Chemical-Pharmaceutical

Management: WFI loop, loop PWS, treatment, dosing of powders and liquids, mixing, CIP, packaging lines, palletizing, purification (suppositories, tablets, pills).

Technical support and development of the necessary documentation to the validation of the process of validation plans and protocols (DQ, IQ, OQ).

Quality Plan / Functional Specifications / Project Specification Hardware / Software Project Specification / Factory Acceptance Test / Site Acceptance Test / Installation Qualification / Operational Qualification.

Supply control systems for new plants and for the revamping of existing installations:

– Dosage / STERILIZATION / TREATMENT / SANITATION;

– DISTRIBUTION H2O / SOFTENER / FILTER.

21 CFR: PART 11 – DATA SECURITY

Access Management user with security policies conform to “21 CFR: PART 11” – Food and Drug Administration.

The documentation for validation:

Quality Plan

Functional Specification

Hardware Design Specification

Software Project Specification

Factory Acceptance Test

Site Acceptance Test

Installation Qualification

Operational Qualification

More info

Inquiry for product: Chemical-Pharmaceutical

Your name (required)

Your Email (required)

Phone

Your Message

Consenso al trattamento dei dati personali resa ai sensi dell'art. 13 del D. Lgv. 30 giugno 2003, n. 196