Who is the eTMF Health Check For?
Our eTMF Health Check is the perfect service for eTMF Managers, System Administrators, and Owners who want to make the most out of their eTMF investment.
Revitalize Your eTMF with Advanced Optimization Strategies
The eTMF Health Check from Daelight Solutions is a joint system and process review of your organization’s eTMF configuration and usage. This evaluation considers business needs, industry best practices, and regulatory requirements regardless of what eTMF system you use.
You can also deploy the eTMF Health Check to review your partnered technology and ensure compatibility with your processes and expectations. Click below to fill out our short questionnaire and get a customized Health Check based on your answers.
Assess Your eTMF in 2 Stages
Your eTMF is unique, which means there’s no one-size-fits-all approach to improving its performance. That’s why our experts analyze your eTMF in two distinct stages. With a better understanding of your system’s operations, we can provide actionable recommendations to boost functionality.
Stage 1: eTMF System Analysis
Is your eTMF operating effectively? If you aren’t sure, we can help by looking over your current performance. Here’s how we do it:
- Assess current state deployment against best practices
- Analyze metrics and reporting usage
- Identify areas of automation
- Review feature use and recommend best practices
- Identify methods to increase user adoption
- Identify areas for efficiency gains
Stage 2: eTMF Process Analysis
Next, we will review your eTMF process and look for ways to streamline operations. This comprehensive analysis involves:
- Check utilization of approved SOPs
- Review Quality Review Processes and identify ways to reduce complexity and resource burden
- Review change and release management processes
- Evaluate user administration practices
- Identify areas for process simplification
Benefits of the eTMF Health Check
Our eTMF Health Check offers several advantages for your system and process:
- Improve the performance and reliability of the eTMF system
- Increase user adoption of the eTMF system
- Improve the efficiency of eTMF management processes
- Enhance regulatory compliance
Post-Health Check
Your partnership with Daelight Solutions doesn’t stop with the eTMF Health check. The Daelight TMF Services Team applies deep knowledge of regulation and best practices across the TMF Management space.
Our team of experts can assist you from start to finish, from system implementations and document processing to technical migrations, inspection readiness checks and system administration. The TMF is the story of your clinical trial; make sure it’s ready to tell.
TMF Toolkit
Utilize our tools and templates to stay compliant and set yourself up for success.
TMF Expertise on Demand
Partner with our TMF experts to oversee your TMF management practices when needed.
System Implementation and Migration
Setting up and moving to a new eTMF is easy when you work with our team.
System Administration
Let us manage your eTMF throughout all stages of deployment and maintenance.
Who is Daelight Solutions?
Daelight Solutions is an IT consulting company that is relentlessly focused on meeting the enterprise information challenges faced by companies in the pharmaceutical, biotech and medical device industries. We combine strategic experience and technical expertise to deliver meaningful results and value for clients.