Makeen Document Control System: Development, Standards-Based Validation, and Early Multisite Implementation of a Saudi-Built Laboratory Document Control Platform.

内容摘要

Background Document control is a core requirement of laboratory quality management and accreditation, including under the College of American Pathologists (CAP), International Organization for Standardization (ISO) 17025, ISO 15189, the Association for the Advancement of Blood & Biotherapies (AABB), and the Central Board for Accreditation of Healthcare Institutions (CBAHI). Before 2024, many Saudi laboratories relied on paper-based systems or imported platforms that lacked Arabic-language functionality, local hosting, and explicit alignment with Saudi regulatory and governance requirements. Objective To describe the development, standards-based internal validation, and early multisite implementation of the Makeen Document Control System (Makeen DCS), a Saudi-built laboratory document control platform designed for accreditation-oriented use in Saudi Arabia, and to assess early feasibility and user-perceived acceptability rather than comparative effectiveness. Methods This descriptive implementation and feasibility study was conducted from October 2024 to January 2026. System requirements were derived from CAP, ISO 17025, ISO 15189:2022, AABB, CBAHI, FDA 21 CFR Part 11, and Saudi Personal Data Protection Law (PDPL) requirements and translated into software specifications. Development followed staged requirements definition, prototyping, workflow refinement, internal validation, and pilot deployment. Internal validation used 126 structured test cases across user access, document creation and upload, approval workflow, version control, retrieval, audit trail behavior, and administrative functions. Early implementation was undertaken in seven purposively selected pioneer laboratory sites. User feedback was collected through an internally developed implementation survey completed by eight participants from pilot sites. Results The Makeen DCS provided end-to-end document lifecycle management, role-based access control, bilingual Arabic-English interfaces, dynamic master document lists, searchable retrieval, audit-oriented reporting, and a personnel-documentation module. The system supported both Saudi-hosted cloud deployment and on-premises implementation. Functional alignment was mapped against selected CAP, ISO 17025, ISO 15189:2022, CBAHI, AABB, FDA Part 11, and PDPL requirements. Among 126 validation test cases, 109/126 (86.5%) passed on first execution, and 17/126 (13.5%) failed initially; all failed items were corrected and retested, resulting in a final pass rate of 100% (126/126). Early deployment was achieved across seven diverse sites, of which six were fully active, and one remained partially implemented by study cut-off. Median active users across sites were 80 (range: 30-200), median configured departments were 10 (range: 5-15), and median migrated or newly created controlled documents were 76 (range: 10-274) across six sites with available data. User feedback was favorable, with a mean satisfaction score of 9/10, 7/8 (87.5%) respondents willing to recommend the platform, and 8/8 (100.0%) perceiving improved inspection readiness and reduced manual or paper-based workload. Conclusions Makeen DCS was feasible as a Saudi-built/bilingual/locally hosted lab platform for accreditation workflows. Internal validation, pilot use, and small-sample feedback show readiness/acceptability, not operational effectiveness; independent longitudinal evaluation is needed.