QA Central

Quality Management System for Pharmaceuticals & Life Sciences

Reduce your paperwork and Cost-of-Compliance (COC) with the best Quality Management tool, designed for an easy adoption, targeted specifically for pharmaceutical, biotech, and regulated industries.

Explore QMS Features

Critical Challenges in Manufacturing and Operations

Running a smooth and cost-effective operation is essential for business success. However, many industries face persistent challenges that increase costs, reduce efficiency, and impact overall productivity.

High Costs and Vendor Lock-in – International vendors often push expensive solutions that require businesses to invest in additional products or services, leading to increased operational costs and reduced flexibility.
Lack of Real-time Traceability – Poor tracking systems result in delays, miscommunication, and inefficiencies in inventory management, production workflows, and order fulfillment. Without real-time insights, businesses struggle to monitor progress effectively.
Regulatory Compliance Complexities – Strict industry regulations demand meticulous documentation and adherence, making compliance a resource-intensive and time-consuming process. Failure to comply can result in legal penalties and reputational damage.
Limited Customer Support – Many solutions offer inadequate customer support, leaving businesses without timely assistance when technical issues or urgent operational challenges arise.
Manual Processes Hindering Productivity – Dependence on paperwork slows down workflows, increases operational costs, and limits productivity, making it harder for businesses to scale efficiently.
Human Errors Leading to Financial Losses – Manual data entry and disconnected systems lead to frequent errors, causing miscommunication, compliance failures, and costly rework.

Vendor Qualification

Vendor Qualification ensures a streamlined approval process with customizable workflows, multi-level approvals, audit management, and a Vendor Portal for secure communication and document handling.

Customizable Workflow.
Configurable Multi-Level Approval Process.
Conditionally approve a qualification request, with remarks for each product.
Manage a list of qualified vendors for quick activation and deactivation.
Manage audit schedules and perform site audit.
Vendors get access to Vendor Portal, for all communication, secure document uploads and accepting/proposing audit dates.

Change Control

Change Control ensures a structured and compliant process for managing changes with customizable workflows, multi-level approvals cross-department collaboration, and a complete audit trail. It enables secure document handling and real-time tracking of action items to meet regulatory standards.

Customizable Workflow.
Configurable Multi-Level Approval Process with Multiple Reviewers.
Collaborate with Stakeholders across departments on Action Items, track progress of each Action Item.
Complete Audit Trail, meets regulatory standards.
Upload supporting documents securely.

Complaints

The Complaints Management system streamlines issue resolution with customizable workflows, multi-level approvals, and real-time tracking. It enables direct customer acknowledgments, audit management, and vendor collaboration through a secure portal for communication and document handling.

Customizable Workflow.
Configurable Multi-Level Approval Process with Multiple Reviewers.
Send acknowledgement emails to customers directly, within the application.
Track Complaint Redressal progress.
Manage audit schedules and perform site audit.
Vendors get access to Vendor Portal, for all communication, secure document uploads and accepting/proposing audit dates.

Non-Conformance

Non-Conformance Management ensures effective handling of incidents, deviations, and compliance issues with customizable workflows and multi-level approvals. It facilitates cross-department collaboration, vendor qualification management, audit scheduling, and secure communication through a Vendor Portal.

Incidents | Planned and Unplanned Deviations.
Customizable Workflow.
Configurable Multi-Level Approval Process with Multiple Reviewers.
Collaborate with Stakeholders across departments on Action Items.
Manage a list of qualified vendors for quick activation and deactivation.
Manage audit schedules and perform site audit.
Vendors get access to Vendor Portal, for all communication, secure document uploads and accepting/proposing audit dates.

Investigations

Investigations Management streamlines root cause analysis with customizable workflows, multi-level approvals, and real-time collaboration. It includes configurable alerts, supports methodologies like Fishbone and Five Whys, and ensures structured case management for thorough investigations.

Customizable Workflow, to meet everyone’s requirement.
Configurable Multi-Level Approval Process with Multiple Reviewers, ex. Dept Head, QA Head.
Never miss a deadline with our Configurable Notifications and Alerts.
Collaborate with all investigators, working simultaneously.
Supports Fish-bone, Five Whys and more.
Case Management.

Audits

Our Audit Management System is designed to streamline your compliance processes while enhancing productivity and reducing costs. With Fiscal Ox's Audit Management, you can simplify compliance, reduce manual effort, and ensure your organization meets regulatory standards efficiently.

Mitigate Risk by ensuring all Audit Steps / Checklists are completed.
Increase productivity with configurable Workflows, Cross-Department Collaborations and Email/Whatsapp Notifications.
Request Vendor Audits directly via the Application, Vendor acceptance via email link or Vendor Portal.
Collaborate with Stakeholders across departments on Action Items.
Fully integrated with Quality Management System.
Reduce Cost of Quality (CoQ) by electronic Audit Reports, Authorizations and Distribution Processes.