Decentralized manufacturing of Cell & Gene Therapies (CGT) at the Point of Care (PoC) are very complex treatments...
Success Stories
Validation of a Bayesian Multilevel Monitoring System (BMMS)
KVALITO recently supported its pharmaceutical client in implementing and validating their Bayesian Multilevel...
Future Lab – Digital Solution in Pharma Quality Control
This business case describes a project that KVALITO delivered for a Laboratory Information ‘Digital Solution’, which...
ERP Computerised Software Assurance
Validation of computerised systems is crucial. The pharmaceutical, biotech, and medical device industries are subject...
Onsite and Remote IT Quality Audits and Assessments
KVALITO provide expertise in Auditing for Computer System Validation, Data Integrity, IT Security, Quality Management...
Validating Cloud Solutions for Big Data, AI/ML Implementations
With the advent of technology, many organizations are moving towards or adapting technologies like Cloud solutions....
Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends...
Quality in Mergers & Acquisition (M&A) Projects
Mergers & Acquisition is a term that refers to two similar although different topics. Mergers are when two...
Data Migration in the Life Science Environment
Data is one of the most valuable assets in any organization, especially for companies working in the Life Science...
Commissioning, Qualification, and Validation (CQV) for Facility, Manufacturing, and Laboratory Equipment and Systems
Pharmaceutical and Medical Devices KVALITO’s highly experienced CQV Subject Matter Experts perform Commissioning,...
Global Project Management in Regulatory Affairs
KVALITO supports Life Science companies in leading global cross-functional mergers and acquisitions, GMP, Regulatory...
Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends...