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Best in the industry
Provides detailed testing reports on all IQ/OQ validation procedures, as well as, all component manuals, test certificates and documentation.

Well-organized and comprehensive
It is designed to meet FDA recommended protocols and requirements and reduce your validation timeline from months to days.

Base IQ/OQ Documentation Packages
These IQ/OQ turnover packages can include, but are not limited to, the following:

• Full system component list with mfg, connections sizes, component model #'s and serial #'s.
• All component certifications, including certificates of compliance and calibration certificates, where appropriate.
• Material heat sheets, certs for fittings and tubing
• System Piping & Instrumentation diagram
• General Arrangement drawings
• Electrical Binder including:
  • Complete wiring schematics
  • Control panel layout drawings
  • Electrical bill of material
  • Electrical component manuals and cut sheets.
  • UL certificate for control panel
• Components Binder including:
  • All component manuals and cut sheets
  • Component List
• User's manual including software operational descriptions
• Maintenance guide, including list of recommended spare parts with typical consumption rates and preventive maintenance schedule.

Pre-Delivery IQ/OQ Validation and Documentation Package
This industry-leading, comprehensive IQ/OQ validation documentation package can be provided in addition to the base IQ/OQ documentation package. It can include the following:

• 3D eDrawing of skid systemprovides full 360º rotational view of skid & zooming ability.
• Component and Instrument Data Sheets submitted to user for review and approvals
• Software manual, including procedures/protocols for the following:
  • Software backup and restore
  • Disaster recovery
• Certificate of 21CFR Part 11 capability
• Installation plan
• Spare Parts List
• TÜV certificate as appropriate
• CE Declaration of Conformity if required
• Compliance with the EC EMC, LVD, PED, ATEX directives as appropriate
• Electrical and pneumatic bills of material
• Utilities datasheet (consumption of electrical and pneumatic)
• Frame and Piping Binder including:
  • weld logs for all product contact pipework individual drawings for all custom fabricated pipework
  • weld maps
  • surface finish reports for fabricated tubing and heat
  • exchanger coil
  • passivation report
  • videotape of boroscopic inspection (where possible)
• Asahi Kasei Bioprocess Acceptance Testing protocols, execution and documentation including:
  • Field Component Acceptance documents and sign-offs, including documentation of thorough QC checks of all system field components.
  • Field Components Installation documents and sign-offs, including documentation of thorough installation checks of all system field components.
  • Field Component Operational documents and sign-offs, including documentation of thorough operational checks of all system field components.
  • Electrical Component verification documents and sign-offs, including documentation of thorough checks of all electrical components.
  • Software function verification documents and sign offs.
  • As many as 200 (depending on final system specs) signed-off software criteria forms, each detailing the results of an individual software test that is defined by Asahi Kasei Bioprocess
  • Standard Operating Procedures.
  • System Alarm documents and sign offs, including documentation of the verification of proper alarm functionality.
  • FAT protocol
  • FAT report
• Commissioning and Validation Support