Transition from paper-based training to electronic training

A German pharmaceutical company based in Heidelberg, partnered with Zamann Pharma Support to transition from a traditional paper-based training system to a robust electronic training management solution. The goal was to improve training efficiency, ensure regulatory compliance, and streamline record management processes in alignment with EU GMP requirements.).

Challenges Faced

Outdated System: The client’s paper-based training system was labor-intensive, prone to human error, and difficult to manage for audits.
Compliance Risks: Manual processes made it challenging to ensure complete and up-to-date training records, creating potential risks during regulatory inspections and internal audits.
Scalability Issues: With company growth, managing training requirements for a larger workforce across multiple departments became increasingly complex.
Change Management: Transitioning employees accustomed to paper-based systems required a structured approach to manage resistance and ensure adoption.

Zamann Pharma Support’s Approach

Project Kick-Off and Analysis:
1. Conducted stakeholder meetings to assess current training processes, pain points, and objectives.
2. Reviewed regulatory requirements (FDA 21 CFR Part 11 and EU GMP) to ensure the new system’s compliance.
System Selection and Validation:
1. Supported the client with the creation of user roles definition, implementation and rollout of the electronic training management system (ETMS) to meet their operational needs and regulatory standards.
2. Provided Computer System Validation (CSV) support to check the validate system documentation in line with FDA and GAMP5 guidelines.
Process Redesign:
1. Developed standardized workflows for training assignment, tracking, and documentation.
2. Created templates for training content, assessment records, and system-generated reports to replace manual documentation.
Employee Training and Change Management:
1. Conducted workshops and hands-on sessions to train employees on the new system.
2. Implemented a phased roll-out strategy to ensure smooth adoption and minimize disruptions.
3. Provided tailored support to address user concerns and monitor progress during the transition phase.

Results Achieved

Enhanced Efficiency: The transition significantly reduced administrative workload and streamlined training processes.
Improved Compliance: The electronic system ensured accurate, complete, and audit-ready training records, meeting EU GMP requirements.
Scalable Solution: The new system accommodated company growth, providing flexibility to manage training for a larger workforce.
Employee Adoption: Through structured training and change management, employees adapted quickly to the new system, resulting in minimal resistance.
Audit Readiness: The client’s training records were successfully reviewed during a regulatory inspection, with no findings reported.

Client Testimonial

“Zamann Pharma Support provided exceptional guidance in transitioning our training processes to an electronic system. Their structured approach, from user-definition to employee training, ensured a smooth and compliant implementation. The new system has transformed our training efficiency and audit readiness, and we couldn’t be more satisfied with the results.”

Contact Us

Need help? Don't hesitate to get in touch

First Name*

Last Name*

Email*

Phone number*

Role*

Department*

Country

Industry

Question submitted

Zamann pharma support is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.

Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the Zamann Pharma Support GmbH.

I consent to the privacy policy and understand that my personal data will be stored and processed*

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com