Sanitization Audit Software for Effortless Global Compliance

Cleaning Validation is SYNCOMX's cleaning validation software that automates HBEL-based residue limit calculations, worst-case product identification, and validation protocol generation. It eliminates manual spreadsheets and ensures consistent, defensible cleaning validation documentation.

When new products are introduced or processes change, Cleaning Validation automatically re-evaluates all product-equipment combinations, recalculates MACO limits, identifies new worst-case pairs, and flags any validation gaps that need to be addressed.

Yes, Cleaning Validation fully supports HBEL (Health-Based Exposure Limit) methodology as recommended by the EMA and FDA. It calculates ADE/PDE-based limits and applies them to determine maximum allowable carryover for all products.

Absolutely. Cleaning Validation auto-generates complete validation protocols, cleaning verification reports, and change assessment documentation that meet FDA, EU GMP, and other regulatory standards for audit readiness.