Qualityze CAPA Management Solution is designed to help organizations take a holistic approach to eliminate systemic quality issues and prevent their recurrence. It builds a closed-loop CAPA workflow to determine, analyze, and eliminate the actual root cause, enabling organizations to take a proactive approach to risk management. It is a cloud-based, configurable solution that enables your quality teams to align different investigation tools, including 5 Whys, Fishbone, and many more, with CAPA processes for effective and efficient resolution.
Qualityze CAPA Management comes with advanced reporting tools and an audit trail that increases traceability through CAPA trends and encourages informed decision-making. Furthermore, you can reduce the cost of product rework and meet compliance with applicable regulatory standards. It seamlessly integrates with existing business applications to give you more control and confidence in managing CAPA records. Let Qualityze CAPA Management Solution manage your CAPA-related processes efficiently than ever.
Get detailed information on the CAPA module in the following presentation.
If you have any more questions, please get in touch with us at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.
Capa quality system – more than just corrective actionQuality Management
http://qualitymanagementsystem.com/what-is-iso/capa-quality-system-more-than-just-corrective-action/
A CAPA Quality System (CAPA is an acronym for ‘Corrective and Preventive Action’, or ‘Corrective Action, Preventive Action’) is absolutely essential in some format for a complete quality management program. In fact, in at least one quality management system, Good Manufacturing Practices (GMP), it is a requirement and a fundamental tenet of the program. GMP is the quality management system that must be used by pharmaceutical and medical equipment manufacturers to comply with FDA guidelines.
Overview of the apporach to non-compliances and related matters. Appropriate training for analysts on how to perform the tests and steps to take when obtaining OOS results should be implemented . The use of root cause analysis tools when finding an OOS should also be available for review.
Capa quality system – more than just corrective actionQuality Management
http://qualitymanagementsystem.com/what-is-iso/capa-quality-system-more-than-just-corrective-action/
A CAPA Quality System (CAPA is an acronym for ‘Corrective and Preventive Action’, or ‘Corrective Action, Preventive Action’) is absolutely essential in some format for a complete quality management program. In fact, in at least one quality management system, Good Manufacturing Practices (GMP), it is a requirement and a fundamental tenet of the program. GMP is the quality management system that must be used by pharmaceutical and medical equipment manufacturers to comply with FDA guidelines.
Overview of the apporach to non-compliances and related matters. Appropriate training for analysts on how to perform the tests and steps to take when obtaining OOS results should be implemented . The use of root cause analysis tools when finding an OOS should also be available for review.
Corrective Actions and Risk management for ISO 9001:2015sundaybizsys
The Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective and preventive actions, internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects and risk management. Compile and analyze Customer Survey results. Document QMS review meetings and results. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
This ppt contains ISPE guidelines for Pharmaceutical Engineering, activities in Good Engineering Practices, Risk Management in GEP, Cost Management in GEP, ISPE guide for GEP, SOP in GEP, project engineering,Change Management IN GEP.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
CIMCON Software is an ideal partner to accelerate your Digital Transformation journey. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe.
Corrective Actions and Risk management for ISO 9001:2015sundaybizsys
The Quality Database is a simple, inexpensive ISO 9001 compliant program that allows small businesses to efficiency manage the Quality System. The database tracks corrective and preventive actions, internal audit tracking, safety improvement, supplier corrective actions, continual improvement projects and risk management. Compile and analyze Customer Survey results. Document QMS review meetings and results. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.
Risk assessment for computer system validationBangaluru
A risk assessment is a process to identify potential hazards and analyze what could happen if a hazard occurs.
Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.
Self-inspection should be carried out in order to verify compliance by the enterprise with the requirements of these Rules and suggest the necessary corrective actions.
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
Introduction to Change Control.
Definition of Change Control.
Function of Change Control.
Area of Change.
Written Procedures and Documentation.
This ppt contains ISPE guidelines for Pharmaceutical Engineering, activities in Good Engineering Practices, Risk Management in GEP, Cost Management in GEP, ISPE guide for GEP, SOP in GEP, project engineering,Change Management IN GEP.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
CIMCON Software is an ideal partner to accelerate your Digital Transformation journey. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe.
Qualityze is an enterprise quality management system (EQMS) built on the salesforce platform It helps manufacturers and other industry suppliers meet their quality and compliance goals by connecting all relevant processes across the company.
Qualityze EQMS Suite consist of next generation quality management software that can help all types of industries. All the process are developed on salesforce platform and ensures to meet quality norms.
Best Enterprise Quality Management SoftwareQualityze Inc
Qualityze EQMS Suite is a comprehensive solution that enables organizations to proactively manage their quality, safety, and compliance issues while fostering a culture of continuous improvement. It is a set of ten powerful modules that helps to build a closed-loop quality management system. Each module comes with unique functionalities and can seamlessly integrate with the existing business applications to provide more control and confidence in managing data. It also enables you to make data-driven decisions to reduce overhead expenses.
Qualityze is an easy-to-customize, intuitive, and powerful quality management solution that can scale with your business’ ever-growing and changing needs. It is driven on a cloud platform, so you can leverage more flexibility and accessibility to manage business processes globally. It comes with pre-defined templates, audit trails, configurable workflows, electronic signatures, and much more. Get detailed information on each module in the following presentation.
If you have any more questions, please get in touch with us at 1-877-207-8616 or write to us at info@qualityze.com, and we will be right there for you.
Quality Management software helps organizations maintain uniformity and consistency in their products and services. It focuses on end-to-end processes, right from the quality of products and services to the activities and means to achieving it and consistently managing it. One such tool is - BM QualityMaster. It allows businesses to improve quality, achieve compliance, decrease risk, and reduce complaints by streamlining their quality management. Check out the PPT to know further-
CIMCON Software is an ideal partner to accelerate your Digital Transformation journey. With offices in the US, UK and Asia-Pacific, 500 customers in 30 countries, 24/7 support, and partnerships with multiple Cloud and technology vendors as well as Value-Added Resellers across the globe.
La Importancia del Análisis de la InformaciónNexolution
Estudios demuestran que las empresas que aplican la analítica obtienen unos resultados mejores que los de sus iguales. Y aquellas organizaciones con un alto Cociente Analítico es decir, con una filosofía general basada en analítica, tienen un rendimiento medio tres veces superior.
La analítica de negocio permite que su organización identifique las tendencias y los patrones sutiles de modo que pueda anticiparse y controlar los acontecimientos para mejorar los resultados.
Lo invitamos a ver nuestro webcast "La importancia del análisis de la información para la toma de decisiones", donde le mostraremos:
- En qué están invirtiendo las empresas actualmente para optimizar su desempeño
- Descubra cómo lograr un análisis profundo de la información para la mejor toma de decisiones a través de una estrategia de Analítica de Negocios
- Analice el grado analítico de su empresa para la toma de decisiones
Presentador: Sergio Velazquez
Información de las soluciones: informacion@nexolution.com
Happy & Healthy - Automated Process and System Health Checks for your Atlassi...Cprime
As you plan to scale your agile development initiatives by implementing new projects, adding new practitioners and end users and delivering business value across the enterprise, you need to ensure the health, governance, and overall operational efficiency of your underlying enterprise software solutions.
In this webinar we’ll introduce cPrime’s a Software & Services Health Report. This service analyzes your Atlassian environment highlighting critical process & software issues hiding in your instance.
In this session you will learn how:
Best practices gleaned from our team of agile thought leaders and technical solutions experts were distilled into an automated audit report
The report can be customized by adding your own specific health measurement and metrics
The report can help you in the laying the solid foundations you need in order to scale and implement governance and best practices.
The frantic pace of innovation, growth and scale can ultimately win over governance, guardrails, best practices and sound management of your underlying software platform.
The solution – You need Testing as a Service (TaaS) – also known as an On-Demand testing service – to help you scale with agility and overcome the typical traditional testing bottlenecks.
EzyPro has expanded its foot print with the integration of computerized maintenance management system. With this from a compliance and quality management system the scope has expanded to a productivity, problem-solving and efficiency enhancing software as a service
Compliance and Competitive Advantage - The Intelligent QMSEMMAIntl
The ongoing changes in the international regulatory landscape will have a direct impact on quality management systems’ (QMS) design and implementation. Thus, this is an appropriate time to reveal a new approach to QMS thinking and analysis that will undoubtedly pave the way to the future of QMS architecture. The purpose of this webinar is to introduce some new and innovative concepts that are aimed at taking our current thinking into the future. And yes, this includes incorporating Artificial Intelligence into the design and architecture of a QMS.
Optimizing Your SAP ECC Landscape and S/4HANA Readinesspanayaofficial
Does the new normal mean you’ll be keeping your SAP landscape on ECC for the short to mid-term? Are you confident that changes being made in ECC6 are getting you closer to a future S/4HANA conversion, or are they taking you in the opposite direction?
Check out the webinar slides to learn more about how XfilesPro transforms Salesforce document management by leveraging its world-class applications. For more details, please connect with sales@xfilespro.com
If you want to watch the on-demand webinar, please click here: https://www.xfilespro.com/webinars/salesforce-document-management-2-0-smarter-faster-better/
Paketo Buildpacks : la meilleure façon de construire des images OCI? DevopsDa...Anthony Dahanne
Les Buildpacks existent depuis plus de 10 ans ! D’abord, ils étaient utilisés pour détecter et construire une application avant de la déployer sur certains PaaS. Ensuite, nous avons pu créer des images Docker (OCI) avec leur dernière génération, les Cloud Native Buildpacks (CNCF en incubation). Sont-ils une bonne alternative au Dockerfile ? Que sont les buildpacks Paketo ? Quelles communautés les soutiennent et comment ?
Venez le découvrir lors de cette session ignite
We describe the deployment and use of Globus Compute for remote computation. This content is aimed at researchers who wish to compute on remote resources using a unified programming interface, as well as system administrators who will deploy and operate Globus Compute services on their research computing infrastructure.
top nidhi software solution freedownloadvrstrong314
This presentation emphasizes the importance of data security and legal compliance for Nidhi companies in India. It highlights how online Nidhi software solutions, like Vector Nidhi Software, offer advanced features tailored to these needs. Key aspects include encryption, access controls, and audit trails to ensure data security. The software complies with regulatory guidelines from the MCA and RBI and adheres to Nidhi Rules, 2014. With customizable, user-friendly interfaces and real-time features, these Nidhi software solutions enhance efficiency, support growth, and provide exceptional member services. The presentation concludes with contact information for further inquiries.
Gamify Your Mind; The Secret Sauce to Delivering Success, Continuously Improv...Shahin Sheidaei
Games are powerful teaching tools, fostering hands-on engagement and fun. But they require careful consideration to succeed. Join me to explore factors in running and selecting games, ensuring they serve as effective teaching tools. Learn to maintain focus on learning objectives while playing, and how to measure the ROI of gaming in education. Discover strategies for pitching gaming to leadership. This session offers insights, tips, and examples for coaches, team leads, and enterprise leaders seeking to teach from simple to complex concepts.
Navigating the Metaverse: A Journey into Virtual Evolution"Donna Lenk
Join us for an exploration of the Metaverse's evolution, where innovation meets imagination. Discover new dimensions of virtual events, engage with thought-provoking discussions, and witness the transformative power of digital realms."
Software Engineering, Software Consulting, Tech Lead.
Spring Boot, Spring Cloud, Spring Core, Spring JDBC, Spring Security,
Spring Transaction, Spring MVC,
Log4j, REST/SOAP WEB-SERVICES.
Globus Connect Server Deep Dive - GlobusWorld 2024Globus
We explore the Globus Connect Server (GCS) architecture and experiment with advanced configuration options and use cases. This content is targeted at system administrators who are familiar with GCS and currently operate—or are planning to operate—broader deployments at their institution.
Innovating Inference - Remote Triggering of Large Language Models on HPC Clus...Globus
Large Language Models (LLMs) are currently the center of attention in the tech world, particularly for their potential to advance research. In this presentation, we'll explore a straightforward and effective method for quickly initiating inference runs on supercomputers using the vLLM tool with Globus Compute, specifically on the Polaris system at ALCF. We'll begin by briefly discussing the popularity and applications of LLMs in various fields. Following this, we will introduce the vLLM tool, and explain how it integrates with Globus Compute to efficiently manage LLM operations on Polaris. Attendees will learn the practical aspects of setting up and remotely triggering LLMs from local machines, focusing on ease of use and efficiency. This talk is ideal for researchers and practitioners looking to leverage the power of LLMs in their work, offering a clear guide to harnessing supercomputing resources for quick and effective LLM inference.
Enhancing Research Orchestration Capabilities at ORNL.pdfGlobus
Cross-facility research orchestration comes with ever-changing constraints regarding the availability and suitability of various compute and data resources. In short, a flexible data and processing fabric is needed to enable the dynamic redirection of data and compute tasks throughout the lifecycle of an experiment. In this talk, we illustrate how we easily leveraged Globus services to instrument the ACE research testbed at the Oak Ridge Leadership Computing Facility with flexible data and task orchestration capabilities.
Top Features to Include in Your Winzo Clone App for Business Growth (4).pptxrickgrimesss22
Discover the essential features to incorporate in your Winzo clone app to boost business growth, enhance user engagement, and drive revenue. Learn how to create a compelling gaming experience that stands out in the competitive market.
Enhancing Project Management Efficiency_ Leveraging AI Tools like ChatGPT.pdfJay Das
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Providing Globus Services to Users of JASMIN for Environmental Data AnalysisGlobus
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Cyaniclab : Software Development Agency Portfolio.pdfCyanic lab
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May Marketo Masterclass, London MUG May 22 2024.pdfAdele Miller
Can't make Adobe Summit in Vegas? No sweat because the EMEA Marketo Engage Champions are coming to London to share their Summit sessions, insights and more!
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In 2015, I used to write extensions for Joomla, WordPress, phpBB3, etc and I ...Juraj Vysvader
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TROUBLESHOOTING 9 TYPES OF OUTOFMEMORYERRORTier1 app
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Developing Distributed High-performance Computing Capabilities of an Open Sci...Globus
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2. Index:
1. Qualityze CAPA Management – Introduction
2. QCa – What’s the Need?
3. QCa – Quality Management Challenges It Helps Overcome
4. QCa – Workflow
5. QCa – Exclusive Features
6. QCa – Salesforce Platform Benefits
7. QCa – Industries It is Suitable For
8. QCa – Pros and Cons
9. FAQ’s
10. Contact Us
11. Thank-You
3. Introduction:
Qualityze CAPA Management Software enables quality teams to identify, manage, and resolve
systemic issues through a standardized CAPA process, so they don't reoccur. It uses advanced
reporting and analytics to track the problems that enable organizations to build an effective
action plan and make data-driven decisions. It simplifies root cause investigation and analysis to
detect quality problems quickly, ensuring faster CAPA cycles.
Qualityze CAPA Management Process seamlessly integrates with existing quality management
solution to provide better quality control and improve decision-making.
With Qualityze CAPA Management, you can:
• Record CAPA-Related Information to Assess Risks
• Minimize the CAPA Cycle Time
• Ensure CAPA Effectiveness
• Integrate the Nonconformance and CAPA Processes
• Leverage Seamless Integration with Existing Business Systems
• Drive Continuous Improvement
• Manage Controlled CAPA Records and Data
4. What's the Need?
A CAPA process is considered as the core of a quality system. It has a vital contribution in
achieving product quality, safety, and regulatory compliance. It eventually increases
customer satisfaction and improves the brand reputation. When CAPA is not appropriately
implemented, it may impact your workforce productivity by keeping them busy in
repetitive product failures and recalls. It implies the need for a truly effective and efficient
CAPA Management System.
And Qualityze CAPA Management Solution is the one you can rely on. It comes with
configurable forms and workflows that you can customize based on the industry's best
practices, ensuring consistency, efficiency, and compliance. It can be easily integrated with
the existing quality management systems to take a holistic approach to resolve quality
issues. The advanced reporting provides meaningful insights in real-time so your quality
manager can work more proactively towards the quality improvements.
5. Quality Management Challenges It
Helps Overcome:
Using Qualityze CAPA Management System software, you can overcome numerous quality
management challenges, including:
• Longer Process Cycles.
• Search and Retrieval of Documents.
• Traceability of Quality Issues.
• Compliance Issues.
• Collaboration and Communication.
• Increased Costs of Paper-Based CAPA Systems.
• Reliability of the Manual Root Cause Investigation.
6. Workflow:
Qualityze CAPA Management System Software is a configurable, cloud-based solution that
enables organizations to address quality issues effectively that they don't reoccur. From
reporting a CAPA issue to its root cause investigation, developing and implementing an
action plan to verify its effectiveness, you can perform all the workflow steps without
excessive training.
With Qualityze CAPA Management Software, you can standardize the process workflows
to:
• Initiate a CAPA with Critical Information
• Plan the Most Appropriate Resolution
• Investigate to Determine Actual Root Cause
• Perform Risk Assessment
• Define and Implement the Action Plan
• Perform the Verification and Effectiveness Steps
• Resolve the Quality Issues
7. Exclusive Features:
Qualityze CAPA Management comes with a set of unique features such as:
1. Centralized CAPA Database to store all your CAPA records in one place.
2. Dashboards & Reports to facilitate CAPA tracking and analysis.
3. Best-Practices Forms and Workflows for consistent and compliant data collection.
4. Electronic Signatures to maintain compliance with FDA 21 CFR Part 11.
5. Risk Matrix to simplify evaluation of risks associated with CAPA.
6. Follow-Up feature to receive alerts on activities done on a particular CAPA record.
7. Seamless Integration to make a holistic approach for eliminating quality issues.
8. Salesforce Platform Benefits:
Built on the most powerful and secure cloud platform, i.e., Salesforce.com, Qualityze
leverages enterprises:
• Flexibility, Scalability, and Security
• Improved Accessibility and Traceability
• Better Collaboration and Communication
• Low Implementation and Maintenance Costs
• Seamless Integration with Third Party Applications
• User-Friendly Interface
• Configurable Workflows and Fields
9. Industries It is Suitable For:
Qualityze CAPA Management is suitable for different industries, including:
1. Lifesciences
2. Medical Devices
3. Healthcare
4. Aerospace and Defense
5. Automotive (including Electric Vehicles)
6. Food and Beverages
7. Pharmaceuticals
8. Nutraceuticals
9. Manufacturing
10. Logistics
11. Consumer Goods
12. Cannabis
13. Biologics
14. Biotechnology
15. Construction
16. Oil and Gas
17. Hospitality
18. Chemicals and Agrochemicals
10. Pros and Cons:
Pros of Qualityze CAPA Management Software
• It comes with a free demonstration.
• It doesn't require specialized training.
• It has a user-friendly and intuitive interface.
• It helps comply with industry best-practices.
Cons of Qualityze CAPA Management Software
• No information about the free trial period or pricing online.
• Webinars not available.
11. FAQ’s:
Q. What makes Qualityze CAPA Management different?
A. Well, it is delivered on a compliant-ready platform, i.e., Salesforce.com, that ensures
more flexibility, security, and scalability to manage CAPA records in a compliant manner.
Q. Can we make changes to CAPA forms on our own?
A. Yes, with admin rights only. You can customize the workflow and forms through
Qualityze Central.
Q. What quality issues can we manage through Qualityze CAPA Management?
A. Every issue, including improper design; inadequate product specification; failure of
purchased materials; preliminary manufacturing instructions, processes, tools, or
equipment; insufficient training; scarce resources, that needs to be reported and tracked
systematically.
12. Contact Us:
If you are interested in a
free demo or want more
information about
Qualityze CAPA
Management Software,
get in touch with our
customer success team on
1-877-207-8616 or write
to us at
info@qualityze.com, and
we will be right there for
you.