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 purchased 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.
Document lifecycle
Documentation Aligned with the Approved Machine Scope
The final document index should be agreed with the machine specification so drawings, manuals, certificates and qualification records match the manufactured configuration.
Design and Approval
User requirement review, approved technical offer, general arrangement drawing, process description, utility requirement and Design Qualification support where included.
Manufacturing Records
Applicable material certificates, purchased component information, electrical and pneumatic diagrams, inspection records and approved deviations according to the order.
Operation and Maintenance
Machine operating instructions, HMI guidance, cleaning and changeover information, preventive-maintenance tasks, troubleshooting notes and recommended spare-parts list.
Testing and Handover
Agreed Factory Acceptance Test records, calibration information where applicable, packing list, installation checks and Site Acceptance Test support when included.
Qualification clarity
What DQ, IQ, OQ and PQ Support Means
DQ — Design Qualification
DQ documents how the proposed machine design addresses the approved user requirement and technical specification before or during design approval.
IQ — Installation Qualification
IQ records installation details, identified components, utilities, manuals and drawings against the approved installation protocol.
OQ — Operational Qualification
OQ documents agreed functional tests, controls, alarms, interlocks and operating ranges using the approved protocol and test conditions.
PQ — Performance Qualification
PQ confirms performance in the user's process using approved product, packaging materials, methods and acceptance criteria. PQ is normally led and approved by the user; supplier evidence or execution support is defined separately.
Electronic Records and SCADA
Audit trails, access control, data retention, electronic signatures, backup and procedural controls must be specified and validated as a complete system. An HMI or SCADA component alone does not establish 21 CFR Part 11 compliance.
Change Control
Revisions after approval should be recorded so the final manuals, drawings and qualification documents represent the supplied machine.
Document availability, language, format, review cycle, acceptance criteria and execution responsibility must be written into the approved project scope. Examples on this page are not a promise that every document is included with every machine.
Need a Defined Documentation Package?
Send your URS or document list before quotation so the required scope can be reviewed.