Pharma Instrument Qualification and Maintenance Software Solutions
AnaTox is a software and service company for maintenance and qualification of LC/GC/MS instruments established in 2004. The main topic is the development and support of automated qualification tools and software for chromatographic equipment. AnaTox provides consulting and certification of users, operators and admins for qualification purposes.
The main product is the AIQ-Tool® software that automates and makes qualification independent from the customer CDS (chromatographic data system).
AnaTox provides software solutions for manufacturers, service providers and customers. Many of our customers are certified e.g., by the FDA.
AnaTox’s software solutions help customers to standardize instrument qualification according to USP <621> & <1058> and the EP regulations for GC and HPLC. The procedure(s) runs fully automatic and reduces the downtime of the instruments. A typical qualification lasts 3-4 hours.
The users are guided through all processes preventing any error or misuse. By adapting intricacies e.g., limits the procedures can be adjusted for each instrument. The qualifications are very reproducible and comparable for each instrument from each manufacturer.
Advantage: One protocol for all USP/EP used instruments
The benefit: It makes audits easy and reliable.
AnaTox solutions help clients leverage standardize global quality processes on a single technology platform. Direct hardware support by our own drivers ensures tracking of all setups and results, including meta-data, in a database.
Validation according to FDA regulations of the software ensures the customers that AnaTox is poised to assist clients in automating global requirements.
If delivered as a service: AnaTox delivers the AIQ-Tool software directly to the customer by its service provider.
The benefit: Low investment.
If delivered as in-house solution: AnaTox makes AIQ-Tool software available via certification and training.
The benefit: low running expenses and “pay per use” cost savings.
By registration at AnaTox notification of updates and training is provided. Whether how the software or services is used AnaTox provides full support by training or up-to-date updates of regulations. According to the FDA regulations each customer or service provider is trained and certified before starting the qualification of instruments. Training and re-certification are online available.
The benefit: Updates and re-certification at any time.