Chemical – Pharmaceutical
AUTECO – Software for Industrial Automation
Management of: WFI loop, PWS loop, treatment, powder and liquid dosing, mixing, CIP, packaging lines, palletizing, purification (suppositories, tablets, pills).
Technical Support
Development of the necessary documentation for process validation according to protocols and validation plans (DQ, IQ, OQ).
Quality plan/Functional Specifications/Hardware Project Specification/Software Project Specification/Factory Acceptance Test/Site Acceptance Test/Installation Qualification/Operational Qualification.
Supply of control systems for new plants and for the revamping of existing plants:
- DOSING/STERILIZATION/TREATMENT/SANITIZATION;
- WATER DISTRIBUTION/SOFTENERS/FILTERS.
21 CFR: PART 11 – DATA SECURITY
User access management with security criteria in compliance with “21 CFR: PART 11” – Food and Drug Administration.
Documentation for validation:
Quality plan
Functional specifications
Hardware project specification
Software project specification
Factory Acceptance Test
Site Acceptance Test
Installation Qualification
Operational Qualification
Do you need information?
Get in touch with our team.