Operating Information
Operation and maintenance manuals, safety information, recommended spares and preventive-maintenance guidance.
Project-specific document support
Pharmaceutical Machinery Quality Documentation
Documentation is prepared against the approved machine configuration, purchased scope, applicable standards and customer requirements.
Machine & Project Records
Approved Scope & TraceabilityDefined Before Order
Available by scope
Typical Machinery Document Package
The exact format, language, quantity and approval workflow are agreed before manufacture. Documents not included in the approved order are not supplied automatically.
Technical Drawings
Approved layout, utility requirements, electrical or pneumatic diagrams and relevant component information.
Inspection & Test Records
Agreed inspection reports, material or bought-out certificates, FAT records and calibration information where included.
Qualification support
DQ, IQ, OQ and PQ Support
Qualification-document support can be included where specified in the user requirement and commercial scope. Final protocols, responsibilities, acceptance criteria and site activities are agreed for each project.
01
Requirement Review
Confirm applicable standards, templates, language, review stages and approval responsibilities.
02
Document Planning
Define the document index, submission schedule and records required for the selected machine.
03
Factory Records
Compile agreed drawings, certificates, test results and approved deviations during manufacture.
04
Site Support
Provide installation or qualification assistance where included in the final project scope.
Need a Defined Documentation Package?
Send your URS or document list before quotation so the required scope can be reviewed.