary. Along with it, monitoring, identifying underlying root causes, and implementing corrective actions will allow organizations to achieve near perfection results.

iQuality QMS is designed in a way to create and process Non-Conformances in a simplified manner. The system has role-based access controls which secure the confidentiality of the information added and is viewed only when authorized. NC (Non-Conformance) identified can assign it to another user, follow updates and collaborate investigation process until completion. The easy yet efficient review and approval assigning process allows the organization to permit users to assign multiple approvers for a record and enables them to choose the approvers from different implementation plants. QMS forms a centralized channel to communicate with NC creators, assignees, and approvals. Easy view of user-specific notifications and tasks helps issue traceability. All the information can be fed in a multi-tab model avoiding painful scrolling or moving to multiple pages. The fields are configurable as per organizations' needs to fill in as much information as needed.

Raise change requests and route them for approval in one click

Change Control plays a key role in life science industries. Every change that occurs should be processed or reported through the Change Control procedures and that should have the approvals signed by the organization’s authorized committee. It is prescribed to capture the change control processes carried out in the organization process. iQMS Change Control module will identify, capture, analyze, implement, and check the effectiveness of implemented processes ensuring meeting compliance with the regulatory standards as prescribed. The change request process can be custom configured to record, review, assign and authenticate approvals and implement new change procedures as per the standard process followed in the organization minimizing change cycle time and its impact.

Design your risk management plans and have them at your disposal in one click, anytime.

Every product manufactured and every process produced comes with associated risks. Zero risk- or risk-free processes or products are impossible to find and therefore risk management is given prime importance in life science industries to protect the quality of the product throughout its life cycle and protect customer's safety.

iQMS Risk Management module is a systematic process of assessment, control, implementation, and coordination across teams for review and approval. The process starts with identifying the risks associated with deviations of CAPA, product, or the processes followed to develop or manufacture or deliver products ensuring efficient science-based and compliance-related decisions.

Track your organization training plans and schedules easily

This is a module of iQMS designed especially for employee training requirements in the life science industry. From a compliance point of view to onboarding an employee, it is designed to act as a central control point for an organization's training program. With this, creating, distributing, and managing employee training is quite simple and leads to an efficient and happier workforce. This module allows you to create purpose-driven skill-oriented training for different job functions with the required documents and give employees a hassle-free experience of learning new techniques or processes.

Address and Resolve Complaints in the right way

iQMS Complaints Management module is designed to track and manage customer complaints and ensure the prevention of recurring issues, especially when identified the need for corrective action. This will allow you to identify, document and investigate and close complaints.

Plan your audits and implement them with 100% accuracy

This module will support several types of audit requirements to remain in FDA and ISO (International Standards Organization) regulations for the life science industries. Audits are painful and will cost brand reputation when unseen or unprepared. This system allows you to automate the audit process in connection with QMS ensuring the quality of process, products, and services. With this, you can efficiently keep track of the audit lifecycle, prepare checklists, define procedures, identify the cause, track the investigation methods, calculate risks, and analyze audits reducing time and effort.

DMS (Document Management System)

iQuality DMS is designed with central repository properties to efficiently manage and control document-related requirements in a life science industry. The system is integrated with QMS with a user-friendly interface that allows the user to create, document, review, and assign approval. It provides security to the confidential docs; centralized storage imposing controls with role-based access and streamlines search and easy retrievals whenever audit trails demand, making it easier for the organization to keep up their document management with the regulatory changes and maintain compliance through the document management cycle. Some of the key features include

• Check-in and check-out functions to log the edits and avoid overwrite actions of a user
• Allows users to collaborate and work on a document simultaneously without any hassle.
• Organization-specific workflow configurations to create document variant workflow for every document.
• E-Signatures for decision performed and Role-based access controls to take necessary actions on the document.
• All the edits and actions performed are captured and are displayed in non-editable audit logs for audit inspections.
• Integration with QMS so that you can link your CAPAs, NCs, Change requests to the relevant documents.

Reports and Analytics

iQuality QMS and DMS have module-specific and organization-level reports for measuring the effectiveness of the actions performed and analyze risk-based decisions. The custom dashboards can scale with your organization and will gather insights for decision-makers with context to business intelligence. The metrics detect the patterns which in turn help organizations to identify the CAPA’s root cause and NC sources. The reports and analytics offer recommendations on effective actions that companies can take to minimize risk.

We at iQuality have designed a cloud-based software that is easy to use, implement and drive change in the way quality management systems work. iQuality does not only serve compliance as a purpose, but it also serves the configurations of how an organization wants the quality process to be held in adherence to the industry standard regulations of 21 CFR Part 11. We aim to produce a solution that is easy, effective, and efficient in all aspects of regulations and quality.

Still, thinking?

You can take a call after talking to our solutions expert. The expert will understand your business pain points and provide you solutions on how you can leverage iQuality to address the pain points. Contact us for a product demo.