DOQ Support in Tuttlingen

DOQ is not only a fully validated software, but also helps to minimize the validation effort for all other software systems in your company including ERP (e.g. Majesty), CAQ and machine connections while guaranteeing and complying with all regulatory standards - 21 CFR Part 11, ISO13485, MDR and 21 CFR Part 820 (GMP). The following measures guarantee a regulatory correct introduction of DOQ into the business environment.

  • Support in the preparation of the validation master plan (including classification scheme for software)
  • Drawing up the required procedural instructions for DOQ use
  • 21 CFR Part 11 Training of employees
  • Writing the supplier's audit report LA2 GmbH
  • IQ/OQ/PQ documents
  • DOQ 21 CFR Part 11 checklist
  • Preparation of the FDA application for the digital creation of documentation

The electronic device history records (eDHR) for each production order are generated in DOQ as PDF/A and stored in the database. For backup purposes they can be transferred to an existing DMS or archived with the DOQ module Long-term Archiving.

The DOQ Long-term Archiving module meets all requirements for a regulatory correct, digital long-term archive. All data to be archived (e.g. DHR) is automatically sent from DOQ to the long-term archive with a customer-specific encryption and managed there.

The installation and data management of DOQ can be realized both on own servers and as a cloud-based solution. A modern system architecture with programming technologies such as Java, JEE, HTML 5 and jQuery on an MS SQL database guarantee the future viability of DOQ. The browser-based application allows working with DOQ even across different locations. The well thought-out role/user concept can be configured according to individual company requirements to meet special workflow needs. Due to the free scalability of the system DOQ offers the possibility to grow with your company.

Our service team will not leave you out in the rain. No matter whether you decide on our service and maintenance package "Basic" or "Premium", should a problem arise, we are there for you. Annual release deliveries guarantee a contemporary further development of our software, taking into account user requirements. Each update is provided to our customers fully validated. In special cases we can also offer a 24/7 service.

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