PharmAdvice has been successfully advising on almost all GxP issues for 20 years and can draw on 4 decades of professional experience as a pharmacist in the pharmaceutical industry and GMP laboratories.
Involved in the validation of computerized systems since 1986, CSV consulting, auditing and training, validation support, data integrity / audit trail review standards evaluation and upgrades are still a focus of professional tasks today.
Self-developed tools for efficient, time-saving validation, such as a relational validation database and a powerful Excel documentation tool, have been successfully used in validation projects for many years and have also been adopted by well-known pharmaceutical manufacturers and laboratories. A universally applicable VBA-based Excel-GMP module can be integrated into all Excel applications, providing different user access levels, electronic signatures and a GMP-compliant audit trail. Thereby data integrity can be assured all Excel applications including calculations and use as a database, e.g. OOS, CAPA, monitoring and training listings.
The Access-based PharmAdvice training database enables effective GMP-compliant documentation, administration, planning and evaluation of role based training requirements and is used in numerous GMP areas in the pharmaceutical industry, distribution and hospital pharmacies.
With CoviDoc.xlsm, a powerful Excel file has been created for medical doctor'S offices to support documentation, planning, RKI reporting and billing of Covid-19 vaccinations.
The file is also used to train users who want to create GMP-compliant Excel applications themselves and use functions such as VLOOKUP (), COUNTIFS (), complex conditional formatting, data checks, variable names, matrix formulas, sheet and file protection, veryhidden register sheets or want to learn about VBA programming.