Anna Dachs Soler, PhD
AMBIT-BST
Senior Compliance & Digital Transformation Manager in Life Sciences
Anna Dachs Soler is a recognized expert in regulatory compliance, GxP auditing, and computerized system validation (CSV) within the pharmaceutical, biotechnology, and medical device industries. With over a decade of experience, she has led and conducted more than 50 audits across GCP, GMP, GDP, and GVP environments, assessing compliance in manufacturers, CROs, distributors, and pharmacovigilance software.
She has played a key role as a contributor to the second revision of the GAMP Good Practice Guide on validation and compliance of computerized clinical systems and data, as well as the first edition of the GAMP MTP for the pharmaceutical industry. Her expertise in computerized system validation (CSV) and data integrity spans from defining corporate strategies and compliance policies to executing training programs and regulatory assessments.
Anna Dachs Soler is an active ISPE member, contributing to the development of industry best practice guides. Her extensive experience has made her a regular speaker at international conferences, addressing key topics such as regulatory compliance, digital transformation, and validation of critical systems.
She has played a key role as a contributor to the second revision of the GAMP Good Practice Guide on validation and compliance of computerized clinical systems and data, as well as the first edition of the GAMP MTP for the pharmaceutical industry. Her expertise in computerized system validation (CSV) and data integrity spans from defining corporate strategies and compliance policies to executing training programs and regulatory assessments.
Anna Dachs Soler is an active ISPE member, contributing to the development of industry best practice guides. Her extensive experience has made her a regular speaker at international conferences, addressing key topics such as regulatory compliance, digital transformation, and validation of critical systems.