Merck operates at the intersection of science, manufacturing and regulated quality. Across China, Germany, the United States, Korea and other markets, its teams manage records that directly affect product quality alongside the commercial agreements that keep suppliers, laboratories, service providers and internal operations moving.
Those two categories demand different controls. A GxP approval requires verified access, defined signature meaning, controlled sequencing and inspection-ready evidence. A supplier agreement needs speed, clear routing and reliable records without adding regulated steps that do not belong in the process.
Merck replaced its regional Adobe Sign setup with Nota Sign and established one enterprise eSignature platform with two strictly isolated operating environments: a GxP Workspace for regulated records and a Non-GxP Workspace for business agreements. The model now serves 30,000 users while keeping security, data residency, workflow policy and audit evidence aligned with each document’s purpose.
“With Nota Sign, we can support GxP and non-GxP workflows for 30,000 users on one platform—moving faster without compromising validation, traceability or audit readiness.”
— Global Quality & IT, Merck
The challenge
Science at scale creates two different agreement realities
Merck’s Life Science, Healthcare and Electronics businesses connect research, quality, production, procurement and commercial teams worldwide. China is a key deployment market spanning manufacturing, testing, bioprocessing materials, pharmaceutical production and a large supplier ecosystem. Teams in Germany, the United States, Korea and other regions add cross-border quality, technical, legal, procurement and commercial stakeholders to the same agreement lifecycle.
The challenge was not volume alone. Merck needed the right control model for every record.
GxP workflows included standard operating procedures, validation protocols and reports, change controls, quality agreements, supplier qualification records, training acknowledgements and regulated technical approvals. These records required identity controls, a clear reason for signing, an immutable audit trail and evidence that the designated roles completed each step in the intended order.
Non-GxP workflows included procurement contracts, statements of work, nondisclosure agreements, distribution and service agreements, supplier onboarding documents and internal business approvals. These agreements needed a faster path with fewer regulated actions, while retaining enterprise permissions, routing visibility and reliable evidence.
The previous model placed both categories too close together, forcing regional teams to rely on manual checks and follow-up outside the platform. China data residency, FDA 21 CFR Part 11 controls and governance across global teams became harder to administer at scale.
The solution
One platform architecture, two strictly isolated workspaces
Nota Sign gave Merck a clear operating model: use one enterprise platform, but never force regulated and non-regulated documents through the same environment.
The GxP Workspace runs with the Nota Sign 21 CFR Part 11 Module. It applies controlled authentication, signature-level credential confirmation, mandatory signing reasons, signature manifestations and time-stamped audit events. Each completed record includes the signed document and an exportable completion certificate.
The Non-GxP Workspace serves procurement, supply chain, legal, HR and commercial teams through approved templates, role-based permissions and automated routing—without unnecessary GxP steps.
The workspaces are strictly separated across administrators, user groups, templates, workflow policies, records and audit configuration. This prevents a business template from entering a regulated process and prevents regulated controls from being weakened for convenience. Merck gains centralized governance without blending two different risk models.
“The separation is operational, not cosmetic. Every team knows which workspace to use, every document follows the correct control set, and the evidence remains tied to the process that created it.”
— Quality Systems, Merck
Three decisions that made enterprise adoption work
1. Treat regional data hosting as part of the workflow design
For China-based signing, Merck uses Nota Sign’s Beijing data center to keep the operating model aligned with China’s Personal Information Protection Law requirements and local data-governance policies. For international and regional workloads, Nota Sign’s Frankfurt, Germany data center provides a European hosting option.
Regional deployment sits inside an enterprise security model built around SOC 2 controls, encryption in transit and at rest, role-based access, SSO and auditable administrator activity. Data location determines where a workspace operates, who administers it and how records are retained.
2. Encode GxP controls directly into the signing path
A compliant process cannot depend on users remembering the sequence from a separate procedure. Merck translated its approval logic into reusable Nota Sign templates and routing rules.
A validation record moves from document owner to technical reviewer and then Quality Assurance, with the final quality approver signing last. A quality agreement routes legal and supplier-quality review in parallel before authorized signatories act. Required fields, roles, signing reasons and authentication remain attached to the template.
Nota Sign enforces sequential and parallel routing, isolates recipient fields and records every action in a time-stamped audit trail. Signature manifestations bind the signer’s name, time and reason to the record. The final PDF is tamper-evident, and its completion certificate is ready for retention and inspection support.
3. Standardize the experience without forcing one language or one process
A regional platform succeeds only when employees, suppliers and external signers can complete work without translation becoming a new bottleneck.
Nota Sign provides nine live interface languages: Simplified Chinese, Traditional Chinese, English, Thai, Spanish, Russian, Indonesian, Vietnamese and Portuguese. Merck’s China teams use a localized interface, while teams and external parties in Germany, the United States, Korea and other markets complete cross-border workflows in English. The underlying routing, evidence and administration remain consistent.
Merck standardizes templates by document family rather than forcing a universal process. GxP records receive regulated controls, routine business agreements use a shorter path, and high-value or cross-border agreements add legal, procurement, finance or business-owner steps.
How Merck uses Nota Sign
Global GxP quality and regulated operations
Quality and operational teams use Nota Sign for SOP approvals, validation documentation, change controls, quality agreements, supplier qualification records, training acknowledgements and regulated technical records.
Each workflow identifies the owner, reviewers and final approver before signing begins. Authentication, signing meaning, the audit trail and completion certificate remain part of the evidence package.
Non-GxP supply chain and business agreements
Procurement and supply-chain teams use the Non-GxP Workspace for supplier agreements, purchase-related documents, service contracts, confidentiality agreements and onboarding records.
Complex paths connect China-based and global business owners with procurement, legal, finance and supplier signatories across regions. Parallel review, reminders, status visibility and template controls eliminate manual chasing. Routine non-GxP agreements now complete within the same business day. Domestic China workflows retain evidence aligned with the PRC Electronic Signature Law.
The results
From document chasing to controlled execution
Merck’s deployment turned eSignature from a standalone tool into a governed agreement operation.
The platform now serves 30,000 users across China, Germany, the United States, Korea and related global regulated and business workflows. GxP approval cycles run 70% faster, driven by reusable templates, enforced routing, digital review and immediate access to completed evidence. Manual follow-up and record reconciliation fell by 80% as teams moved status checks, reminders, routing and completion records into the platform.
The impact extends beyond cycle time. Quality teams enter audits with consistent evidence, IT administers separate risk environments through one platform, and procurement gains faster supplier execution. Speed comes from making the correct control automatic.
“Nota Sign gives us a scalable model for regulated and business signing. GxP records follow validated controls, business agreements move at operational speed, and both remain visible to the teams accountable for the outcome.”
— Global Quality & IT, Merck
A stronger operating model for global life sciences eSignature
Merck’s approach establishes a practical standard for global life sciences organizations: separate GxP and non-GxP environments, place regional data requirements into the architecture, encode quality controls into the workflow and keep the signer experience consistent across languages and markets.
Every agreement now enters the correct workspace, follows an approved route and produces evidence matched to its regulatory or business purpose.
About Merck
Merck is a global science and technology company operating across Life Science, Healthcare and Electronics. Its teams develop products and technologies used in scientific research, biopharmaceutical manufacturing, healthcare and advanced electronics. The customer story spans teams and workflows in China, Germany, the United States, Korea and other global markets.
