Quality Assurance

Customers which work in a regulated environment which usually applies to the pharmaceutical industry and medical laboratories, must implement a validated software.  If the products are also exported to the USA, then the systems must be implemented according to FDA 21 CFR Part 11.  In the USA, all laboratories which analyse food stuffs, must undertake an FDA audit. 

Many laboratories with an order oriented focus, strive for accreditation according to ISO 17025 which must be supported by the system. 

AJB fulfills these requirements through comprehensive measures taken in the area of product development and the organisation supported on the customer side.

• Quality Management System after ISO 9001

As a supplier of quality assurance systems, of course AJB works after DIN ISO 9001. Through regular audits by the certifier, it is ensure that quality assurance systems are realised by all staff.

• Qualification of the products

The products of AJB, i.e. blomesystem^® Designer, blomesystem^® Report Generator and DCM are developed and permanently improved in a documented environment.  Blomesystem^® products go through a time consuming qualification to ensure that the customer applications are validatable.

• Validation of the standard applications

The design and the implementation of standard applications is of a high priority during quality assurance because these systems form the foundation for the customised customer solutions. 

• Services in the areas of IQ, OQ and PQ

The delivered standard systems either fulfill completely or to the most part the requirements of the customer.  If changes or developments of a standard application are required within the scope of the project, then experienced specialists are available to undertake the validation.