[blogcard url=”” title=”【ISO-13485:2016対応】マネジメントレビュ規程・手順書・様式” content=”QSR(品質システム規則)査察では、経営者(マネージメント)の責任が強く問われます。”]

[blogcard url=”” title=”【ISO-13485:2016対応】CAPA規程・手順書・様式” content=”ISO-13485:2016に沿った形のCAPAに関する規程・手順書・様式集です。

[blogcard url=”” title=”【ISO-13485:2016対応】苦情処理規程・手順書・様式” content=”ISO-13485:2016に沿った形の苦情処理に関する規程・手順書・様式集です。

[blogcard url=”” title=”【ISO-13485:2016対応】不適合品管理規程・手順書・様式” content=”ISO-13485:2016に沿った形の不適合品管理に関する規程・手順書・様式集です。 FDAが要求する不適合品管理は、CAPAと密接に関連し、またFDAへの報告の要否を判断しなければなりません。”]

[blogcard url=”” title=”【ISO-13485:2016対応】内部監査規程・手順書・様式” content=”ISO-13485:2016に沿った形の内部監査に関する規程・手順書・様式集です。
FDAは、4半期に一度の内部監査を求めています。 内部監査を実施するために必要な手順書、様式を整備しておかなければなりません。”]

[blogcard url=”” title=”【FDA CFR 820 QSR対応】マネージメントレビュ規程・手順書・様式” content=”QSR(品質システム規則)査察では、経営者(マネージメント)の責任が強く問われます。”]

[blogcard url=”” title=”【FDA CFR 820 QSR対応】CAPA規程・手順書・様式” content=”FDA QSRに沿った形のCAPAに関する規程・手順書・様式集です。

[blogcard url=”” title=”【FDA CFR 820 QSR対応】苦情管理規程・手順書・様式” content=”FDA QSRに沿った形の苦情管理に関する規程・手順書・様式集です。

[blogcard url=”” title=”【FDA CFR 820 QSR対応】不適合品管理規程・手順書・様式” content=”FDA QSRに沿った形の不適合品管理に関する規程・手順書・様式集です。 FDAが要求する不適合品管理は、CAPAと密接に関連し、またFDAへの報告の要否を判断しなければなりません。”]

[blogcard url=”” title=”【FDA CFR 820 QSR対応】内部監査規程・手順書・様式” content=”FDA QSRに沿った形の内部監査に関する規程・手順書・様式集です。
FDAは、4半期に一度の内部監査を求めています。 内部監査を実施するために必要な手順書、様式を整備しておかなければなりません。”]

[blogcard url= title=”QMS(手順書)ひな形 医薬品関連” ]

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