Applications / Use cases / Client Case Merck®: Digitalization of Forms

CLIENT CASE: Merck KGaA®
Digitalization of Forms

The application developed for Merck KGaA enabled the digitalization of 70 paper forms, representing 12,000 executions per year.

It allows Merck® to achieve:

A productivity gain equivalent to more than 4 FTEs (Full-Time Equivalents) per year
Simplified compliance
Optimized processes

Context

Merck KGaA® handles thousands of paper forms each year, leading to high costs, delays, and potential errors. As part of their digital transformation strategy, Merck® entrusted GxpManager with the task of digitalizing its most critical forms.

The GxpManager form digitalization application has been implemented at three Merck sites in Switzerland since 2020:

Two sites in Vevey (one development site and one production site)
One production site in Aubonne

Merck is one of the world’s leading providers of products and services for the life sciences sector. Merck develops solutions for research, development, and production in biotechnology. Their solutions support researchers in both small laboratories and large-scale industrial operations.

With a team deeply committed to innovation, Merck continually develops cutting-edge products and techniques to meet the evolving needs of the industry.

Challenges

Managing thousands of paper forms across multiple sites poses several challenges for Merck®:

High costs associated with printing and transportation
Delays in validations, often worsened by frequent errors, such as missing or incorrectly filled fields
Lack of traceability and manual document handling, which complicates maintaining regulatory compliance and directly impacts operational efficiency.

To address these issues, Merck® identified the need for a solution that could digitalize processes, ensure data integrity, and simplify workflow management.

The Digitalization Solution

Merck once again chose to partner with GxpManager for this paper from digitalization project. A previous application was already in place at Merck for the digitalization of their Master Data Management process.

GxpManager deployed a tailored digitalization solution for Merck®, which included:

The digitalization of 70 critical forms used across three sites,
Representing approximately 12,000 executions per year.

This solution incorporated:

Automated workflows with email notifications,
Electronic signatures,
Secure archiving, eliminating document loss and input errors,
Simplification of existing processes,
Complete traceability of forms, ensuring data is accessible and reliable for optimized management.

The GxpManager Service Center

Today, Merck® leverages the GxpManager Service Center for on-demand requests to digitalize forms. A simple form can be produced within 3 to 4 days through our service center.

For example:

Request submitted on Monday
Configuration completed on Tuesday
Modifications made on Wednesday
Deployment to production on Thursday

Thanks to this streamlined process, GxpManager has already digitalized more than 70 forms for Merck®, significantly enhancing their operational efficiency and compliance.

Results

Through the digitalization of forms, Merck® has achieved:

A productivity gain equivalent to more than 4 Full-Time Employees (FTEs) per year
The elimination of QA rejections caused by incomplete fields
Simplified audits with enhanced compliance and strengthened traceability

Users now benefit from an intuitive solution, while management can access dashboards and performance indicators (KPIs) to effectively monitor activities.

This digital transformation has not only improved internal processes but also enhanced the security and integrity of data.

Time saved by Merck per year
in FTEs (Full-Time Employees)

Testimonial

Valentin Martin
Global Manufacturing Intelligence Lead at Merck Group

“They are very open to feedback. It’s great to work with them because we collaborate in an iterative mode. Whenever we spot something or have a desire for improvement, we are heard. Often, it’s implemented in one or two subsequent versions. It’s a strong collaboration.”

Full Testimonial Video (in French)

Presented at the Polepharma Congress in Chartres – November 2024

Merck® Use Case:
Optimization of the Pharmaceutical Release Process

At Merck, the batch release process for pharmaceutical production poses a significant challenge due to the complexity and multiplicity of systems involved (SAP, MES, LIMS, quality management system, etc.).

Identifying bottlenecks related to the availability of critical documents—such as Certificates of Analysis (COA), Certificates of Conformance (COC), and other regulatory documents—is often time-consuming. This lack of centralized visibility leads to delays, loss of productivity, and an increased risk of non-compliance, which can directly impact time-to-market.

Solutions with GxpManager

Centralized View of the Release Process
Merck leverages GxpManager to centralize all critical data and documents related to batch release processes. This solution automatically aggregates information from SAP, MES, LIMS, and the quality management system, providing a consolidated overview.
Identification and Resolution of Bottlenecks
With an intuitive interface, GxpManager enables Merck to immediately identify which documents or processes are delaying batch release. For example, an interactive dashboard highlights if a COA, COC, or other document is missing, along with the individual or team responsible for its validation or availability.
Integration and Automation
GxpManager integrates with Merck’s existing tools through APIs, ensuring smooth operations and swift actions. Users can access blocking tasks and responsible parties directly, minimizing back-and-forth communication and reducing execution time.

Results of Process Digitalization for Batch Release

Optimized Release Time: At Merck, the time required to identify and resolve bottlenecks has been significantly reduced, speeding up batch release.
Improved Cross-Department Coordination: Production, quality, and logistics teams work more seamlessly, thanks to the visibility provided by GxpManager.
Guaranteed Compliance: Centralized management ensures all required documents are available and compliant before batch release.
Increased Efficiency: The solution has reduced manual tasks, minimized error risks, and boosted team productivity.

For Merck, integrating GxpManager has transformed the batch release process into a smoother, faster, and more compliant operation, meeting the strict demands of the pharmaceutical industry.

Boost Productivity and Simplify Compliance with GxpManager
The No-Code platform for creating Quality, Safety, and Compliance applications.