Use as a Tool for Production Documentation
- Client: Mid-sized CDMO – European production site
The Challenges
Our medium-sized pharmaceutical client had already explored the topic of Electronic Batch Records (EBR) and the systems behind them. However, many of these solutions appeared overly complex for their specific needs, offering too many features and requiring significant customization efforts. Budget considerations also played a key role in the decision-making process.
The Solution
Smart Document System<sup>(c)</sup> was introduced as a cost-effective solution for production documentation. As requested by the customer, the transition was intentionally designed to closely mirror the paper-based process, minimizing training needs and boosting user acceptance.
Existing Word documents were imported and adapted for a template- and database-driven system. Active Directory-based user management now provides full transparency over who was involved in the production process, when, and how. Integrated version control ensures that only the most recently approved forms are used. Each step is documented via the integrated audit trail, guaranteeing full traceability.
The Result
The paperless production documentation process led to shorter throughput times and increased process reliability. Data availability and transparency improved significantly, partly because manual input errors were eliminated. Immediate data availability enabled timely analyses and early interventions, helping to reduce production downtime and enhance transparency. Trained and authorized customer employees value the ability to independently adapt the forms and appreciate the system’s flexibility, which allows it to be rolled out across various other areas of the company.
