Introduction of anicomply: The New Electronic Batch Recording (EBR) Program on the Market
Digitalization in the pharmaceutical and biotechnology industries is continuously advancing. At the same time, the pharmaceutical industry faces significant challenges: strict regulations (validation, ER/ES, audit trail, data integrity, data consistency, etc.) must be met, while customers simultaneously expect innovations, fast delivery times, and a wide product range – all with consistently high, defined quality.
A Highly Flexible, Validated EBR – The Key to Success
A particularly important aspect is electronic batch recording (EBR), which makes a decisive contribution to quality assurance and compliance with regulatory requirements. This is where anicomply, an innovative web application for EBR, enters the market. Although the software has just been officially launched, it has already proven itself successfully over the past three years at a DAX company. A modern EBR system that allows the user to create recipes from predefined building blocks within minutes and then publish them digitally is the answer to current requirements.
The USPs of anicomply: Increased Efficiency and Flexibility
A significant advantage of anicomply is the quick configuration and easy publishing of recipes. Where conventional systems take weeks or even months for these processes, these steps can be completed with anicomply in just a few hours. This drastic reduction in lead times gives users the flexibility needed to respond more quickly to market demands and regulatory changes, which is a major competitive advantage, especially in the highly dynamic pharmaceutical industry. Additionally, anicomply offers a user-friendly and location-independent operation through its intuitive web application. This allows teams worldwide to access the software and collaborate closely, optimizing the production process.
Conclusion: anicomply Offers Digital Publication and Real-Time Monitoring
Once production data is captured, the system can automatically publish reports and batch records digitally. Production data can be transferred live to data historians or data lakes, enabling real-time production control and quality improvement.
GxP Compliance and Validity – No Room for Compromise
Compliance with strict regulations such as GxP (Good Practice) is essential for companies in regulated industries. anicomply was developed with these requirements in mind and is GxP-validatable. This gives companies the assurance that all production processes managed with the software meet the highest regulatory standards.
Features That Build Trust and Security: Audit Trail, Electronic Signatures, and the Four-Eyes Principle
Security and traceability are at the heart of anicomply. Every action is documented in a seamless audit trail, allowing all changes and activities to be traced at any time. This is particularly important during audits and inspections by authorities. Data security and integrity: protection against unauthorized access and traceability of all changes. Another highlight is the implementation of electronic signatures (ER). These allow all necessary documents and processes to be signed digitally, saving time and reducing paper consumption. anicomply follows the four-eyes principle to ensure that every critical decision is reviewed and approved by at least two authorized persons. This strengthens process integrity and reduces the risk of errors.
Benefits for the Pharmaceutical Industry
With anicomply, companies have a powerful EBR tool at their disposal that not only impresses with its speed and flexibility but also meets the highest standards in terms of compliance and security. The proven practice at a DAX company underscores the confidence in this software, which is now preparing to conquer the market and fundamentally improve production processes in the pharmaceutical and biotech industries.
- Improved Compliance: Fulfillment of all regulatory requirements and reduction of non-compliance risk.
- Higher Production Efficiency: Shortened production times and more efficient use of resources through digital batch documentation and dynamic recipe adjustment.
- Error Reduction: Minimization of manual error sources through automatic reading and processing of recipes. This increases product quality and reduces the risk of production failures or recalls.
- Cost Savings: Long-term cost savings through improved efficiency and error reduction, both in production and in compliance with regulatory requirements.
Conclusion: A Future-Proof System for the Pharmaceutical Industry
A highly flexible, GxP-compliant, and validatable EBR system like anicomply represents a significant advancement for the pharmaceutical industry. The digitalization of batch recording not only offers a more efficient production method but also increased compliance security. Given the increasing regulatory requirements and the pressure to optimize processes, investing in a modern EBR system is a clear step towards the future. Implementing such a system enables pharmaceutical companies to respond agilely and efficiently to market changes while meeting the highest quality and safety standards.
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