PT Otsuka Indonesia

PT Otsuka Indonesia is a pharmaceutical company operating in Indonesia, with its manufacturing site located in Lawang, Malang, East Java. As part of the global Otsuka Group, PT Otsuka Indonesia is committed to improving health and well-being through innovative pharmaceutical and healthcare solutions.

The Lawang, Malang site serves as a key production facility, manufacturing high-quality pharmaceutical products that meet international standards. The facility adheres to strict Good Manufacturing Practice (GMP) guidelines to ensure product safety and efficacy.

Our Project — e-QMS (Electronic Quality Management System)

We designed and built e-QMS — an Electronic Quality Management System for the Lawang factory — centered on a Learning Management System (LMS) with electronic signing, plus a suite of quality modules:

• Document authoring and revision — SOPs and quality documents with structured fields, attachments, version history, and controlled revisions.
• Controlled approval workflow — documents move through the approval hierarchy (QA review, section head, unit head, department head, QA manager) with role-based skipping and full progress logging.
• Electronic signatures (FDA 21 CFR Part 11) — each signer holds an X.509 certificate; signatures are cryptographically bound to the document, and the final PDF is digitally signed with P12 certificates. A public verification page allows signature validation.
• Training assignment and completion — documents are assigned to employees based on their roles, with completion tracking, deadlines, and quiz-based testing where required.
• Quality modules — CAPA, Change Control, Deviation, Complaint, Investigation, Risk Assessment, and Evaluation, each with its own controlled workflow, role separation, and audit trail.
• Tamper-proof audit logging — every action is recorded in a hash-chained audit log with integrity verification.

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