Implementation to Operations. We take on all lifecycle stages of compliance management so you can focus on your business.
-
After 400+ projects with 220+ customers; our services, software and methodology are informed by real customer success.
Quality Management Services
We combine insights gained from working with customers who have implemented the same systems, with transparent service delivery and management focused on measurable outcomes.
Strategic Advisory
-
SaaS Governance Model Strategic Implementation
-
Quality Management System Process Harmonization
Computer Systems Validation
-
Pre-Package Systems
-
Validation package
-
Customer-specific Implementation Validation
-
Software release and change management
SOP Accelerators
-
Pre-Packaged Quality SOPS
-
Pre-packaged System SOPs
Audit, Compliance and
Remediation
-
Quality Management System Audit
-
CAPA / Consent Decree Remediation
-
Internal, External and Mock Auditing
Release and Change Management
Maintain compliance and facilitate innovation with a repeatable, reliable and resource-independent solution.
-
Realize the value of your SaaS investment and manage the performance gap.
-
Work with certified product experts focused on compliance.
-
Leverage benchmarks from our work across the industry and mature your processes.
Our methodology brings our services and technology together to make things easier.
-
Transparent services delivery and management.
-
Pre-built validation packages, audit reports and supporting documents.
-
Software that automates customer CSV and Change Management SOPs.
Supported Solutions
Staff Augmentation
We provide you with skilled people who adapt to your needs and follow your business processes.
-
Fully staff teams with precision and efficiency.
-
Individuals with specific skill sets are brought up to speed quickly and make immediate positive contributions to the project.
-
Adapt and increase agility with improved expense clarity.
We do the right thing
We know how to focus on customer success
We deeply understand GxP processes and associated technologies
We have worked in pharma, med-device, biotech, financial services, and tech
We have worked in the US, EU, India, Japan
We are diverse and inclusive