Smart Document System©
How many systems do your employees need to start a production run or an experiment?
- Electronic forms and records - no paper
- All checklists, forms & protocols in digital format
- A tool with interfaces to your existing infrastructure
- Captured data available directly in database format
- Avoid significant licensing costs
- Be compliant to GxP obligations
- Up to 10 x faster Reviews
Core industries we serve
- Pharma
- Biotech
- Chemicals
- Cosmetics
Paper to digital conversion process
Smart Document System© at a Glance
Form-based documentation system with interactive interfaces to production and laboratory equipment, as well as ERP, LIMS, MES.....
Data is available immediately after entry into the form for (AI) data mining, trending, and initiation of corrective actions.
Further development, review, and approval of new form versions is possible independently of using the forms.
A digital timestamp avoids any possibility of entries being out of order.
Advantages of Smart Document System© compared to other digital form products.
- Smart Document System© reduces training requirements through a single, intuitive interface that automates data flow and background system integration.
- Intuitive form template editor that allows user-driven changes without developer involvement.
- Seamless integration with lab and production equipment ensures error-free data capture and faster, more efficient reviews.
- Document review can be performed location independent.This allows central review organisation and performance.
Review by exception ability
- Plausibility checks for automated alerting
- Summary of values outside set boundaries
- Highlighting of unexpected values

Frequently Asked Questions
How long does the implementation of Smart Document System© take?
The scope and complexity of the required forms determine the implementation effort. To streamline form creation, we use dynamic text modules and form templates — including reusable form blocks for recurring elements. System interfaces ensure seamless integration into existing IT infrastructures. The solution is available both on-premise and in the cloud.
How much training is required for employees?
Thanks to its familiar look and feel inspired by common Office applications, Smart Document System© significantly reduces the training effort for users. While the administration and interface configuration require solid IT expertise, Smart Connector Service and OPC infrastructure enable automated data exchange with analytical and production equipment. This establishes Smart Document System© as a true ‘Single Point of Control’ for users. Data can also be sent to and retrieved from ERP, eQMS, LIMS and other systems directly within the form fields — eliminating the need for users to be trained in those external systems.
What calculation functions and system integrations can be utilized?
Smart Document System© offers calculation capabilities comparable to Microsoft Excel®, enabling flexible and formula-based value generation within forms.
For data exchange with analytical instruments and production equipment, the system supports both OPC and Smart Connector Service infrastructures.
With SDS Exchange, values can be shared across multiple Smart Document System© documents — even across different Smart Document System© instances — ensuring seamless interoperability.
Database Connectors enable direct integration with external database-driven systems, allowing for real-time data exchange.
Standardized parameter lists ensure consistent terminology and enforce syntax rules, supporting data integrity and harmonization across the system.
Is Smart Document System© GxP and 21 CFR Part 11 compliant?
Yes, Smart Document System© meets all requirements for data integrity, GxP, and 21 CFR Part 11 compliance. When creating forms, all specifications related to audit trail and data integrity must be implemented according to the requirements of the respective systems.