Stryker operates at the intersection of medical technology, quality management, and global commercial execution. Its teams need to move quickly, but every regulated approval must remain controlled, attributable, and ready for inspection.
Across China and Asia Pacific, the company needed to replace Adobe Sign with a platform designed for local operating conditions and global life sciences requirements. Nota Sign gave Stryker a unified regional foundation for GxP signing, China domestic agreements, and Non-GxP workflows connecting users in China and the United States.
The impact was immediate: 96% of envelopes were completed within three days, physician-clearance time improved by 98% from a 20-day baseline, and customer satisfaction increased by 65%.
The challenge
Adobe Sign no longer matched Stryker’s China and APAC operating model
For Stryker, electronic signature is part of a broader operating process. A single record can involve quality, regulatory, clinical, commercial, legal, procurement, and operations teams across several jurisdictions.
In China, the existing Adobe Sign setup created a gap between the company’s global signing standard and the realities of local access, data governance, identity verification, and enterprise-seal usage. Stryker needed a replacement that worked consistently for China users while remaining connected to APAC and U.S. teams.
The company also needed to distinguish between two fundamentally different categories of work.
GxP records—such as validation approvals, design-control reviews, change controls, deviations, CAPA records, and controlled training acknowledgements—require strict controls over identity, authority, signature meaning, sequence, integrity, and auditability. These workflows must support FDA 21 CFR Part 11-regulated processes and Stryker’s computerized-system-validation model.
Non-GxP agreements—such as NDAs, supplier contracts, statements of work, distributor agreements, sales documents, and internal business approvals—need a faster path. Applying the full GxP control set to every document would slow teams down without improving the legal or operational outcome.
Stryker needed one platform that could handle both categories without blurring the boundary between them.
“For our quality and regulatory teams, speed only counts when the process remains controlled. We needed the right people involved in the right sequence, with a record that was straightforward to retrieve.”
— VP, Quality and Regulatory Affairs, Stryker
The solution
One platform, two governed signing paths
Nota Sign replaced Adobe Sign for Stryker’s in-scope China and APAC workflows and established a clear operating model: regulated records enter a dedicated GxP Workspace, while everyday agreements use a streamlined Non-GxP workflow.
This classification-first approach applies controls according to the record’s intended use rather than the department sending it.
For GxP workflows, Nota Sign provides unique user identities, enterprise SSO, multi-factor authentication, role-based permissions, controlled routing, required signing reasons, signature manifestations, time-stamped audit trails, and tamper-evident completed records.
For Non-GxP workflows, teams can prepare, review, route, sign, seal, track, and archive agreements without carrying the additional steps reserved for regulated records.
The same platform also supports China domestic execution through individual electronic signatures and enterprise electronic seals. Identity evidence, signer intent, timestamps, document integrity, and completion records are retained as one evidence package, supporting transactions governed by the Electronic Signature Law of the People’s Republic of China.
Nota Sign’s China-based data environment, access controls, retention configuration, security logging, and governed integrations support Stryker’s compliance with the Personal Information Protection Law. China data remains managed within the regional operating model, while authorized cross-border participants can complete the approvals and agreements assigned to them.
How it works
1. GxP approvals follow a Part 11-ready process
A China-based quality team can initiate a design review, process-validation report, deviation approval, CAPA decision, or change-control record in the GxP Workspace.
Nota Sign routes the record to the required reviewers and approvers in sequence. Each participant authenticates using the configured enterprise identity controls and applies a signature with an explicit meaning such as “Reviewed,” “Approved,” or “Responsible.”
The completed package records the signer’s identity, signature meaning, date and time, workflow events, and final document integrity. The signed record and its audit evidence can then be transferred to Stryker’s controlled document or quality-management environment.
This removes manual status chasing without weakening the controls required for regulated work. As a result, 96% of envelopes are completed within three days.
2. Physician clearance moves from weeks to hours
Physician-clearance workflows previously depended on email follow-up, document rework, and limited visibility into the next action. A process with a 20-day baseline could stall whenever a form was incomplete, an approver was unavailable, or the current owner was unclear.
With Nota Sign, the clearance package is prepared once, routed to the correct physician and internal reviewers, and tracked through completion. Required fields prevent incomplete submission, automated reminders keep the request moving, and the completed record is returned with a full signing history.
This connected workflow reduced physician-clearance time by 98%, turning a 20-day process into a same-day digital experience.
3. China domestic agreements use reliable signatures and electronic seals
For supplier, service, procurement, and other domestic agreements, Stryker can verify the participating individuals and enterprises before execution.
Authorized representatives apply electronic signatures, while legal entities apply the configured electronic seal. Nota Sign captures authentication results, signing authority, intent, timestamps, and document-integrity evidence.
The agreement and evidence report remain connected, giving legal and procurement teams a clear record of who signed, for which entity, and against which document version. This supports reliable electronic execution under China’s Electronic Signature Law and reduces the operational burden of physical chops, courier delivery, and scanned copies.
4. Non-GxP agreements connect China and U.S. users
A U.S.-based agreement owner can initiate an NDA, distributor agreement, sales contract, statement of work, or supplier document and route it to colleagues or counterparties in China.
Internal reviews, individual signatures, and enterprise seals take place in one visible workflow. Each participant sees the next action, and agreement owners can monitor progress without switching between regional tools or reconstructing status from email threads.
After completion, Stryker receives the final executed agreement and a signing report containing recipient details, access events, authentication results, signature timestamps, and integrity evidence.
This consistent experience improved predictability for internal users and external customers, contributing to a 65% increase in customer satisfaction.
“Commercial teams can move a request forward with confidence because ownership, status, and the next action are visible in one place. Important work no longer stalls between separate regional tools.”
— VP, Commercial Operations, Stryker
The results
Faster regulated work with stronger regional control
Nota Sign gave Stryker more than an Adobe Sign replacement. It created a signing model designed around record risk, regional regulation, and the way global medical technology teams actually work.
96% of envelopes completed within three days. Controlled routing, required fields, automated reminders, and visible ownership reduced avoidable delays across regulated workflows.
98% faster physician clearance. A process that previously took 20 days became a same-day digital workflow, giving commercial and clinical stakeholders a faster path from request to approval.
65% higher customer satisfaction. Customers and partners received a more predictable signing experience with fewer follow-ups, clearer instructions, and faster completion.
The platform also gave Stryker a stronger governance foundation. GxP records now follow a dedicated FDA 21 CFR Part 11-ready path. Non-GxP agreements retain business speed. China domestic contracts use locally appropriate signatures and electronic seals. U.S. and China users collaborate through one cross-border workflow.
The result is a controlled, scalable model that keeps regulated work moving without treating compliance as an afterthought.
About Stryker
Stryker is a global medical technology company with products and services across MedSurg, Neurotechnology, and Orthopaedics. The company has 56,000 employees, serves customers in 61 countries, and impacts more than 150 million patients annually.
Its global scale requires quality, commercial, legal, procurement, and operational teams to coordinate across business units, systems, and regulatory environments. Nota Sign supports that coordination with a unified electronic-signature platform for regulated and business-critical workflows.
