SERVICES
Quality and Regulatory Consulting
Customer Support Services

If you’ve come here looking for help, you’re in the right place. If you don’t find the answer to your questions here, give us a call. LuminLogic’s Technical Support Team will help you with detailed, accurate support… on the first call. Do you need quality or regulatory expertise? Add On-Call Quality Support services for help solve your compliance challenges.

If you are just getting started, looking for our latest resources, or interested in our product, check out our support services and tools. To get in touch with one of our product experts instead, simply reach out to us by phone or email. We’re ready to help.

Consulting

Satisfy US and global authorization requirements

On-Call Quality Support

Manage product quality and safety requirements

Training

Achieve product quality standards and operational efficiency

Validation

Minimize risk with compliant business and product technologies

Implementation

Meet quality standards to bring your product to market internationally
SERVICES
Consulting
Our Expertise, Your Business, Proven Results

When you implement with LuminLogic to address compliance and quality management needs, you benefit from the additional support of an On-Call Quality Support professional to answer your questions. We’ll help you review your documents to ensure your set up for success.

When you have more in depth needs, we’ll put you in touch with regulatory consultants from MethodSense.

MethodSense, the parent company to LuminLogic, is a life science consulting firm with offices in the US and Europe. Their expertise, first-hand knowledge and passion help you get going fast, and keep you going strong!

They ISO 13485 Quality Management System provides a complete spectrum of quality assurance, regulatory, technology and operational services to medical device, biotech and pharmaceutical companies worldwide. Consulting for global compliance needs includes:

Regulatory Affairs
100%
Quality Assurance
100%
Quality Certification
100%
Safety Testing & Certification
100%
Technology Management
100%
Business Operations
100%

For a proven way to reduce risk and costs, get fast results and get the most from LuminLogic, trust our team to guide you.

SERVICES
On-Call Quality Support
Maintain Compliance With Quality Support
Quality Support When You Need It

On-Call Quality Support is a unique pairing of our software – with all its controls – and our expertise as quality and regulatory consultants. For a proven way to reduce risk and costs, get fast results and get the most from LuminLogic, trust our team to guide you.

We know firsthand that the most difficult aspect of compliance is maintaining it. Every year. Every month. Every week, there are actions that must be taken to demonstrate you’re in compliance with your ISO 13485 Quality Management System. When you’re not compliant, or can’t demonstrate that you’re in compliance, you could face lost opportunities and costly setbacks.

Without On-Call Quality Support, you’ll be asking questions like:

  • What if our company is audited tomorrow?
  • What if a potential partner can’t see how we’re managing our business?
  • What might noncompliance cost us?

With LuminLogic as your solution, you benefit from the additional support of an On-Call Quality team to prepare, review and maintain your documents and records, ensuring you’re set up for success. When you have more in depth needs, we’ll put you in touch with regulatory and quality assurance consultants from MethodSense, giving you the complete resources you need for operational success!

Minimize Risk: Get On-Call Quality Support to Maintain Compliance

Demonstrate that you're in compliance by fulfilling what you said you would do in your Quality System!
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Quality Support

When You Need It

SERVICES
Training
Training to Maximize Success

Trained employees mean higher user adoption rates. Help your employees be more productive by giving them the training they need to be successful. LuminLogic’s training programs empower your employees to effectively support your organization by:

  • Reducing the risk of non-compliance
  • Reducing the cost of quality and safety
  • Protecting your most valuable asset: Intellectual Property

Our customized training sessions are designed specifically for your solution and offer:

  • A functional overview of the software
  • Instruction directly related to your regulatory and operational needs
  • Detailed practice of the your set up and processes
  • Custom training programs for specific learning requirements

Train users at LuminLogic’s facility or in instructor-led virtual classes. We’ll even come to you to train your entire team!

SERVICES
Validation
Software Testing & Validation

Life Science product commercialization increasingly incorporates technology solutions that are subject to regulatory review. This includes solutions that support your business operations, like LuminLogic.

LuminLogic maintains current Hardware / Environment Installation Qualification for all ASP Model clients as part of our best-in-class Software as a Service offering. We comply with ISO 9001, and our software lifecycle development meets Carnegie Melon Software Engineering Institute’s Capability Maturity Model Level 3 requirements.

Additional optional validation services include:

  • Hardware / Environment Installation Qualification Development (Hardware IQ)
  • Software Installation Qualification (Software IQ)
  • Operational Qualification / Performance Qualification (OQ/PQ)

Validation support can be bundled to include test scripts, documentation, training, configuration and assistance in execution.

SERVICES
Implementation
Compliance is within your Reach

Ready to implement the right document management solution for your company? With both our Smart Enterprise Suite and Smart Solutions, we’ll manage your installation, and perform a Software Installation Qualification (Software IQ) at your request. The Software IQ becomes part of your files, demonstrating that the solution was properly installed to support its intended use.

We begin the installation process by asking targeted questions to uncover requirements specific to your business. We discuss your operational practices, areas that need improvement and features you’d like. From there, we help you:

  • Determine which solution will be the best fit for your regulated business
  • Plan for data migration and integration
  • Set up a secure environment
  • Design an effective document management infrastructure
  • Create data management practices to ensure trusted data quality
  • Develop reporting capabilities

Because everything is based in the cloud, you’re free of the confines of hardware upgrades and traditional software challenges.

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