TRACKWISE QUALITY SUITE

The industry standard in Quality Management, now with new modules for PQR and QMR

LEARN MORE

TrackWise Digital and TrackWise QMS

Our leading QMS platforms embed quality across the supply chain to optimize manufacturing and quality performance.
AI-Enabled Quality
Manufacturing Quality
Digital Shop Floor
Supply Chain Quality
Quality Content Management
Integrated Risk Management
Post-Market Surveillance
R&D and Clinical Quality
AI-Enabled Quality >

AI has the greatest potential to transform quality systems and shift from reactive to proactive quality. Apply AI to augment decision-making by suggesting categories, risks, and reportability and correlating complaints and other quality events. See how our AI-powered QMS boosts productivity, reduces investigation time, and increases patient safety.

Manufacturing Quality >

Optimize manufacturing performance with fully integrated digital quality processes and intelligent workflows. Learn how our digital approach connects the data across manufacturing to efficiently manage all quality events.

Digital Shop Floor >

Industry 4.0 meets Quality 4.0. Integrate and optimize operations using the latest technologies to connect quality and manufacturing data for actionable insights, improved product disposition, and efficient batch release.

Supply Chain Quality >

Virtualize and simplify supplier quality management. Seamlessly collaborate with your expanding network of suppliers and contract manufacturers on quality events, including CAPA, change requests, and audits. See how TrackWise Quality solutions can help you mitigate the complexity of modern global supply chains.

Quality Content Management >

Centralize and digitize document management and training management on a single platform. Quality teams and stakeholders can instantly access documents and take action to gain efficient and effective quality, regulatory, and document lifecycle management.

Two users sharing screen to access applications Integrated Risk Management >

Proactively manage risks of pharmaceutical products, medical devices, and other life science products with built-in templates to meet ISO 14971 and ICH Q9 requirements. Learn how our Life Sciences solutions provide the insights you need to mitigate risk and improve patient safety.

Post-Market Surveillance >

Gain valuable product insights and effectively manage customer complaints to reduce product safety risk, achieve regulatory reporting compliance, and improve the efficiency of post-market surveillance processes.

R&D and Clinical Quality >

Optimize quality processes to support GCP/GLP requirements and strengthen regulatory responsiveness. Discover how TrackWise Quality solutions help you ensure compliance and reduce costs and risk.

New Thought Leadership

Connecting you to key insights and resources for smarter quality management.
SEE ALL RESOURCES

Shaping the Future of Proactive Quality

TrackWise QMS solutions help companies bring products to market by leveraging the highest level of quality management processes, including advanced QMR and PQR capabilities, and technology innovations to be ready for what’s next.
Simple, Smart Quality Management System Reviews

Proactive quality hinges on the power to harness quality data and apply advanced technologies—generative AI, natural language processing, advanced analytics—to manage quality issues and reduce downstream risks. Augment decision-making and gain real-time insights to proactively detect and address issues before they become more impactful. ​
With QSMR capabilities, leverage real-time data insights to monitor quality metrics across all levels, ensuring compliance and addressing risks proactively.

Unmatched Expertise

Quality is our foundation. Leading companies have trusted and relied on our quality solutions and expertise for nearly three decades to meet rigorous standards and turn quality into a strategic advantage. 

With proven Product Quality Review workflows, ensure your processes meet global compliance standards while staying ahead in operational efficiency.

Everything You Need, All in one Place

Gain a single source of truth and view of quality events. From the shop floor to the boardroom and across the value chain, monitor performance and streamline reporting with on-demand digital dashboards, optimized workflows and real-time insights.

The inclusion of QMR dashboards and PQR reporting tools ensures comprehensive monitoring and effortless communication of product and operational quality data.

Faster Value and Harmonization

Simplify, standardize, optimize. Whether you’re just getting started or need to harmonize globally, our intelligent fit-for-purpose quality processes built on industry best practices support GxP compliance and deliver rapid value. 

Establish a Culture of Quality

Quality is everyone’s responsibility. Our solutions make it easy to access and collaborate on quality documents with both internal and external partners. With our modern interface, users can quickly navigate and manage quality from any device, anytime, anywhere.

Through integrated PQR and QMR systems, foster a collaborative approach to quality management and ensure every stakeholder has the insights they need to contribute to excellence.

Quality Management System (QMS)

TrackWise Digital
Our TrackWise Digital® QMS solution is an industry-leading quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision-making.
Learn more
TrackWise QMS
TrackWise® is the world’s leading on-premise QMS software. TrackWise offers several industry best-practice workflows, bringing all your quality processes together in a single place.
Learn more
TrackWise AI
The world’s first AI-enabled capabilities specifically designed to improve quality and support Good Manufacturing Practices (GMP).
Learn more

Comprehensive Quality Management Beyond QMS

TrackWise Product Quality Review
Modernize the Annual Product Quality Review (APQR) Process
Learn more
TrackWise Quality Management Review
Learn how Honeywell is transforming the quality management review process with HQMR
Learn more

顧客の成功事例

効率の2倍向上

未完了のトレーニング記録を1％未満に削減し、調査のルーティングおよび承認時間が2～3日から1日未満に短縮されました。
年間800時間の節約

すべての変更記録が手元にあります。効率化されたワークフローにより、CMO（契約製造業者）との変更管理プロセスが迅速化され、全体的な変更管理が改善されました。
品質のグローバルデジタルトランスフォーメーション
17のグローバル拠点および広範なパートナーネットワークにわたる品質管理のデジタル化により、運用効率、能力、ターンアラウンドタイム、顧客サービスを改善します。
25K
文書
400
監査

SGSはTrackWise Digitalを導入し、25,000を超える項目をデジタル化して排除しました。これにより、紙ベースで文書中心の環境から、17以上の拠点と数百のパートナーを最先端のデジタルプラットフォームでつなげました。SGSがTrackWise Digitalを選んだ理由をご紹介します。

  • 直感的なユーザーインターフェースと使いやすいダッシュボード
  • ライフサイエンス業界での優れた評価と高い使用率
  • 品質、苦情、文書、トレーニング、サプライヤー品質、CAPAを含む包括的なモジュール
  • 監査の返信を直接提出できる堅牢な監査管理機能により、年間400回以上の監査を実施しやすくなりました

成功事例についてさらに詳しくお読みください。

TrackWise Digitalは、導入後すぐにMcKessonのビジネスモデルに非常に適しており、元々TrackWiseを使用していた私にとって、TrackWise Digitalの利点とユーザー体験を示すことができたのは非常に楽しいことでした。
Barry Cook
VP of Quality Operations | McKesson
私たちは年間平均で45万件の苦情を処理しており、今年は少なくとも50万件を処理する予定です。AIは私たちの処理能力を向上させ、規模を拡大する手助けをしてくれます。
Saku Tuominen
Business Administrator | Orion Corporation
品質管理における深い専門知識と革新的なデジタル品質プラットフォームを持つ彼らのおかげで、製品ライフサイクル全体にわたる品質に関する課題を完全に可視化でき、今後の成長と製品パイプラインを支援する適切なパートナーを得ることができました。
Judy Coddington
Vice President, Quality Assurance | Daiichi Sankyo Inc.
TrackWise Digitalは、私たちの選定基準を満たした唯一のQMSソリューションでした。GMPコンプライアンスとバリデーションにおける比類のない専門知識に対する彼らの評価は、成功する導入と長期的なパートナーシップを享受できるという自信を私たちに与えてくれました。
Jasmin Jivraj
Head of Quality Assurance | Bene Arzneimittel GmbH
TrackWise Digitalへのアップグレードにより、私たちは組織内での品質の卓越性を提供するという使命をさらに進め、サプライチェーン全体でのトレーサビリティを向上させることができます。
Nick Walp
VP, Quality Affairs | American Regent
SEE MORE STORIES

Quality Management Solutions

Audit Management
CAPA
Change Management
Complaints Management
Deviations and Quality Events
Document Management System
Nonconformance
Out of Specification
Quality Risk Management
Supplier Quality Management
Training Management

Let’s talk about how TrackWise Quality Suite can help

No matter where you are in your digital journey,
we have solutions for you
Get in touch