Design QualificationReview of proposed machine design against intended application, technical specification and customer User Requirement Specification.
Resources
Validation Service
Validation documentation support for regulated packaging machinery projects.
Validation Services
Validation documentation prepared around approved machine design and customer URS.
Technogen supports regulated machinery projects with structured qualification and documentation records. The exact scope depends on the confirmed machine configuration, automation level, URS and order requirement.
Installation QualificationVerification support for installed machine, components, utilities, manuals, drawings and approved installation references.
Operational QualificationOperating sequence, alarms, interlocks, HMI functions, speed range and machine-function checks within approved operating limits.
Functional Design SpecificationPLC, HMI, sensors, drives, alarms, interlocks, access levels, recipes and control philosophy documentation where applicable.
Factory Acceptance TestFactory-level verification of workmanship, construction, controls, safety functions and sample trials where applicable.
Site Acceptance TestSite-level verification after installation, utility connection, line integration and operator support where included in the scope.
Material CertificatesMaterial of Construction certificate support for applicable stainless-steel, product-contact and bought-out components.
21 CFR Part 11 OptionsCompliance-related automation and documentation options can be discussed where specified; compliance depends on approved project scope.
Validation Services FAQ
Common buyer questions.
Which validation documents can be discussed?
DQ, IQ, OQ, FDS, FAT, SAT, manuals, material certificates and project-specific documentation can be discussed depending on the machine and confirmed order scope.
Is every machine automatically 21 CFR Part 11 compliant?
No. 21 CFR Part 11-related functions and documents must be specified and approved in the project scope before manufacturing.
What should customers provide?
Customers should share URS, product and pack information, process sequence, cleaning expectation, utility details, acceptance criteria and any internal documentation format.