Position your life science product and business operations for commercial success. LuminLogic’s combined consulting and technology solutions work to provide you with a virtual quality management and regulatory department. Our complete Medical Device Document Management System spectrum of quality assurance, regulatory, technology and operational services help medical device, biotech and pharmaceutical companies worldwide.
CAPABILITIES
Regulatory Affairs
Manage Regulated Documents with our Medical Device Document Management System
Regulatory Compliance Software Solution
With LuminLogic, you get an integrated quality and regulatory compliance solution that does more than simply store and organize documents and records. LuminLogic helps medical device, pharmaceutical and biotech companies manage regulated content and key business processes in all phases of product development, including R&D, manufacturing, post-manufacturing and business operations. It provides a 360º view of your quality management system, including standard operating procedures, quality records, critical files and data, so you can meet global regulatory demands such as FDA regulations and ISO quality standards.
LuminLogic is a compliance software solution that gives you a competitive advantage by:
- Facilitating compliance with FDA 21 CFR Part 11 regulatory requirements
- Supporting GMP compliance and Design Controls implementation
- Ensuring post-commercialization compliance by managing complaints and CAPAs
- Determining impact of changes by identifying relationships among documents
- Improving regulatory submission, review and approval processes, so you get to market faster
- Providing workflow and collaboration for regulated data, documents and images
- Supporting faster, more effective control over content used in business communication
- Reducing IT costs with a more flexible, easier to configure system delivered as a service (SaaS).
Add On-Call Quality Support and reap the benefits of working with quality and regulatory professionals who know how to get you up to speed quickly.
Contact us today for a review of your Quality Management Program or to discuss how Quality Management Software can help your company.
CAPABILITIES
Document Management
Regulatory Document Management
Document Control Systems for FDA and ISO Regulations
Medical Device Document Management and Control is essential for effective quality management and a regulatory-compliant system. The demands for effective document management control grow as your product pipeline expands and approaches your commercialization goals. Meet the challenge head on by managing information across your entire operation to ensure FDA and ISO regulatory compliance with:
- FDA 21 CFR Part 11 regulatory requirements
- FDA Quality System Regulation and GMPs
- ISO quality standards
- And other regulatory requirements
LuminLogic empowers you with a central repository for all of your critical business information, so you can:
- Create a searchable library of business and regulatory documents
- Organize and control critical content
- Demonstrate authenticity and non-repudiation
- Improve communication and teamwork across departments and teams
- Lower the cost of FDA regulatory compliance with electronic documents, e-signatures, version control, audit trails and the ability to manage permissions to critical content
Why LuminLogic is the right choice for your document management:
- Successfully validated and inspected in controlled environments
- Dramatically reduces the time it takes to bring a new product to market by accelerating the process for document change, approval, notification and distribution
- Easily configurable Software as a Service (SaaS) tool designed for rapid implementation and validation
- Choose to add On-Call Quality Support services to ensure your medical device or pharmaceutical QMS remains compliant
Document Management features include:
Version Control
Improve document management with automatic revision control to ensure the most current version of your content is easily accessible – with easy to use permissions settings.
LuminLogic tracks all changes in your documents for you!
Solid Audit Trails
Achieve greater success with secure, time-stamped audit trails that exceed 21 CFR Part11 requirements.
LuminLogic records the identity of anyone who creates or modifies an electronic record, when the action occurred and what the changes were – automatically.
Audit trail reports are specifically designed to meet the needs of the most demanding auditor, and the reports are easily modified to meet the auditor’s requests.
Security Features
Store documents in virtual vaults that are only accessible by authorized users.
LuminLogic automatically locks an account when unauthorized users attempt to login or electronically approve a document, supporting 21 CFR Part 11 security requirements.
Analytics and Reporting
Guide mission critical business decisions with advanced analytics and reporting capabilities by using both standard and ad hoc reports.
Electronic Signatures
Sign and approve documents electronically. Signature manifestation – name, date, time, reason and legal intent of the electronic signature – are bound to each document for ultimate security and auditability.
Management of Different Document Types
Successfully manage different documents-based processes and handle all types of documents – regardless of the software used to create them.
Streamlined Communication
Easily create and revise documents as a team with LuminLogic’s collaborative workspace. Avoid duplicating efforts because your team has a 360 degree view of their projects.
Easy-to-Use Reporting Wizards
Build your own custom reports with the easy-to-use Reporting Wizard… no programming needed!
Don’t have time to do all the document management required?
Add Document Management Assistance with our On-Call Quality Support to take the hassle out of your regulatory document management.
Contact the regulatory document specialists at LuminLogic today to get started.
CAPABILITIES
Project and Process Management
Improve Operational Efficiency
Project/Process Management focuses primarily on:
- Cost
- Time
- Scope
- Quality
- Operational Risk
- Collaboration
- Integration
- Human Resources
Improve the way you do business with Project/Process Management tools that give you the right blend of usability and flexibility. Stay informed, control project work, schedules and keep project teams aligned with collaboration and reporting tools that help you manage your business processes.
With robust project and process management tools, you will:
- Determine constraints that drive the start date of a selected task. Easily trace critical paths in projects/process plans to find the root cause of delays.
- Select, preview, print and save the most frequently used information needed to manage projects and processes with predefined reports. Easily track resources, maintain costs and communicate progress with your team.
- Create master templates and easily implement processes that are pre-populated with tasks, critical content and resources. Share templates with other users to create consistency and best practices for your company.
- Maintain a central, secure repository for efficient storage and access to control projects processes, documents, policies and procedures.
Improve communication and teamwork across departments and functional areas.
- Gain enterprise-wide visibility into project statuses with measurable performance metrics.
- Lower the cost of regulatory compliance (such as FDA 21 CFR Part 11) with electronic documents and electronic signatures, version control, audit trails, and the ability to manage permissions to control the access and management of critical content.
LuminLogic’s Project/Process Management Facts
Successfully Validated
LuminLogic Smart Enterprise Suite has been successfully implemented, validated and inspected by regulatory authorities without any instances of non-compliance.
Improve Market Readiness
Dramatically reduce the time it takes to bring a product to market by speeding up the process for document change, approval, notification, and distribution.
Introduce the Ease of Cloud Computing
LuminLogic is an off-the-shelf, configurable product designed for rapid installation, implementation, and validation.
Increase Productivity and Security
Ensures project/process integrity so employees always have the most updated project/process at their fingertips
CAPABILITIES
Quality Management
Quality Management and Compliance Solutions
Have your medical device document management system up and running in minutes with web-based processes and the functionality you need… Not to mention, LuminLogic is validated to ensure regulatory compliance. LuminLogic’s quality management capabilities enable you to:
- Communicate with On-Call Quality Support to ensure your success
- Quickly initiate due diligence management
- Get into compliance fast – and stay there
- Reduce your overall compliance costs and shorten your time-to-market
- Demonstrate authenticity and non-repudiation
- Demonstrate control of your QMS
- Manage complaints and CAPAs
- Report on quality performance
LuminLogic’s Quality Management features include:
Proven Best Practices
Each of LuminLogic’s modules is built around a proven process model and a series of integrated business takes
Validation Readiness
The entire LuminLogic solution is validation-ready, with our best-in-class software development lifecycle.
Developing and maintaining your Quality Management System can be overwhelming. Add Quality Management Support with our On-Call Quality Support to ensure your systems and processes are up to par.
CAPABILITIES
Issue Management
Resolve Issues Quickly
Issue management plays a major role in regulated businesses. Your quality and compliance team must constantly manage non-conformities, exceptions and project deviations. With LuminLogic’s Medical Device Document Management System, you’ll be able to establish and follow consistent procedures for:
- Issue capture
- Loss event tracking
- Task management problems
LuminLogic enables you to:
- Record, review and resolve issues quickly
- Reduce repeat occurrences
- Improve communication on exception cases
- Gain enterprise-wide visibility to the status of issues and incidents
Issue Management features include:
Issue Recording
Take a risk-based approach to quality and compliance management with real-time visibility into issues and incidents. Have instant access to the quality and document management process and its key performance metrics.
Investigation and Remedial Actions
Stop wondering if employees are aware of incidents. Quickly contain the impact of an issue and immediately begin investigation. Benefit from automatic alerts and instant notifications to appropriate personnel when remedial action is required. Having trouble managing issues and incidents? Call to add On-Call Quality Support to your solution and get the answers you need.
CAPABILITIES
CAPA Management
Manage CAPAs quickly
CAPA (Corrective Action and Preventive Action) management plays a major role in regulated businesses. Your quality and compliance team must constantly manage quality non-conformities, exceptions and process deviations. With LuminLogic’s Medical Device CAPA Management System, you’ll be able to establish and follow consistent procedures for:
- CAPA issuance
- CAPA status tracking
- Corrections, Corrective Actions and Preventive Actions management
LuminLogic enables you to:
- Record, review, approve and resolve CAPAs quickly
- Support trend analysis
- Disseminate actions
- Gain enterprise-wide visibility to the status of CAPAs
CAPA Management features include:
CAPA Issuance & Routing
Take a risk-based approach to quality and compliance management with real-time visibility into CAPAs.
Investigation and Remedial Actions
- Stop wondering if employees are aware of non-conformances and associated CAPAs.
- Quickly contain the impact of a nonconformity and immediately begin investigation.
- Benefit from automatic alerts and instant notifications to appropriate personnel when remedial action is required.
Having trouble managing CAPAs? Call to add On-Call Quality Support to your solution and get the answers you need.
CAPABILITIES
Complaint Management
Effectively Manage Complaints
A positive customer experience—and often business success—hinges on how your quality team manages customer inquiries and complaints. This is particularly essential within regulated businesses. With our Medical Device Complaint Management System, your teams can establish and follow consistent complaint-management processes, including:
- Complaint recording
- Complaint status tracking
- Complaint investigation and associated actions
LuminLogic solutions also allow you to:
- Record, review, approve and resolve complaints quickly
- Support trend analysis
- Disseminate actions
- Gain enterprise-wide visibility to the status of complaints
Complaint Management features include:
Complaint Recording & Investigation
Maintain accurate complaint tracking and response, gaining insight into team performance and the customer experience quality.
Investigation and Remedial Actions
- Ensure team members are responding effectively and efficiently to complaints.
- Quickly contain the impact of a complaint and immediately begin investigation.
- Benefit from automatic alerts and instant notifications to appropriate personnel when remedial action is required.
Having trouble managing complaints?
Call to add On-Call Quality Support to your solution and get the answers you need.
CAPABILITIES
Configuration Management
Ensure Design Configuration Management
Design changes are inevitable in any regulated product development, so accurate configuration management is vital. Your engineering and quality control teams must constantly manage product design changes and keep track of associated design history file documentation, including verification and validation activities. With LuminLogic’s Medical Device Configuration Management feature(s), you’ll be able to establish and follow consistent procedures for:
- Design controls
- DHF Index maintenance
- Change-impact assessments
LuminLogic enables you to:
- Maintain design history files
- Trace to consensus standards and effective regulatory requirements
- Determine the impact of a change on all DHF and QMS documents
Having trouble maintaining configuration management?
Call to add On-Call Quality Support to your solution and get the answers you need.
CAPABILITIES
Risk Management
Meet Risk Head On
Every product and process has risk associated with it. By adopting an integrated approach to operational risk management, you can ensure that your initiatives are strategic sustainable processes. LuminLogic supports your Risk Management Program by helping you:
- Document and assess operational risks
- Define controls
- Manage audits
- Implement remediation plans
Dashboards, charts and reports give you visibility into your risk management efforts, and, more importantly, bring high-risk areas into focus. Need help assessing your risk? Our On-Call Quality Support services are just a phone call away.
CAPABILITIES
Content Management
Manage Your Critical Content
With the array of required documentation, regulated businesses drown in paperwork – whether it’s printed or digital. Reduce compliance risks, improve product submissions and increase the speed and quality of product development and manufacturing lifecycles by effectively managing your information. Managing your content is complex and difficult, but a necessity. FDA 21 CFR Part 11 has a broad impact on content, since it affects electronic records, including Word documents, spreadsheets and graphics. A comprehensive content management solution enables you to:
- Share information quickly and easily
- Produce quality business intelligence
- Improve productivity and efficiency
- Operate in a more compliant state
- Reduce duplication of efforts
- Put the right information in hands of the right decision makers
LuminLogic Tames the Information Flood:
Content Consistency
Create intelligent documents that become accurate, consistent templates for regular business operations.
Content Location
Store your data in a trusted centralized location to make finding and sharing information easy. This is critical when your content is subject to regulation.
Content Status
Move and track information from creation, to management, to sharing, to publication and finally to archiving. Easily identify original documents, versions and authorized users.
CAPABILITIES
Collaboration
Breaking Boundaries
Like never before, you can form cross-functional teams, harness expertise and promote best practices across organizational, departmental and geographic boundaries. By providing a knowledge repository equipped with project workspaces, tasks and milestones, LuminLogic enables you to collaborate effectively. LuminLogic connects you with others, giving you the means to:
- Enhance organizational efficiency and agility
- Connect with partners in a single controlled environment
- Capture and leverage the value of collaborative efforts
- Improve business relationships
- Ensure security and reduce corporate risk
- Work more effectively with employees, customers and partners
- Manage projects effectively throughout their lifecycle
Collaborative features include:
Ideation Tools
Enable ideas and projects to launch quickly with its built in wizards and content creation templates.
Knowledge Base
Leverage expertise with member profiles, expert designations, FAQs and threaded discussions.
Collaborative Workspaces
Reduce ramp-up time and project lifecycles by providing all members of your company or department with access to a secure, web-based project workspace and content repository.
Easy-to-use Reporting Wizards
Monitor due dates, milestones, tasks and priorities, and generate status reports, which are automatically provided to management.
CAPABILITIES
Auditability
Pharmaceutical and Medical Device Company Audits
Audit Management Software Solution
In the world of regulated businesses, it’s not a matter of “if” your quality system will be audited. It’s a matter of “when.” LuminLogic takes the stress out of audits by providing an audit management software solution. Attain and maintain compliance by automating, streamlining and managing the audit process and meeting the demands of the auditor.
FDA Audits are conducted to ensure your business is operating in a way that supports the approved use of your products, as well as the maintenance and improvement of product quality and safety. Audits by sponsors and partners are conducted to ensure that you will be able to support their regulatory obligations.
LuminLogic’s reports help collect and track data to streamline the audit process by:
- Identifying when a document was created, modified or deleted
- Capturing changes made to a document
- Tracking who made modifications
- Recording date and time changes were made
- Requiring the person who made the change to provide a reason for modification
- Providing custom audit trail reporting with print, save and export options to meet the precise need of the auditor
- Including 21 CFR Part 11 compliance features
Preparing for an audit is a daunting task. Add On-Call Quality Support to your solution to help you achieve a successful audit.
Contact us today to learn how LuminLogic can be your audit management software solution.
Sign Up for a Free Demo
Connect with one of our regulatory software experts to get a live demo of Methodsense’s LuminLogic in action. We’ll show you how easy it is to use, as well as how it works to support the regulated environment your business supports.