Resources
Assess GxP
Assess GxP’s intelligent assessment wizard guides you through computerised system evaluations, automatically determining regulatory requirements and risk classifications for pharmaceutical and life sciences companies.
Case Studies
Veterinary
CASE STUDY...The organisation wanted to perform GLP studies in non-commercial...
Digital Health
CASE STUDY...A technology company was emerging into the life science...
Company Literature
Presentations
Modernising Quality Systems: Implementing ICH E6 R3 Through Strategic IT Support (RQA May 2025 Virtual Conference)
Articles & Papers
Fractional Auditing in Pharmaceutical Quality Assurance
In the increasingly complex landscape of pharmaceutical research and development,...
The Helsinki Declaration 2024 Update: Advancing Ethical Standards in the Era of Digital Clinical Research
The 2024 update offers important clarifications for pharmaceutical sponsors, clinical...
The Evolving Landscape of Pharmacovigilance IT: Key Considerations for the EU Regulation Amendment
The European Commission’s draft amendment to Implementing Regulation (EU) No...
The evolution of IT Quality and Validation in Clinical Trials – Final part
You can find the final instalment of Matt’s mini series...
The evolution of IT Quality and Validation in Clinical Trials Part 2
You can find Part Two of Matt’s paper here. Part...
Advancing Pharmaceutical Protocols: How ICH M11 CeSHarP Transforms Digital Compliance
The pharmaceutical industry is undergoing a significant transformation with the...
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