保管倉庫および物流拠点向けのヴァイサラのソリューションが、適正流通規範（GDP）遵守エリアでの規制違反や製品損失のリスクを低減します。
ヴァイサラの viewLinc継続モニタリングシステムは以下を提供します。
- 有線、PoE、Wi-Fi または ヴァイサラ独自の無線技術 VaiNetを用いた容易な接続による低い所有コスト
- Good Distribution Practiceへのコンプライアンスに関する欠損のない保護されたデータ記録
- SMS、Eメール、またはローカルアラートを介した年中無休のリモート アラーム
- 要求に応じて自動作成されEメールで配信されるユーザー設定によるレポート
- 通信量の多い保管倉庫環境およびアクセスしにくい棚向けの無線センサオプション
- 円滑な起動のための、迅速で簡単な据付時適格性評価（IQ）/運転時適格性評価（OQ）バリデーション文書または現場設置／検証サービス
- スポットチェックや変換器の現場校正向けにハンディタイプの温度湿度計も提供しています。
- 頑丈で高精度なデータロガーにより、同じ装置で マッピング/検証研究 が可能
データロガーは非常に安定しており、検証/マッピング研究に適しています。 ヴァイサラのマッピングキットを使用すると、保管場所を認定する時間とコストを節約できます。
倉庫検証 & 検証マスタープラン
検証マスタープランは、お客様の検証作業をオーガナイズし、施設の品質目標をサポートする方法を理解することに役立ちます。マスタープランは監査員にも喜ばれます。VMPの監査準備が整っていることを確実にするため、12のチェックポイントについて 「Validation Master Plan」のブログポスト 、ならびにFDAガイダンス、ICH品質ガイドライン、EMAドラフトガイドライン、および付録15の要件のリンクをお読みください。
倉庫モニタリング & 検証の詳細
保管倉庫に対する適正保管出荷基準
薬剤、生物製剤、医療機器の保存用または保管用のエリアには、適正保管出荷基準では、製品の純度・品質・安全性に影響を及ぼす恐れがある温度や湿度などの変数を制御する環境管理システムが求められます。
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GxP基準規則の条項
記事、ホワイトペーパー、アプリケーションノート、Eブックなどを収めた当社の所蔵庫をご覧ください。