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Quality Management

Quality control and management are critical for life sciences companies to ensure product safety, comply with stringent regulations, and maintain market trust.  

However, companies often struggle with complex, disjointed systems comprising multiple, expensive add-on solutions, which make quality control and management costly, cumbersome, and error-prone.  

STAEDEAN provides a centralized quality management software embedded in Microsoft Dynamics 365 Finance and Supply Chain Management (F&SCM) ERP that streamlines processes, ensures coordination, and enhances data transparency.  

The end-to-end system reduces manual errors, ensures data integrity, and strengthens security with a single source of truth, providing greater transparency, accuracy, and compliance. 

Scroll down to check how our ERP software can benefit you.  

 

Key Challenges

High risk of non-compliance
Manufacturing safe drugs involves strict adherence to regulations like CFR and GMP. Even minor errors in quality can lead to costly recalls and hefty fines. With our Pharma quality management software, stay up to date with all regulatory norms and stay compliant.
Complex and costly quality management
Most life sciences companies invest heavily in various add-on solutions like LIMS and ERP to manage and control quality, making the process complex and costly. Simplify the process and improve efficiency with one centralized platform.
Difficulties managing vast data
Ensuring transparency of the vast amount of data from clinical trials, research, and manufacturing is cumbersome. Maintain data transparency, integrity, and accuracy with an all-inclusive life sciences quality management software.

Sample and batch management

From selecting samples to tracing their destination, simplify the entire process using a dedicated workflow. Improve compliance with secure batch review and approval processes and manage every aspect of your batches with a user-friendly, comprehensive workflow.

Project management and work scheduling for stability studies

Manage revenue and cost and generate financial reports with accounting tools for lab services. Track output and simplify lab skill management with automated scheduling and work tracking.

Quality reporting and supplier qualification

Get reports directly from the ERP. Review and approve quality results that are automatically compared to test specifications. Track, monitor, and record supplier qualifications.
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Benefits

All-in-one solution

Get the benefits of a laboratory information management system that is part of a comprehensive and single, integrated system. The solution offers access to vast amounts of data in real time that can help with planning, forecasting, and decision making.

Reduce cost

Control costs by eliminating the need for expensive add-ons. Get all the solutions you need in one comprehensive system.

Improve transparency

Get visibility into all aspects of laboratory controls. Meet all your quality control needs, right from the initial clinical stages to production and distribution.

Stay compliant

From Life Sciences GMP guidelines to country-specific regulations, ensure compliance and adherence to industry-accepted standards around the world.

Improve accuracy

Manual, paper-based processes are effort intensive and prone to errors. Reduce paper-based processes and improve data accuracy and integrity across your operations by automating data processes. 

Improve process efficiency

Automate manual processes to reduce effort and errors. Get insights into data and view accurate information in real time.

Features

Efficient Laboratory Operations

Efficient Laboratory Operations

Enhance laboratory efficiency, simplify workflows, ensure compliance through secure reviews, and get comprehensive control over every aspect of batch management.

Quality Control Operations

Quality Control Operations

Seamlessly enter, review, and approve test results against specifications using automated quality control.

Enhanced Product Quality

Enhanced Product Quality

Maintain high product quality throughout the project lifecycle with integrated accounting tools.

Supplier Evaluation

Supplier Evaluation

Actively track, monitor, and record supplier qualifications for greater transparency and reliability.

Secure and compliant data management

Secure and compliant data management

Meet the requirements of 21 CFR Part 11, EU Annex 11, and more with our Pharma quality management software.

Data reporting

Data reporting

Create detailed reports from tests and quality checks to support data analysis for annual product reviews.

Frequently asked questions

Can't find what you're looking for?

Can your solution guide quality tests and record results? 

Yes, quality tasks can be traced in the system, including lab analysis, inspections, and documents verifications. Tests/controls to be executed can be defined based on the material and its purpose (e.g., commercial use or R&D). Results can be recorded in the system and used to run a final quality assessment. 

Does your solution support reduced/skip test calculations? 

Yes, it can define when reduced testing is allowed based on the material and vendor qualification status, as well as the frequency of mandatory full testing (defined by days or by the number of batches received). When reduced testing is applicable, non-mandatory tests can be skipped. 

How does your solution help manage samples? 

You can manage sample inventory in the system (receipt, storage, shipping, destruction). Define rules to automatically calculate sample container count, quantity, unit, and types required. The solution integrates with the Weighing and Dispensing module, allowing sample preparation by connecting the ERP with scales. 

Can periodic quality controls be scheduled and planned?  

The solution allows you to plan recurrent quality controls for environmental monitoring. It also helps you define the recurrence period and controls to be executed. You can plan quality controls to support stability studies testing as well.

How does the solution manage lot/batch status and usability? 

You can assign/change batch quality status. Based on the status, the batch will be available or blocked for consumption, transfer, shipping, etc. Controls to manage batch status include: 

- Changing batch status, which is allowed only for users with proper permission 

- Blocking the release of a batch with unreleased components 

- Blocking the release of a batch without a manufacturing date 

Resources

Scroll to

    Life Sciences Quality Management Factsheet

    Achieve quality control, cut costs, and minimize paperwork with a single integrated module, designed to meet life sciences regulatory guidelines.
    02-AXP365-Pharma-Advanced-Quality-Management-v2

    Modernizing ERP systems - A guide for Life Sciences

    Discover the importance of moving to the cloud. Learn the key migration steps and why choosing the right ERP partner is crucial for seamless cloud implementation.
    The-Business-Case-for-Modernizing-your-ERP-System-ebook

    How your company can boost its market value - An eBook

    A Dynamics 365 upgrade can save you USD 10.6 million! Know more about it and other benefits of technological advancements in life sciences industry.
    08-AXP365-Advanced-Finance-Management-v1

    Digital Quality Control Systems/Laboratory Information Management Systems (LIMS) and the Evolution of CDMOs

    Jan 1, 1970
    Laboratory Information Management Systems (LIMS) can help you outpace your competition. Read the blog to understand its benefits for your organization.

    How STAEDEAN Life Sciences solution automates stability studies

    Jan 1, 1970
    Discover why stability studies are vital for pharmaceutical companies and how STAEDEAN Life Sciences solution helps streamline their management.

    How STAEDEAN Life Sciences Solution Helps Comply with FDA ICH Q6A

    Jan 1, 1970
    Ensure compliance with FDA ICH Q6A requirements and efficiently manage specifications with the right ERP features. Learn how STAEDEAN’s Life Sciences solution can help.
    How STAEDEAN Life Sciences Solution Helps Comply with FDA ICH Q6A
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