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Artikel Review: Parameter dalam pembuatan Standar Operasional Prosedur (SOP) evaluasi penerapan Computer System Validation (CSV)
Abstrak
Industri farmasi diwajibkan untuk mematuhi pedoman Cara Pembuatan Obat yang Baik (CPOB) sebagai upaya menjamin mutu, keamanan, dan efektivitas produk, termasuk dalam pengelolaan sistem komputerisasi melalui penerapan Computerized System Validation (CSV). Kajian berkala terhadap sistem CSV dilakukan untuk memastikan bahwa sistem komputerisasi tetap berada dalam kondisi tervalidasi, beroperasi sesuai dengan tujuan penggunaannya, serta memenuhi ketentuan regulatori yang berlaku, seperti CPOB 2024, GMP Annex 11, USP <1058>, dan ISO/IEC 27001. Penelaahan mencakup aspek pengendalian perubahan (change control), penanganan penyimpangan (deviation review), tinjauan keamanan dan pengelolaan akses sistem, evaluasi audit trail, verifikasi mekanisme backup–restore, serta pemantauan kinerja dan keandalan sistem secara berkelanjutan. Hasil kajian menunjukkan tidak ditemukannya indikasi penyimpangan operasional, penurunan performa sistem, maupun risiko terhadap integritas dan keamanan data. Seluruh aktivitas pengelolaan perubahan dan pemeliharaan sistem dilaksanakan secara terencana, terdokumentasi, dan tervalidasi dengan baik, termasuk penerapan Disaster Recovery Plan (DRP) yang mendukung kesinambungan operasional. Selain itu, sistem komputerisasi telah memenuhi prinsip ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, dan Available), sehingga menjamin akurasi, keterlacakan, serta perlindungan data dari akses yang tidak sah. Secara keseluruhan, kajian ini menunjukkan bahwa sistem komputerisasi di industri farmasi dapat beroperasi secara andal dan stabil serta selaras dengan persyaratan CPOB, GMP, dan ISO/IEC 27001 dalam mendukung kegiatan produksi dan pengawasan mutu.
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