Regulated Environment

MAQSIMA LAB+ | The LIMS – safety and regulation compliance for a regulated laboratory process


With a modern LIMS the diverse work and documentation obligations in a laboratory can be performed efficiently and legally compliant. This saves time, streamlines processes and provides legal security. This especially applies to processes in laboratories with high regulatory requirements – for example GMP/GLP regulations or FDA guidelines.

On a highest technological level, MAQSIMA LAB+ combines the convenience and user- friendliness of classic Office programs with the know-how and process-orientation of day-to-day laboratory life. All this, with the guarantee of meeting the strict provisions of GLP/GMP, ISO 9001 and ISO 17025. This combination results in a high level of acceptance from employees, customers and vendors and contributes to efficient working in laboratories.

MAQSIMA LAB+ – the compliant and qualified LIMS standard

Standard modules in the basic system and user-oriented additional modules as well as customization to the requirements of individual work stations make MAQSIMA LAB+ extremely flexible. Access protection and complex rights assignment secures the system and the data and at the same time acts as a basis for seamless communication – also with customers and suppliers.

The experts of MAQSIMA ensure compliance with the guidelines already in the conception and implementation phase of MAQSIMA LAB+. In close collaboration with customers, the relevant modules and the applicable guidelines are defined and taken into account.

On this basis, an individual solution for the customer is created from the modular LIMS. From the outset, a comprehensive risk analysis is performed and laboratory employees are trained in the new LIMS early on. Through a continuous validation process in this introduction phase, challenges can by identified and overcome early on.

Numerous features of MAQSIMA LAB+ ensure compliance with the regulatory provisions. LIMS has a detailed user administration and comprehensive rights management system with which access rights can be specified down to the last detail. Automatic logout after a predetermined period also increases security against tampering.

All data and their history are recorded in an extensive audit trail. The audit trail is write-protected and allows for checking of exact assignments of objects, actions and persons. In addition, a data backup concept – for example data storage in a normalized data model – ensures highest data availability and the option of data migration.

MAQSIMA LAB+ as a qualified and compliant LIMS is the basis for a cost-efficient validation of laboratories for its customers. In addition, MAQSIMA also supports customers in these validation processes.

The modular system of MAQSIMA LAB+ ensures an optimal configuration for all options.

From the overall diversity of the modules, the following modules are especially interesting for compliant processing in laboratories: