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    生命科学领域的数字化 – 利用合规的数字解决方案实现运营现代化与精简

    生命科学领域的数字化

    利用合规的数字解决方案实现运营现代化与精简

    QbD Group 帮助 Life Sciences 企业实现运营现代化与精简。我们量身定制的数字化解决方案确保平稳过渡到更高效、更敏捷且更合规的流程，同时保障数据完整性与长期增长。

    生命科学领域的数字化是指什么？

    数字化是将信息和流程从模拟格式转换为数字格式的过程。通过利用尖端技术，我们将手工和纸质工作流程转变为合规、自动化且数据驱动的系统。

    这一转变帮助组织提升效率、确保可追溯性并推动创新，同时加强法规合规和客户体验。我们在软件实施、验证和 IT 合作方面的专业知识，架起了法规要求、业务流程与技术之间的桥梁。

    生命科学领域的数字化 — Software Solutions & Services — QbD Group

    WHERE YOU ARE TODAY

    Where you are today

    Digitalisation is not one project. It is three stages, and the order matters. The fourth stage, AI, only works once these are done.

    Standardise

    Foundation

    Consistent, repeatable, compliant processes.

    You are here if

    • The same compliance gaps recur
    • Shifts reconcile data by hand
    • Audit observations repeat year after year
    • Knowledge sits with individuals instead of in the process

    What we do

    • SOP development and workflow optimisation
    • GxP gap assessment and remediation
    • Computer system validation fundamentals
    • ALCOA+ implementation and data integrity programmes

    We get you audit-ready and prepared for digitalisation.

    Digitalise

    Enablement

    Digitally enable the processes you have standardised.

    You are here if

    • Paper and Excel still do real work
    • You are selecting or replacing a core system
    • Validation happens at the end instead of by design

    What we do

    • System selection for regulated environments
    • Validation excellence covering CSV, URS, DQ, IQ, OQ, PQ and 21 CFR Part 11
    • Regulatory alignment on Annex 11, data integrity and inspection readiness
    • Change management covering adoption, training and SOP updates

    We do not just implement systems. We validate them for compliance.

    Automate

    Integration

    Connect validated systems so processes run end to end without manual handoffs.

    You are here if

    • Core systems are validated but people still move data between them
    • Reporting is assembled by hand from several sources
    • The same information is entered twice
    • Instrument, plant and IT data live in separate worlds

    What we do

    • System and data integration across ERP, MES, QMS and LIMS
    • Workflow automation across departments
    • IT and OT convergence
    • Master data governance
    • Validation of interfaces and automated workflows
    • Cloud and infrastructure qualification

    We remove the manual steps between your systems, and we validate the automation.

    BeforeAfter working with QbD Group
    Paper batch recordsElectronic batch records
    Manual data entryAutomated data capture
    Siloed spreadsheetsIntegrated QMS and LIMS
    Manual handoffs between teamsEnd-to-end automated workflows
    Reactive reportingReal-time dashboards
    Validation as an afterthoughtValidation by design
    Steering the plant manuallyDigital twin

    数字化为何对您重要

    提升效率

    流程精简和减少人工工作可带来显著的成本节约和生产力提升。

    改善决策

    简化的数据管理和增强的可访问性支持基于数据的明智决策。

    增强敏捷性

    数字化系统使组织更容易适应市场变化和不断演变的客户需求。

    数字化为何重要 — QbD Group

    数字化的优势

    数字化为您的运营带来可衡量的改进，从效率和创新到竞争优势。

    精简运营

    减少人工流程、降低错误并提高效率。

    增强数据利用

    简化数据管理并提升可访问性，助力更智慧的决策。

    创新驱动

    通过先进的数字技术推动新解决方案和业务模式的发展。

    提升竞争力

    快速响应市场变化、满足客户期望并保持领先地位。

    从评估到落地

    在 QbD Group，我们引导您完成数字化转型的每个阶段，确保量身定制并无缝融入您的运营：

    需求评估

    我们分析您当前的运营，识别数字化可以带来可衡量改进的领域。

    供应商与产品选型

    我们帮助您选择适合特定需求的数字解决方案。凭借技术中立的方法和深入的市场知识，我们比较广泛的解决方案 —— 从简单工具到复杂的企业平台。这一步往往至关重要且充满挑战。选错系统可能代价高昂；我们的专家确保您的投资在价值、功能和合规方面都能获得回报。

    方案设计

    我们根据您的需求和长期目标设计量身定制的数字化方案。

    软件实施

    我们实施一流的软件解决方案，实现任务自动化并优化工作流程。

    验证与合规

    我们依据 Annex 11、21 CFR Part 11 和 GAMP5 标准对每个系统进行验证，以保障数据完整性和法规合规。

    变更管理

    我们提供培训、文档和用户支持，确保团队能够顺利接纳新系统。

    AI enablement

    Where automation opens the door to AI, we hand over to a governed adoption programme rather than leaving the risk with you.

    数字化流程 — Software Solutions & Services — QbD Group

    WHERE WE TYPICALLY START

    Where we typically start

    Nobody wakes up wanting a maturity model. They wake up with a migration deadline or a lab that will not reconcile. These are the situations we see most often.

    DIGITALISE AND AUTOMATE

    SAP upgrade or migration

    The trigger: An S/4HANA migration, a major version upgrade, or a move to cloud ERP with GxP scope.

    What we do

    • Validation strategy and execution alongside the migration, not after it
    • Data migration verification with inspection-ready evidence
    • Interface qualification across the connected systems
    • Change management, training and SOP updates

    Top-20 CDMO, S/4HANA migration across four GxP sites. Validation delivered inside the migration timeline, eleven weeks end to end, zero critical findings at the following inspection.

    DIGITALISE AND AUTOMATE

    Laboratory software and system integration

    The trigger: A LIMS selection or replacement, instrument integration, or a lab still running spreadsheets alongside a validated LIMS.

    What we do

    • LIMS and ELN selection and implementation
    • Instrument interfacing and chromatography data system integration
    • Data integrity assessment and remediation
    • Validation of the systems and the interfaces between them

    Mid-size biotech, LIMS replacement with twelve instrument interfaces. Manual transcription removed from QC release, sample turnaround down by a third.

    STANDARDISE THROUGH AUTOMATE

    IT infrastructure and cloud

    The trigger: A cloud migration, a data centre exit, or infrastructure that has never been formally qualified.

    What we do

    • IT infrastructure qualification
    • Cloud supplier assessment and shared responsibility mapping
    • Periodic review and operational software compliance
    • Data integrity monitoring across the hosted environment

    European pharma manufacturer, data centre exit to cloud. Infrastructure qualified and shared responsibility documented ahead of the next regulatory inspection.

    SYSTEMS REFERENCE

    The systems we work with

    Production and manufacturing operations

    Production planning and schedulingManufacturing Execution System (MES)
    Equipment monitoring and controlDistributed Control System and Process Control System (DCS, PCS, SCADA)
    Batch record managementElectronic Batch Record (MES, EBR)
    Recipe managementElectronic formula and recipe management (MES, ERM)

    Quality control and quality assurance

    Quality managementQuality Management System (QMS)
    Lab data managementLaboratory Information Management System (LIMS)
    Document controlDocument Management System (DMS)
    Deviation, CAPA and audit trackingCAPA and Audit Management (CAPA, AMS)
    Electronic quality recordsEQR

    Supply chain and materials management

    Inventory and warehouse managementWarehouse Management System (WMS)
    Material tracking and traceabilityTrack and Trace, serialisation (T and T)
    Planning and resource optimisationEnterprise Resource Planning (ERP)
    Advanced production planningAdvanced Planning and Scheduling (APS)

    Maintenance and compliance

    Equipment maintenanceComputerised Maintenance Management System (CMMS)
    Regulatory compliance and documentationRegulatory Information Management and Compliance Systems (RIMS, CMS)

    Clinical

    Clinical trial follow-up and supply chainClinical Trial Management System (CTMS)
    Trial data captureElectronic Data Capture (EDC)
    Structured trial document managementElectronic Trial Master File (eTMF)
    Patient consenteConsent
    Randomisation systemsRandomisation systems

    借助 QbD Group 与 delaware 加速您的数字化转型

    通过我们与 delaware 的战略合作伙伴关系，我们将深厚的 Life Sciences 专业知识与一流的数字技术相结合。共同推动组织实施 SAP 等强大系统，实现从第一天起就经过充分验证、合规且与您的流程高度一致。

    更快实现价值

    加速数字化转型，无需因合规瓶颈而延误，同时确保全面的法规保障。

    随时可接受检查的系统

    每个解决方案从第一天起就经过验证并具备审计就绪能力。

    降低风险

    避免系统验证和法规错配中的常见陷阱。

    卓越运营

    通过集成、合规的数字系统推动效率提升。

    实践案例

    我们帮助 Red Cross Flanders 选择并实施了一套符合其独特流程的全新质量管理系统 —— 从设计研究到完整验证和迁移计划。
    阅读案例研究 →

    STAGE FOUR

    Standardised, digitalised, automated. What comes next.

    Once your systems are connected and your data is governed, AI stops being a risk and starts being an advantage. Our AI Transformation Program puts governance, classification and lifecycle assurance in place across every site.

    QbD Group 专业能力

    为什么选择QbD Group

    您值得信赖的合作伙伴

    QbD Group 提供全面的数字化服务套件，旨在为您的组织创造最大价值：

    深厚的行业专业经验

    在 pharma、biotech 和 medical devices 领域拥有可验证的业绩。

    供应商选型专业经验

    我们的团队比较多种经过验证的系统，并就最适合您的流程、风险画像和预算的方案提供建议 —— 避免代价高昂的错配并确保长期成功。

    技术中立的方法

    我们根据您的需求而非供应商关系推荐最合适的解决方案。

    全生命周期支持

    从流程梳理和软件选型到验证、培训和持续合规。

    专注于长期成功

    我们在每一步都与您合作，确保可持续的数字化转型。

    FAQ

    常见问题

    聊聊软件

    从系统验证到数字化转型,我们的软件专家随时为您提供支持。

    联系我们