THE CHALLENGE
EyeQue was using a file-based system to manage documents and training assessments. They needed a quality management system that would grow with them and that was cost-effective. Their initial goals were to automate document management and to build out a robust training process so they could manage employee training and exams. Going from file-based to an automated quality system, it was imperative to have superior customer support with the right price tag. Compliance adherence was key.
THE SOLUTION
EyeQue successfully deployed Dot Compliance ready to use eQMS to digitize document management and training with integration between existing platforms, including Arena and ZenDesk. They are currently working on a new phase of their implementation to expand the use of Dot Compliance into design control and program management. Since Xpress is based on the Salesforce platform, it will be easy to turn on additional functionality.
BENEFITS
Before Dot Compliance Xpress, training was given using Google Forms. Now it’s administered through the quality system and they have significantly streamlined training procedures and exams. As a medical device company, EyeQue needs to remain compliant with FDA regulations and ISO standards, so additionally, they were able to build a standards library reducing the time it took to search for files.
THE CHALLENGE
Surmasis was managing their document and training management using a paper-based system. Unfortunately, this left them exposed to compliance risks. Other QMS systems previously piloted were not Part 11 compliant or they required advanced training for system administrators and software developers. They needed a simplified electronic quality management system (eQMS) to provide compliance but also visibility into their quality data, real-time, with dashboards and reporting capabilities.
THE SOLUTION
Implementing a pre-validated, off-the-shelf eQMS was their top priority. Dot Compliance’s cloud-based, ready-to-use quality and compliance management system with preconfigured best practices enabled Surmasis to deploy its processes within 30 days and budget. To avoid any customization, they were able to leverage the capabilities of protocols (electronic forms) which added critical data to records without having to generate required fields and revalidate their QMS.
NEXT STEPS
Surmasis continues to take advantage of Dot’s extensive set of quality processes by successfully deploying Changed Control, Complaints, and Corrective and Preventive Actions (CAPA) solutions as well as maintenance activities. Currently, they are working on Electronic Batch Record trials and design. Next on their schedule is to roll out Supplier Quality, Audits, and Quality Events processes.
THE CHALLENGE
Stereotaxis was managing change control processes using a manual paper-based solution. A separate document control solution that was used was not only inadequate for the company’s growing needs but it also was not integrated into the quality and compliance processes.
THE SOLUTION
Dot Compliance QMS Xpress was deployed, and the ease of configuration allowed Stereotaxis to match quality and compliance processes with business requirements. As a result, user adoption was seamlessly rolled out. The company deployed Change Control, Document Control, and Training Management. The solution allowed Stereotaxis to automate the release of controlled documents, create and automate training assignments, and index change controls and documents.
NEXT STEPS
Given the robustness of these processes, the company is looking to expand process automation and move more QMS processes into Dot Compliance
- Complaint Handling
- CAPAs
- Nonconformance Reporting
- Deviations/Waivers
- Vendor Controls
THE CHALLENGE
Unipharm is a leading EU-GMP-certified generic pharma manufacturer with the vast first-to-market record. The company needed to streamline paper-based and semi-automated quality and compliance processes to assure high-quality standards, faster change management, operational efficiency, and business continuity during the COVID-19 crisis.
THE SOLUTION
Project implementation started in early 2020 side-by-side with the health constraints related to COVID-19. A key challenge was ensuring a quick and successful rollout for users working remotely.
Dot Compliance Xpress with a pre-configured core quality process was a great fit for Unipharm’s needs. The rollout process was supported with online training sessions, sample SOPs, data migration tools, and best practices consulting.
THE RESULT
- A fast and efficient rollout, meeting project goals and timelines regardless of COVID-19 challenges.
- 30% Reduction in process time for document control and training
- Improved performance following deployment of automated workflow for document review, approval, content distribution, and training compliance
- 3 Month rollout: Deployed over 10 ready-to-use processes, data migration
- The combination of the Salesforce Platform and Dot Compliance best practices enabled the fast digital transformation of Unipharm’s quality processes
THE CHALLENGE
The company’s quality systems, including procedures, training, and policies, were paper-based. Scientia wanted to eliminate this time-consuming and error-prone manual process.
THE SOLUTION
Scientia was looking for a cloud-based solution that would cover all quality and compliance requirements. It was also critical to choose a solution that was user-friendly, quick to deploy, affordable, and intuitive as well.
They successfully deployed Dot Compliance ready-to-use eQMS to digitize training and deviations within a few weeks.
THE CHALLENGE
TGOD was using paper-based systems to manage quality processes of document management and training assessments. Their process was time-consuming, prone to human error, not in line with their sustainability values, and resulting in less efficient communication. They looked for a solution that would automate and streamline processes while meeting compliance and ensuring data integrity.
THE SOLUTION
- TGOD deployed QMS Xpress and was able to train everyone electronically in a short period.
- Users benefited from access to documents across departments which improved the sharing of information and collaboration.
- TGOD also benefited from the ability to create batch records and find them with a click of a button. The review process is in one place and visible to multiple departments.
- Internal and external Audits were streamlined. Users can now create findings, and CAPAs, set due dates, and ensure compliance. For external audits, they can now link CAPAs and investigations to easily provide to the auditors.
- Customer complaints are now managed from one centralized location, providing visibility into due dates, investigation status, and risk assessments.
BENEFITS
The amount of paper document control has been eliminated. The company can now find documents quicker and more efficiently, saving a lot of time in the process. The chatter function of Salesforce also helped with communication between departments and allowed them to complete documents quickly. Dot Compliance helped TGOD streamline the process of meeting regulatory compliance and ensuring data integrity.