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Installation Qualification/Operational Qualification

Protocols and Instructions

AquaLab 4TE, 4TEV

4TE DUO and 4TEV DUO

Decagon Devices, Inc  

 

June 28, 2016 11:24 AM 

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Summary of Contents for 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 1...

Page 2: ...testing System information Sensor Verification Equipment Familiarization Training Record Deficiencies and Corrective Actions Section 1 Section 2 Section 2 1 Section 2 2 Section 2 3 Section 2 4 Section...

Page 3: ...Final approval for the qualification has to be completed after review of the qualification documentation filled out during performance of the qualification procedures IQ OQ protocols The customer repr...

Page 4: ...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 pro...

Page 5: ...vity instrument The purchased AquaLab Water Activity instrument undergoing qualification is located at Company Name Department Address City State Country Zip code Postal Code Phone Number 2 1 Equipmen...

Page 6: ...Not Complete N A DUO Quick Start Guide Complete Not Complete N A DUO only Remarks N A All parts were received as ordered and the delivery is complete Yes No Any parts that were missing at the time of...

Page 7: ...n Satisfactory Not Satisfactory Accepted Other Satisfactory Not Satisfactory Accepted Remarks N A Qualified by Date Initials Severe damage to any of the delivered parts interrupts the installation qua...

Page 8: ...de doors or other items that may cause rapid temperature fluctuation Location Satisfactory Not Satisfactory Adequate Power Satisfactory Not Satisfactory Stable Surface Satisfactory Not Satisfactory Te...

Page 9: ...es Initial Qualification Requalification Decagon Devices Authorized Representative Name Function Company Date Signature Initials Installation Qualification was reviewed by the representative of the sy...

Page 10: ...ies 4 line of instruments contain a chilled mirror dewpoint sensor for determining water activity The 4TEV model contains both the chilled mirror sensor and a capacitance relative humidity sensor The...

Page 11: ...specification clean the instrument and follow the procedure in the User s Manual to perform a linear offset Repeat the verification process with fresh standards Dew Point Sensor Volatiles Sensor TEV o...

Page 12: ...Qualified by Date Initials Completeness of Operational Qualification OQ Operational Qualification was completed and documented according to manufacturers guidelines Initial Qualification Requalificat...

Page 13: ...agon Devices to learn about available training and seminars Authorized support specialists perform the qualification services offered by Decagon Devices Name Date Name Date Name Date Name Date Name Da...

Page 14: ...n Once accept able results are obtained the deficiency is accepted by checking the accepted box under the deficiency Deficiency Corrective Action Accepted Initial Deficiency Corrective Action Accepted...

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