Max Application has been working for long time with many pharmaceutical companies, realizing that an accurate and complete adverse events data management is the key to reduce the risk of safety problems.

We developed SafetyDrugs web-based system: a Pharmacovigilance software, powered by Oracle Database, designed to ensure compliance with regulatory requirements, from clinical development to post-marketing surveillance.

Furthermore, Max Application created a suitable and complete documentation set that assists your company in the entire process of Pharmacovigilance System Validation.

The project has been developed with a company leader in computerized system validations and GxP compliance.

Most of the systems on the market are complex and expensive, suitable only for big pharmaceutical companies, our product is suitable for small and medium biopharmas too, because of its ease in system validation process, installation and use.

Because of Max Application attention to small and medium companies needs, SafetyDrugs pharmacovigilance system can be provided with Validation Kit, a package of services and technical documents that permits a fast and inexpensive start of your Computerized System, including the process of validation.

In addition, Max Application offers SafetyDrugs in SaaS (Software as a Service) modality. Your company will be charged only a periodic fee for the sole use of the software and Max Application will supply:

• hardware and software infrastructure (server, operating system, software etc.)
• security and reliability of your data
• antivirus, firewalling, service redundancy, electric backup etc.
• daily data backup.

So your company has nothing to worry about: your data will be surely available 24/7.

In particular, the system has been assessed for being in compliance with the following regulatory rules:

• Directive 2001/83/EC requirements
• EMEA/H/20665/04/Final requirements for processing of safety messages and individual case safety reports
• 21 CFR Part 11 and ICH E6 requirements related to validation process and to the associated documentation and general features of System Security
• ICH Topic E2B and Topic M2 requirements related to the type of data that a Computer System used in Drug Safety Unit must manage and related electronic transmission.
• ICH Topic E2C requirements related to the extraction of the ADR information that a Computer System used in Drug Safety Unit must assure.

Thanks to our methods and focus on costumer care, our design, development and assistance system has been certified by ITALCERT, one of the most important and qualified certification organizations.