Category | EasyMatch QC-ER

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Dec 19, 2025 by HunterLab

HunterLab’s EasyMatch QC-ER (Electronic Records) software is typically purchased by pharmaceutical companies to meet FDA 21 CFR Part 11 requirements for measuring the color of transparent and translucent liquids, translucent creams, powders, pressed plaques, round tablets, oval caplets and capsules as well as packaging materials.

With this software HunterLab supplies a Validation and Compliance Notebook that implements IQOQPQ protocols as follows:

IQ – Installation Qualification

IQ – Installation Qualification defines a protocol by which a HunterLab instrument is set up and turned on; software is installed on a PC as needed and both hardware and software elements verified to be working correctly together by completing a successful instrument standardization.

Following the Validation and Compliance Notebook, IQ consists of the following three elements:

Procedure 1 – Installation of Hardware for all sensors sensor to the point such that the instrument is powered up and ready. Connect the sensor communication cable to the PC.
Procedure 2 – Installation of EZMQC-ER Software for All Systems.
EasyMatch QC-ER is successfully opened and the sensor loaded. When the sensor beeps or responds, power and communications between software and sensor have been established. Proceed to standardize the instrument. When successful, IQ Installation Qualification has been achieved.

OQ – Operation Qualification

OQ – Operation Qualification defines a protocol in which the sensor diagnostics tests are run and verified to PASS indicating that the instrument is operating correctly to manufacturer’s tolerances.

Procedure 3 – Checking Wavelength Accuracy verification on the Didymium Filter for sphere instruments only.
Procedure 4 – Checking Short Term Repeatability on a White Tile for all sensors.
Procedure 5 – Checking Mid-Range Performance or Long Term Repeatability on the Green Tile for all sensors.

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Apr 20, 2023 by HunterLab

El software EasyMatch QC-ER (Registros Electrónicos) de HunterLab suele ser adquirido por empresas farmacéuticas para cumplir los requisitos de la FDA 21 CFR Parte 11 para la medición del color de líquidos transparentes y translúcidos, cremas translúcidas, polvos, placas prensadas, comprimidos redondos, cápsulas ovaladas y cápsulas, así como materiales de envasado.

Con este software HunterLab suministra un Cuaderno de Validación y Cumplimiento que implementa los protocolos IQOQPQ de la siguiente manera:

IQ - Cualificación de la instalación

IQ - Installation Qualification define un protocolo por el cual un instrumento HunterLab se configura y se enciende; el software se instala en un PC según sea necesario y se verifica que tanto los elementos de hardware como de software funcionan correctamente juntos completando una estandarización exitosa del instrumento.

Tras el Cuaderno de Validación y Cumplimiento, el CI consta de los tres elementos siguientes:

Procedimiento 1 - Instalación del Hardware para todos los sensores sensor hasta el punto tal que el instrumento esté encendido y listo. Conecte el cable de comunicación del sensor al PC.
Procedimiento 2 - Instalación del software EZMQC-ER para todos los sistemas.
EasyMatch QC-ER se ha abierto correctamente y se ha cargado el sensor. Cuando el sensor emite un pitido o responde, se han establecido la alimentación y las comunicaciones entre el software y el sensor. Proceda a normalizar el instrumento. Si se ha realizado correctamente, se ha obtenido la Cualificación de Instalación IQ.

OQ - Cualificación de la operación

OQ - Operation Qualification define un protocolo en el que se ejecutan las pruebas de diagnóstico del sensor y se verifica que PASA, lo que indica que el instrumento funciona correctamente según las tolerancias del fabricante.

Procedimiento 3 - Comprobación de la precisión de la longitud de onda verificación en el Filtro Didimio sólo para instrumentos de esfera.
Procedimiento 4 - Comprobación de la Repetibilidad a Corto Plazo en una Baldosa Blanca para todos los sensores.
Procedimiento 5 - Comprobación del Rendimiento de Rango Medio o Repetibilidad a Largo Plazo en la Baldosa Verde para todos los sensores.

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Apr 20, 2023 by HunterLab

HunterLabのEasyMatch QC-ER（電子記録）ソフトウェアは、通常、製薬会社が透明および半透明の液体、半透明のクリーム、粉末、圧搾プラーク、丸い錠剤、楕円形のカプレットおよびカプセル、ならびに包装材料の色を測定するためのFDA 21 CFR Part 11要件を満たすために購入されます。

HunterLabは、このソフトウェアとともに、以下のIQOQPQプロトコルを実装したバリデーションおよびコンプライアンスノートブックを提供します：

IQ - 設置資格

IQ - Installation Qualification は、HunterLab装置がセットアップされ、電源が入れられ、必要に応じてソフトウェアがPCにインストールされ、装置の標準化が完了することでハードウェアとソフトウェアの両方が正しく動作することが確認されるプロトコルを定義しています。

バリデーション＆コンプライアンス・ノートブックに続き、IQは以下の3つの要素で構成される：

Procedure 1 - Installation of Hardware すべてのセンサーについて、センサーの電源が入り、準備が整ったところまでセンサーを設置します。センサーの通信ケーブルをPCに接続します。
手順2 - EZMQC-ERソフトウェアの全システムへのインストール.
EasyMatch QC-ER が正常に開かれ、センサーがロードされます。センサーがビープ音を鳴らすか反応したら、ソフトウェアとセンサー間の電源と通信が確立されたことになります。装置の標準化に進みます。成功すると、IQ設置認定が達成されます。

OQ - オペレーション・クオリフィケーション

OQ - Operation Qualification は、センサー診断テストを実行し、機器が製造元の許容範囲内で正しく動作していることを示すPASSを検証するプロトコルを定義しています。

Procedure 3 - Checking Wavelength Accuracy ディディミウム・フィルターの検証（球面測定器のみ）。
手順4 - すべてのセンサーの白タイルで短期反復性をチェックする。
手順5 - すべてのセンサーの緑色のタイルで中間域の性能または長期繰返し精度をチェックする。

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Apr 20, 2023 by HunterLab

HunterLab’s EasyMatch QC-ER (Electronic Records) software is typically purchased by pharmaceutical companies to meet FDA 21 CFR Part 11 requirements for measuring the color of transparent and translucent liquids, translucent creams, powders, pressed plaques, round tablets, oval caplets and capsules as well as packaging materials.

With this software HunterLab supplies a Validation and Compliance Notebook that implements IQOQPQ protocols as follows:

IQ – Installation Qualification

IQ – Installation Qualification defines a protocol by which a HunterLab instrument is set up and turned on; software is installed on a PC as needed and both hardware and software elements verified to be working correctly together by completing a successful instrument standardization.

Following the Validation and Compliance Notebook, IQ consists of the following three elements:

Procedure 1 – Installation of Hardware for all sensors sensor to the point such that the instrument is powered up and ready. Connect the sensor communication cable to the PC.
Procedure 2 – Installation of EZMQC-ER Software for All Systems.
EasyMatch QC-ER is successfully opened and the sensor loaded. When the sensor beeps or responds, power and communications between software and sensor have been established. Proceed to standardize the instrument. When successful, IQ Installation Qualification has been achieved.

OQ – Operation Qualification

OQ – Operation Qualification defines a protocol in which the sensor diagnostics tests are run and verified to PASS indicating that the instrument is operating correctly to manufacturer’s tolerances.

Procedure 3 – Checking Wavelength Accuracy verification on the Didymium Filter for sphere instruments only.
Procedure 4 – Checking Short Term Repeatability on a White Tile for all sensors.
Procedure 5 – Checking Mid-Range Performance or Long Term Repeatability on the Green Tile for all sensors.

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Apr 20, 2023 by HunterLab

HunterLab’s EasyMatch QC-ER (Electronic Records) software is typically purchased by pharmaceutical companies to meet FDA 21 CFR Part 11 requirements for measuring the color of transparent and translucent liquids, translucent creams, powders, pressed plaques, round tablets, oval caplets and capsules as well as packaging materials.

With this software HunterLab supplies a Validation and Compliance Notebook that implements IQOQPQ protocols as follows:

IQ – Installation Qualification

IQ – Installation Qualification defines a protocol by which a HunterLab instrument is set up and turned on; software is installed on a PC as needed and both hardware and software elements verified to be working correctly together by completing a successful instrument standardization.

Following the Validation and Compliance Notebook, IQ consists of the following three elements:

Procedure 1 – Installation of Hardware for all sensors sensor to the point such that the instrument is powered up and ready. Connect the sensor communication cable to the PC.
Procedure 2 – Installation of EZMQC-ER Software for All Systems.
EasyMatch QC-ER is successfully opened and the sensor loaded. When the sensor beeps or responds, power and communications between software and sensor have been established. Proceed to standardize the instrument. When successful, IQ Installation Qualification has been achieved.

OQ – Operation Qualification

OQ – Operation Qualification defines a protocol in which the sensor diagnostics tests are run and verified to PASS indicating that the instrument is operating correctly to manufacturer’s tolerances.

Procedure 3 – Checking Wavelength Accuracy verification on the Didymium Filter for sphere instruments only.
Procedure 4 – Checking Short Term Repeatability on a White Tile for all sensors.
Procedure 5 – Checking Mid-Range Performance or Long Term Repeatability on the Green Tile for all sensors.

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

Posted on Apr 20, 2023 by HunterLab

Die EasyMatch QC-ER (Electronic Records) Software von HunterLab wird in der Regel von pharmazeutischen Unternehmen gekauft, um die Anforderungen der FDA 21 CFR Part 11 für die Messung der Farbe von transparenten und transluzenten Flüssigkeiten, transluzenten Cremes, Pulvern, gepressten Platten, runden Tabletten, ovalen Kapseln und Kapseln sowie Verpackungsmaterialien zu erfüllen.

Mit dieser Software liefert HunterLab ein Validierungs- und Konformitätsbuch, das die IQOQPQ-Protokolle wie folgt implementiert:

IQ - Installationsqualifizierung

IQ - Installation Qualification definiert ein Protokoll, mit dem ein HunterLab-Gerät eingerichtet und eingeschaltet wird; die Software wird bei Bedarf auf einem PC installiert, und sowohl die Hardware- als auch die Softwareelemente werden durch eine erfolgreiche Standardisierung des Geräts auf ihre korrekte Funktionsweise überprüft.

Im Anschluss an das Validierungs- und Konformitätsnotizbuch besteht IQ aus den folgenden drei Elementen:

Vorgehensweise 1 - Installation der Hardware für alle Sensoren Sensor bis zu dem Punkt, dass das Gerät eingeschaltet und bereit ist. Schließen Sie das Kommunikationskabel des Sensors an den PC an.
Vorgehensweise 2 - Installation der EZMQC-ER-Software für alle Systeme.
EasyMatch QC-ER wurde erfolgreich geöffnet und der Sensor geladen. Wenn der Sensor piept oder antwortet, wurden die Stromversorgung und die Kommunikation zwischen Software und Sensor hergestellt. Fahren Sie mit der Standardisierung des Geräts fort. Wenn dies erfolgreich war, wurde die IQ-Installationsqualifizierung erreicht.

OQ - Qualifizierung für den Betrieb

OQ - Operation Qualification definiert ein Protokoll, in dem die Sensordiagnosetests durchgeführt und mit PASS verifiziert werden, was bedeutet, dass das Gerät innerhalb der Herstellertoleranzen korrekt arbeitet.

Vorgehensweise 3 - Überprüfung der Wellenlängengenauigkeit Überprüfung des Didymiumfilters nur für Kugelinstrumente.
Vorgang 4 - Überprüfung der kurzfristigen Wiederholbarkeit auf einer weißen Kachel für alle Sensoren.
Vorgang 5 - Überprüfung der mittleren Leistung oder der langfristigen Wiederholbarkeit auf der grünen Kachel für alle Sensoren.

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"How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?"

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"How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?"

"How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?"

"How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?"

"How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?"

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ – Installation Qualification

OQ – Operation Qualification

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ - Cualificación de la instalación

OQ - Cualificación de la operación

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ - 設置資格

OQ - オペレーション・クオリフィケーション

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ – Installation Qualification

OQ – Operation Qualification

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ – Installation Qualification

OQ – Operation Qualification

How do I perform an DQ IQ OQ PQ RQ using EasyMatch QC-ER?

IQ - Installationsqualifizierung

OQ - Qualifizierung für den Betrieb