Quality Process Digitalisation & eQMS

Who it is for : Quality and IT teams at regulated manufacturers ready to move from paper to a validated electronic quality system.

What we deliver : *Electronic batch records (EBR) *Electronic document management (EDMS) with compliant electronic signature *Deviation and CAPA management *Incident and non-conformity management *eCRF for clinical trials and validated e-learning platforms *Implementation, qualification and computer system validation (CSV)

Proof : Systems built for data integrity by default, following ALCOA+ principles, with electronic records and signatures aligned to 21 CFR Part 11 and EU GMP Annex 1.

Standards : ALCOA+ data integrity, 21 CFR Part 11, EU GMP Annex 1.