Connect regulatory and quality processes with better information
Regulatory and quality teams work across submissions, compliance activities, audits, CAPAs and information held across multiple systems and documents.
Megnity helps connect Salesforce, data and AI around these processes so teams can find information more easily, manage workflows and maintain the controls their environment requires.
Connected information
Bring regulatory information together
Regulatory work can involve information spread across documents, systems, teams and processes.
We help connect relevant information and workflows so teams have better visibility into what is available, what needs attention and what happens next.
The aim is to make information easier to work with without creating another disconnected process.
- Documents
- Systems
- Teams
- Processes
Better visibility
- What is available
- What needs attention
- What happens next
Submissions
Support submission processes
Regulatory submissions can involve significant amounts of information, coordination and review.
We help connect the workflows and information around submission processes so teams can manage activities and handoffs with better visibility.
AI can support information-heavy tasks where appropriate, while people remain responsible for review and regulatory decisions.
Audits
Make audits easier to manage
Audit activities can require teams to gather information, coordinate responses and track actions across different parts of the organization.
We help connect the information and workflows around audits so teams can understand what needs attention and manage follow-up activities more consistently.
Clear ownership and traceability can remain part of the process.
CAPA
Connect CAPA workflows
Corrective and preventive actions can involve multiple people, reviews and follow-up activities.
We help connect the information and workflow around CAPAs so teams can track actions, responsibilities and progress more clearly.
The process can be adapted around the organization’s existing quality systems and ways of working.
- Actions
- Responsibilities
- Progress
GxP controls
Keep GxP requirements in the process
Technology used in regulated Life Sciences environments may need to operate within GxP requirements.
We treat validation, traceability, access, approvals and other appropriate controls based on the process and environment in which the solution will be used.
Where validation is required, it can be incorporated into the delivery approach.
Explore validated GxP deliveryHuman oversight
Use AI with human oversight
AI can help teams find, organize and summarize information, particularly where processes involve large volumes of documents or repetitive information work.
We identify specific tasks where AI can support the team while keeping review, judgment and approval with the appropriate people.
The level of human oversight can be designed around the needs and controls of the process.
Explore AI and agentsControlled data
Connect data without losing control
Regulatory and quality information becomes more useful when teams can access the right data without compromising the controls around it.
We help connect relevant data across systems and workflows while considering access, traceability and governance requirements.
The architecture can build on the organization’s existing platforms and data environment.
Explore data engineering and analyticsTechnology
Technology that supports regulated processes
We work across Salesforce, data, AI and integration technologies based on the process, existing systems and regulatory environment.
The goal is to connect technology around the way teams work while maintaining the appropriate controls.
Explore our platforms
Contact
Looking to improve your regulatory and quality processes?
Tell us where information, reviews or handoffs are creating unnecessary work for your teams. We’ll help you identify where Salesforce, data and AI can support the process while keeping the right controls in place.
Talk to our Life Sciences team