Decentralized manufacturing of Cell & Gene Therapies (CGT) at the Point of Care (PoC) are very complex treatments...
Success Stories
Business Case: Validation of a Bayesian Multilevel Monitoring System (BMMS)
KVALITO recently supported its pharmaceutical client in implementing and validating their Bayesian Multilevel...
Business Case: Future Lab – Digital Solution in Pharma Quality Control
This business case describes a project that KVALITO delivered for a Laboratory Information ‘Digital Solution’, which...
Business Case: ERP Computerised Software Assurance
Validation of computerised systems is crucial. The pharmaceutical, biotech, and medical device industries are subject...
Business Case: Onsite and Remote IT Quality Audits and Assessments
KVALITO provide expertise in Auditing for Computer System Validation, Data Integrity, IT Security, Quality Management...
Business Case: 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....
Business Case: Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends...
Business Case: Quality in Mergers & Acquisition (M&A) Projects
Mergers & Acquisition is a term that refers to two similar although different topics. Mergers are when two...
Business Case: 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...
Business Case: 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,...
Business Case: Global Project Management in Regulatory Affairs
KVALITO supports Life Science companies in leading global cross-functional mergers and acquisitions, GMP, Regulatory...
Business Case: Automation of Software Development Life Cycle (SDLC)
Automation of Software Development Life Cycle (SDLC) FDA's Center for Devices and Radiological Health (CDRH) intends...