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Table of Contents
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Summary of Contents for Decagon Devices AquaLab 4TE
- Page 1 Installation Qualification/Operational Qualification Protocols and Instructions AquaLab 4TE, 4TEV 4TE DUO and 4TEV DUO Decagon Devices, Inc June 28, 2016 11:24 AM...
- Page 2 Section 3.2 System information Pg. 10 Section 3.2.1 Sensor Verification Pg. 10 Section 3.2.2 Equipment Familiarization Pg. 12 Appendix 1 Training Record Pg. 13 Appendix 2 Deficiencies and Corrective Actions Pg. 14 Decagon Devices, Inc June 28, 2016 11:24 AM...
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Page 3: Section 1 - Introduction
The instrument qualification carried out onsite is the sole responsibility of the instrument owner/user. However, Decagon Devices supports their customers in performing the qualification by providing the instrument qualification dedicated documentation and offering a qualification service. In this regard, the... - Page 4 All equipment users are to be instructed in basic operation, functionality, instrument parameters, as well as on basic hardware features of the installed system including routine maintenance and cleaning proce- dures. Please contact Decagon Devices to learn about available training and seminars. Authorized support specialists perform the qualification services offered by Decagon Devices.
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Page 5: Section 2 - Installation Qualification (Iq)
4TEV 4TE DUO 4TEV DUO Manufacturer: DECAGON DEVICES Model Number: Serial Number: Decagon Devices Authorized Representative Name: Date: Signature: Initials: 2.2 Receiving and Unpacking Verify that the external packaging was not damaged during shipment in a way that the internal package content might be damaged. - Page 6 IQ/OQ process. Completed can be marked once the item has been received. Date Initials Item: Accepted Completed Accepted Completed Accepted Completed Decagon Devices, Inc June 28, 2016 11:24 AM...
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Page 7: Visual Inspection
Severe damage to any of the delivered parts interrupts the installation qualification until the part is re- placed. Completion of the installation qualification after replacement is documented below. AquaLab Instrument Satisfactory Not Satisfactory Documentation Satisfactory Not Satisfactory Other Satisfactory Not Satisfactory Decagon Devices, Inc June 28, 2016 11:24 AM... -
Page 8: Environmental Conditions
After finding a good location for the AquaLab Water Activity meter, plug the power cord into the back of the unit and a standard AC outlet. The ON/OFF switch is located in the lower left corner of the back panel. Instrument is powered upon switching on Remarks: Decagon Devices, Inc June 28, 2016 11:24 AM... - Page 9 Completeness of Installation Qualification (IQ) Installation Qualification was completed and documented according to manufacturer’s guidelines. Initial Qualification Requalification Decagon Devices Authorized Representative Name: Function: Company: Date: Signature: Initials: Installation Qualification was reviewed by the representative of the system owner. Reviewed and approved by:...
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Page 10: Section 3 - Operational Qualification (Oq)
+/- 0.003 aw of the stated value. The capacitance (volatiles) sensor will read each standard within +/- 0.015 aw of the stated value. To measure the water activity of the standards, follow the instructions in the User’s Manual for taking a reading. Decagon Devices, Inc June 28, 2016 11:24 AM... - Page 11 ±0.003 °C ±0.015 °C 13.41m LiCl 0.250 0.250 8.57m LiCl 0.500 0.500 6.0m NaCl 0.760 0.760 1.00 Steam Distilled H 1.00 Water Activity Verification Standards Within Specification Remarks: Qualified by: Date: Initials: Decagon Devices, Inc June 28, 2016 11:24 AM...
- Page 12 Operational Qualification was completed and documented according to manufacturers guidelines. Initial Qualification Requalification Qualifications met Vendor Acceptance Criteria If any deficiencies are found, fill out the instructions for a corrective action on Pg. 14 of this document. Decagon Devices Authorized Representative Name: Function: Company: Date:...
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Page 13: Training Record
This training record is for instruction in basic operation, functionality, instrument parameters, as well as on basic hardware features of the installed system including routine maintenance and cleaning procedures. Please contact Decagon Devices to learn about available training and seminars. Authorized support specialists perform the qualification services offered by Decagon Devices. - Page 14 “accepted” box under the deficiency. Deficiency: Corrective Action: Accepted Initial Deficiency: Corrective Action: Accepted Initial Decagon Devices Authorized Representative Name: Function: Company: Date: Signature: Initials: Decagon Devices, Inc June 28, 2016 11:24 AM...
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