handshake
An IT Specialist for the Pharma Industry

The pharmaceutical industry needs to adhere to stringent quality standards to ensure the safety and efficacy of its products, protect public health, and maintain trust in the industry. handshake, a specialist in pharmaceutical IT, enables pharmaceutical companies to achieve this feat by fulfilling legal and FDA/AGES requirements, documenting and controlling production processes and reducing the effort required for validation.

The company was founded by Anton Neuber, a master craftsman in electromechanics, electrical engineering, and office machine mechanics, as well as a communication scientist. In the initial days, its goal was to provide technical support to clients and distribute adaptive technology, but this quickly expanded into project management and qualification support, specifically in the realm of data integrity services.

“We recognized the need for comprehensive solutions that could help pharmaceutical companies comply with the data integrity and GxP requirements for the documentation and qualification of activities that influence product quality. This prompted us to develop our own software products, Smart Audit Trail©, Smart Log Book©, and Smart Document System©,” says Anton Neuber, founder and CEO, handshake.

Smart Audit Trail© controls and monitors computer activities in production and other sensitive areas. It enhances the audit trail functionality, particularly in Windows-based computers, ensuring compliance with EDA, FDA, GMP, GLP, and local Food Safety Agencies. It also records user activities on computers and captures settings changes, which is crucial to prevent any errors that could pose significant risks to lives.

The Smart Audit Trail’s remote review capability, together with intelligent features for data analysis, delivers comprehensive reports. This paperless solution can store the generated report in a centralized server, eliminating the need for personnel to access the audited systems physically.

The company’s Smart Log Book© solution serves as an electronic replacement for paper-based logbooks. The detailed documentation streamlines processes and provides a comprehensive account of issue identification, resolution, and verification. Beyond digitization, Smart Log Book’s electronic signature feature with recorded timestamps facilitates enhanced event-tracking capabilities, preventing unauthorized data tampering and eliminating the risk of falsely attributing actions to others.

handshake’s Smart Document System© is a web-based document management system using electronic form templates to replace traditional paper forms. For users, the document handling is very similar to MS Office, and the easy-to-use web-based interface elevates user experience without extensive training requirements. Optional integration of instruments, serialization integrity and automatic data retrieval is supported. This minimizes the chance of human errors.

We recognized the need for comprehensive solutions that could help pharmaceutical companies in the documentation and qualification of activities that influence product quality. This prompted us to develop our own software products, Smart Audit Trail©, Smart Logbook© and Smart Document System© for the GXP-compliant production environments

handshake’s client engagement journey begins with a thorough understanding of their objectives and internal requirements. Following this, functional goals, key indicators for project success, involved departments, potential impact on stakeholders and any external systems influencing the project are identified. handshake then conducts workshops for stakeholders to garner a shared understanding of project goals, which helps in the successful project execution within the predetermined timeframe.

What sets handshake apart from its competitors is its commitment to involving stakeholders from the initial phase to project execution—communicating changes, outlining expectations, and ensuring proposed solutions are feasible and acceptable to all parties.

handshake’s three decades of experience in qualification and project management support, in conjunction with Neuber’s high level of certifications, is paving the way for the company’s continuous growth.