“TrackWise solves a lot of problems that we have. Having an integrated quality management system, at the same time good reporting structure, good dashboards, and query management in such a way that we can get answers to all our metrics and management reviews. They understand what we need, and they come up with a solution to that.”

The post Voice of Customer: Suruchi Sharma, Regional Quality Manager @ Abbott | Experience with TrackWise Quality appeared first on Honeywell.

“TrackWise helped us to implement all the modules easily along with required IT infrastructures and helped us to harmonize the process across sites.”

The post Voice of Customer: Jagdish Meghrajani, Senior Manager IT @ Zydus, | Digital Transformation Journey with TrackWise QMS appeared first on Honeywell.

This process is applied to ensure that changes in a system or product are controlled, coordinated and approved before their implementation.

Here’s why it’s needed.

The Importance of Change Management

To prevent issues associated with changes to processes and procedures, systematic controls must be put in place. For any company with a complex manufacturing process, systems must be established to evaluate changes and to track them. This ensures adequate control.

Change management is critical because:

• Every modification to a process, material or equipment needs to be properly recorded and authorized
• It ensures proper coordination across stakeholders through automated workflows and alerts
• It helps meet compliance with industry and government regulations and standards

Change management ensures the safety and quality of medicines are not compromised by production and process changes. With the lives of consumers at stake, product irregularities simply cannot occur.

Challenges Facing Manual Change Management

There are various types of changes that can trigger the change control process, including changes to documents, regulations, equipment and materials.

The vast and complex nature of change control procedures has caused many companies to struggle with implementing a global change management system.

As a result, many manufacturers instead use a collection of disparate manual systems, spreadsheets and databases. These manual, disconnected mechanisms can lead to delays, input errors, inconsistencies, duplicate data and loss of productivity.

Benefits of Automating Change Management

An automated change management system manages all action items associated with a change including impact assessments, implementation items, regulatory notifications, approvals and effectiveness checks. It reduces risk by enforcing a consistent and harmonized change control process that is compliant with industry regulations.

Organizations will also see an improvement in efficiency and reduction in change management closure time by automating workflows and implementing an electronic parallel review and approval process. Furthermore, the process reduces risk of lost or duplicated data by enforcing a consistent and harmonized change control process.

3 Best Practices to Follow for Effective Change Management

Change management is a critical business issue in terms of risk, safety and business performance. Successful implementation of an enterprise-wide global change management program will:

• Improve cycle time and time to market
• Enhance production
• Increase product quality
• Enable flexibility needed to adapt to changing regulations

There are three best practices companies can apply that will provide an effective change management system—automation, centralization and integration.

View the eBook to learn more about these best practices and learn how they can transform your change management process.

The post Take the Fear out of Change with an Automated Change Management Process appeared first on Honeywell.

These 20-minute sessions included quick demos of each quality process area using TrackWise Digital and live Q&A with a solutions engineering expert.

The post TrackWise Digital Success Series: An Overview of Key Processes appeared first on Honeywell.

In a previous article, we talked about the challenges to effective quality management, including use of siloed or homegrown systems.  But quality doesn’t have to be hard—in fact it shouldn’t be. With solutions pre-packaged to fit the needs of regulated industries, it isn’t.  

A good quality management solution is intuitive, simple to use and encourages user adoption. This is the basis of Sparta’s Quality Process Accelerators (QPA), which can help streamline and speed up your path to quality.  

Backed by Industry Experience and Influence   

Your organization can simplify and standardize your quality management processes with Sparta’s QPAs. Sparta’s intelligent, pre-validated quality processes are built on almost three decades of industry best practices. Our leading processes are backed by decades of feedback from customers and regulators—in short, we know the industry and the quality drivers your organization needs to be successful.  

Related article: FDA raising quality technology expectations

Plug and Play: Achieve Rapid Time to Value  

With Sparta’s QPAs, you can get your system up and running quickly, resulting in rapid time to value. This process standardization and simplification drives significant value and time savings for the end user.  

Simplicity in a Digital Quality Solution 

Our QPAs, developed in conjunction with Sparta’s Quality Best Practices Council, assure that change is managed at both the site and corporate and global level, with the appropriate personnel involved in change assessment, planning, approval, implementation and deployment. 

Sparta’s QPAs include: 

• Nonconformances: The nonconformance QPA records data about situations in which a product or device has not conformed to standards. This provides insight into which devices don’t conform, how they go against standards, where they are produced and how customers are impacted. It enables users to identify, record, assess and investigate deviations and nonconformances in a consistent and harmonized process.  

• Corrective and Preventive Action (CAPA): Complaints, audits and adverse events often lead to compliance events that must be addressed through a company’s CAPA process.  The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.   

• Audit Management: The audit management QPA helps companies monitor critical processes, identify gaps and improve quality. This solution drives efficient management of resources, workflow, data and records associated with company internal audits of all levels as well as with audits relevant to suppliers and company regulatory inspections. This process allows manufacturers to take a best practices approach to compliance and risk management.  

• Change Management: The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected. It enforces a standardized change control process across the enterprise while allowing the flexibility to meet specific workflow steps, making it the only solution designed to be flexible enough to manage all types of changes using one centralized system. 

• Out of Specification: Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA. OOS records contain information on situations when lab results come back out of the range in which they were expected. 

• Intake:  The intake QPA enables users to capture critical information using a simple, browser-based interface and share it with quality and compliance teams from anywhere, on any device.  

• Extension Request: Use the extension request QPA when a time-sensitive record cannot be completed on time. It contains information on the record, the original due date, a suggested new due date and reason for the delay. 

• Quality Events: Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues. Quality events contain information on an event that has occurred regarding the quality of a product, as well as the actions that should be taken to minimize the negative impact of the event.  

• Batch Release:  The batch release records contain information on a grouping of products that are being manufactured together. 

• Complaint Handling: Track, triage, escalate and share records in a centralized and validated platform. The complaint handling QPA provides the ability to log, respond to and investigate complaints. It enables monitoring of developing trends through integrated tracking and reporting.   

• Risk Management: Risk Management enables companies to seamlessly link the risk process to other quality management processes. It facilitates the implementation and maintenance of a risk management program in accordance with ICH Q9 and ISO 14971. 

• Supplier Quality Management: Effectively manage and collaborate with suppliers and contract manufacturers across your supply chain. Supplier quality management allows quality teams to manage supplier relationships from onboarding to auditing and scorecard analytics. 

• Product Registration Tracking: Product Registration Tracking (PRT) significantly reduces the time, cost and resources needed to track product submissions with regulatory agencies around the globe.  

Sparta’s QPAs help simplify the process of quality management and drive success for regulated industries. Start improving productivity and reduce the chance of errors by enabling quality teams with the best practice processes, automation and collaboration that a digital quality management solution provides.  

Interested in learning more?  Request a demo and see firsthand how Sparta’s QPAs can benefit you.   

The post Simplify and Standardize: The Power of Quality Process Accelerators appeared first on Honeywell.

Efficient and effective change management has never been more critical in life sciences, as the global needs for expanded access to medicine and medical products has grows exponentially.
 
In fact, many organizations are winning the battle against the novel coronavirus by changing themselves to better meet the needs of patients, consumers, healthcare providers and workers.
 
Digging into their core competencies and capabilities, many companies and organizations are answering the call to aid, from whenever it can be sourced.

• Some are changing manufacturing capacities to increase production of ventilators and other critical devices.
• Some are developing and transferring rapid test kits to identify COVID-19.
• Others still are working on vaccines and medical therapies for patients already infected with COVID-19.

Managing change under the best of circumstances is a complicated cross-functional process that requires significant administrative efforts to assure that change control rigor scales with change risk and significance.
 
While there is a business imperative to implement change rapidly in the face of external challenge, there is even greater need to make sure that change is appropriately planned and vetted and controlled. The current global pandemic should prompt all businesses to be lean where permissible without increasing risk to business and supply chain.

TrackWise Digital enables rapid change implementation so your organization can focus on responding to the needs of patients and healthcare workers.

• TrackWise Digital enables rapid change implementation so your organization can focus on responding to the needs of patients and healthcare workers.
• Our Quality Process Accelerator, developed in conjunction with Sparta’s Quality Best Practices Council, assures that change is managed at both the site and corporate/global level, with the appropriate personnel involved in change assessment, planning, approval, implementation and deployment.
• TrackWise Digital Mobile delivers change control tasks directly to the hand of key stakeholders, providing a comfortable user interface for remote change management.
• TrackWise Digital’s integrated dashboards and reporting make sure the entire enterprise organization is aligned and aware of current information.

For life sciences organizations that are looking to contribute to the global fight against the novel coronavirus, and an expanded QMS function could increase your speed and scale, as you serve the world’s needy, please reach out to learn more about TrackWise Digital.

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