LAB+ | The LIMS basic modules
basic system
A modern laboratory information management system (LIMS) maps all processes in a laboratory efficiently and clearly.
A key feature of a successful LIMS is
hence the accuracy with which the modules
to the daily requirements of the individual laboratory
can be adjusted.
Three important factors speak for MAQSIMA LAB+:
factor intelligibility: MAQSIMA LAB+ forms
the processes in the laboratories realistically
Settling in works quickly and smoothly.
factor Costs: The modular structure allows the scope of services to be precisely adapted to what is required in the respective laboratory.
factor usability: The operation of the individual modules is intuitive, many modules are based on well-known office programs and can therefore be quickly integrated into everyday laboratory work.
 Chargenverwaltung |
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 Berichtsgenerator |
 Rechteverwaltung |
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 Stammdaten |
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 Stabilitätsprüfung |
 Spezielle Prüfmethoden |
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 Freigabe Workflows |
 Probenverwaltung |
 Detaillierter Audit Trail |
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Special test methods
Especially in laboratories in a regulated environment, tests according to the specifications of the European Pharmacopoeia (Ph.Eur.) are indispensable. The Ph.Eur. Regulated tests often have to be carried out in a multi-stage process and cannot simply be expressed as a result.
Common tests are, for example, to demonstrate dissolution
(with and without Q), content uniformity (Ph.Eur. 2.9.6), mass variation
(Ph.Eur. 2.9.40), the impurities and contaminations or the linear
Regression required. Typically the result is a table with rows
and columns to map.
Precisely coordinated program functionalities:
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Illustration of the requirements of the Ph.Eur. within a check on process plan types
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each process plan type represents a specific testing method
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direct evaluations using statistical characteristics
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several steps can be presented in one test with one result (e.g. loss on drying)
stability check
Ongoing stability testing is one of the standard tasks in pharmaceutical laboratories. The corresponding module in MAQSIMA LAB+ offers the software-side solution for the planning, management and execution of stability tests. Thanks to secure access protection and comprehensive audit trail functions, the module meets the strict GMP and FDA guidelines.
The module thus ensures an efficient testing and documentation. It is important that appointments can be easily identified and tracked and that comprehensive planning of resources is made possible.
With the module: LAB+ | Stability testing - precisely tuned:
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Clear structure of test orders, storage, test schemes and deadlines
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quick definition of regularly used time and test schemes
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clear definition of responsibilities
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flexible customization options within the runtime
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fully integrated sample stock management
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Calculation of required samples and inventory control
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far-reaching concepts for measurement data acquisition
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Signaling of tolerance deviations
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flexible data evaluation
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Convenient creation of stability reports (also during runtime)
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Barcode-controlled outsourcing and posting of stability samples
LIMS requirements:
Evaluation and calculation of durability according to ICH Q1A (R2) and Q1E
Trend evaluation of release parameters (batch-dependent over a defined range)
