Data Integrity
Data integrity encompasses several key principles, including completeness, accuracy, consistency and authenticity.
In pharmaceutical Computerised System Validation (CSV), ensuring data integrity is essential for guaranteeing that electronic records and signatures are dependable and reliable, while also following regulatory standards, such as those detailed in 21 CFR Part 11 and Annex 11 of the EU GMP guidelines.
This is paramount for upholding the integrity of vital data on manufacturing processes, laboratory testing, clinical trials and pharmacovigilance endeavours.
Trusted by top-tier teams worldwide
Our data integrity services include:
- Data Integrity Assessments
- Policies & Procedures Framework
- Training for your organisation
Featured case studies
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…
Tech Transfer
Tech Transfer (COVID-19 Vaccine) Introduction Worldwide Vaccine Manufacturer British-Swedish multinational pharmaceutical and biotechnology company. Areas Oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. Apotech Consultants The Apotech Consultants were embedded in the client’s global TechOps team. This team consisted of ~50 people, spread across the globe, and our consultants reported to the Director of Global…
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…