“ABF-Pharmazie aims to work paperless in their processes and thus, TrackWise Digital fits quite well in this digital strategy. We knew that we set up GMP compliant processes when we chose TrackWise Digital.”

Julia Cieplik, Deputy Head of QA and TrackWise Digital System Administrator, ABF-Pharmazie

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

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Most Life Sciences companies have adopted two types of electronic solutions—quality management systems (QMS) and DMSs. Both systems play an important role, but they can create new barriers to quality if they operate independently.

The highest functioning quality programs integrate their quality management and document control processes. In doing so, they maximize the effectiveness of both solutions, provide greater transparency and create stronger collaboration around quality. 

Mitigating Quality Management Complexities  

To effectively manage quality, leaders must track and control an intricate web of quality events, any one of which could trigger numerous parallel or downstream actions. Digital QMS tools are more effective at managing quality activities, enabling faster business processes by enforcing and automating workflows, faster critical processes and meeting regulatory compliance with record retention.

An increasing number of Life Sciences companies are now leveraging advanced capabilities, like machine learning and natural language processing, so quality events and complaints can be processed accurately. 

A Better Approach to Document Management  

Governing bodies have strict standards on how quality measures are both performed and documented. As a result, document management is just as complex as managing quality. A DMS needs to allow for the complexity Life Sciences companies must adhere to and yet be user-friendly. To manage the complexity, Life Sciences companies need a document management strategy that can address a standard and repeatable protocol for creating and revising documents, roles, ownership and access to documents in varying stages. They also need a solution that will provide security throughout a document’s lifecycle and enable them to prevent or recall rogue or outdated documents.

The Power of Integration  

Integrating quality management and document management offers numerous benefits, including improved processes and efficiency, helping to meet compliance with regulations, increased customer satisfaction and enhanced collaboration.  

This holistic approach ensures that organizations are better equipped to respond to changing market conditions and make informed decisions. 

Bridging the Gap between Quality and Document Management 

Life sciences companies require digital tools that can match the complexity and scale of their quality management operations. Modern solutions are flexible enough to meet various quality and documentation requirements, enabling efficient and effective execution. By integrating quality tools such as QMS and DMS, these systems can enhance each other, improving performance, meeting compliance, providing better visibility and minimizing risks. 

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One solution to this challenge is to implement an integrated approach to quality, leveraging technology to improve compliance and efficiency. 

Document Management 

One of the key components of an integrated approach to quality is document management. Document management technology can help manufacturers automate the process of creating, reviewing, approving and storing documents. This can help to reduce the risk of errors in the manufacturing process and ensure that all necessary documents are readily available for review by regulators. 

Additionally, many regulators, such as the FDA, now accept electronic submission of documents. Document management technology can help manufacturers prepare and submit these documents electronically, making it easier to submit the documents in a timely manner. 

Auditing and Tracking 

Another important component of an integrated approach to quality is the ability to track and audit changes made to documents. This can be useful during a regulatory review as it allows manufacturers to demonstrate that documents have been reviewed and approved by the appropriate personnel and that any changes made have been properly documented. 

Secure Storage 

In regulated industries, manufacturers must ensure that sensitive information is stored securely. Document management technology can help manufacturers to store documents securely, protecting sensitive information from unauthorized access. 

Reporting 

An integrated approach to quality should also include the ability to generate reports that can be shared with regulators. Reports can include information on the approval status of documents, changes made to documents, and compliance with regulations. 

Meet Compliance and Reduce Risk by Taking an Integrated Approach to Quality  

An integrated approach to quality, leveraging technology to improve compliance and efficiency, is essential for manufacturers in regulated industries. Document management technology, auditing and tracking, secure storage and reporting are key components of this approach. By implementing these solutions, manufacturers can meet compliance and reduce the risk of errors in the manufacturing process. 

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• Compliance: The use of document management technology can help manufacturers in regulated industries meet regulatory compliance by automating the document management process, making it easy to create, review, approve and store documents. This can help to reduce the risk of errors in the manufacturing process and ensure that all necessary documents are readily available for review by regulators. 

• Electronic submission: Many regulators, such as the FDA, now accept electronic submission of documents. Document management technology can help manufacturers prepare and submit these documents electronically, making it easier to submit the documents in a timely manner. 
• Auditing and tracking: Document management technology can also help manufacturers to track and audit the changes made to a document. This can be useful during a regulatory review as it allows manufacturers to demonstrate that documents have been reviewed and approved by the appropriate personnel and that any changes made have been properly documented. 
• Secure storage: In regulated industries like pharmaceuticals and medical devices, manufacturers need to ensure that sensitive information is stored securely. Document management technology can help manufacturers to store documents securely, protecting sensitive information from unauthorized access. 
• Reporting: Document management technology can also help manufacturers to generate reports that can be shared with regulators. Reports can include information on the approval status of documents, changes made to documents and compliance with regulations. 

Overall, document management technology can help manufacturers in regulated industries manage and control their documents more effectively, making it easier to comply with regulations and demonstrate compliance to regulators during inspections and audits. 

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Arbor is a virtual pharmaceutical manufacturer with over 40 contract manufacturing organizations (CMOs) and more than 400 change control records per year. The company relies on its quality management system (QMS) to streamline document approval and storage for improved stability control. 

Mikart, a recognized CDMO leader since 1975, provides pharmaceutical development, contract manufacturing, and packaging services to virtual and midsize pharma/biotech companies offering state-of-the-art technology and expertise. The company underwent a digital transformation initiative that included a fresh look at quality management system needs.  

The Need for a Change  

Both companies were looking for a solution for creating, reviewing, approving and storing documents, while also ensuring that they were easily accessible to those who needed them. 

They found the solution they were looking for in TrackWise Digital. One of the key challenges that Arbor Pharmaceuticals was facing was using an approach that combined a manual, paper-based change control system with a resource-intensive document management system.  

Mikart was looking for technology that would shift quality from being paper-based to digital. Too much time and human capital was being spent on routing documents for approvals and signatures, by foot, across their sites at their sprawling, multi-building campus.  

Reaping the Benefits  

With TrackWise Digital, Arbor and Mikart were able to automate their document management processes, making it easy to create, review, approve and store documents.  

Arbor’s users now access TrackWise Digital daily to review and approve documents. And those workflows now look quite different. As a result, Arbor has been able to improve both timeliness and efficiency.  

For Mikart, TrackWise Digital has provided a secure and central repository, accessible by mobile phone and an approval process that could have taken 2-3 days now can take place in less than a day.  

Simplifying Document Management with TrackWise Digital 

These two case studies highlight the challenges that companies can face when it comes to document management in the pharmaceutical industry. Both Arbor and Mikart were able to improve document management while integrating it with their overall quality management processes using TrackWise Digital. 

So what do they have to say about the results?  

“When people have questions now, they’re usually about internal procedures — not how to use the QMS software,” says King. “I don’t think anyone would choose to go back to the old system now. TrackWise Digital makes life easier. I only wish that all of our CMOs were using it.”  

Quality Operations Analyst at Arbor  

“It would take two to three days to get an investigation approved, running a document from site to site, person to person. In TrackWise Digital, it can go to everyone at once, throughout the buildings, even if they’re working from home, or taking a business meeting in a different state.” 

Director, Quality Operations at Mikart  

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