Expertise

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Connect, organize and visualize your QMS data to see the big picture

Accelerate product development and unlock potential with powerful digital tools that connect your data, workflows, and teams.

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What if a customized and scalable QMS building framework existed? One that:

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Keeps up with business, technical and regulatory changes

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Fulfills the requirements of GxP regulations — by design

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Manages data throughout the product development lifecycle

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Automates data collection, analysis, and reporting across the organization

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We thought it through and built a QMS framework with a simple goal in mind:

To empower quality and regulatory leaders in life sciences to make faster and more accurate GxP decisions through the product development lifecycle.

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our services

Here’s how we can elevate your QMS

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QMS Design and Build

Organizations get to choose their approach to documentation unless they decide to take the easy way out and mirror a cookie-cutter approach suggested in a standard. With our creative technical writing skills, every QMS document and record in your company will be simple, easy to train on, and compliant with regulations.

Document management (Process, System, Equipment)
GxP training
Quality risk management
Automating quality process workflows
Building custom metrics and analytics
Quality events (Change Control, CAPA, Deviation)
Supplier management
Audits and inspections management

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Computer Software Assurance

We specialize in implementing GxP-compliant computer systems with speed and agility by leveraging supplier documentation to the fullest extent. Our systems expertise spans all GxP areas, including manufacturing systems, quality systems, laboratory tools and equipment, clinical trials software, patient data repository, drug safety database, ERP, and supply chain systems.

Risk-based validation strategy
Authoring system specifications
Regulatory and risk assessments
Software testing strategy
Test script authoring and automated software testing
Continuous validation
Release management and system administration

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GxP Regulatory Compliance

Our team of certified quality assurance and regulatory affairs professionals can provide process oversight to ensure your operations comply with internal policies and global regulations from US FDA, EU, and other region-specific requirements.

Internal and external audits (Software, Process, and Equipment)
Gap analysis and GxP regulatory assessments
Audit and inspection observation responses
Quality records management and oversight
Process alignment to regulations and industry standards

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Data Integrity and Governance

Data management is critical to ensure GxP data integrity and to avoid unacceptable risks to product quality, patient safety, and public health. Our team will help you build a data governance model from the ground up to ensure all GxP data is recorded, processed, retained, and used to preserve the integrity and quality of the data.

Process flows and data mapping
Data integrity risk assessments
Data management (operational and master data)
Audit trails and user access controls
Backup, archival, and records retention
Building data lakes and data dictionaries