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.
What if a customized and scalable QMS building framework existed? One that:
Keeps up with business, technical and regulatory changes
Fulfills the requirements of GxP regulations — by design
Manages data throughout the product development lifecycle
Automates data collection, analysis, and reporting across the organization
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.
Here’s how we can elevate your QMS
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
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
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
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