Using the LIMS system has never been so intuitive and affordable! Evaluate the functionality and see that implementing a LIMS system does not have to be a big challenge for the company.
PharmaComplex is a modular LIMS system dedicated to the pharmaceutical industry, precisely reflecting the specificity of the work of all departments of the plant (QC, QA, R&D, production) and adapting to their needs. It saves time (including full automation of the current assessment of trends and the generation of extensive reports for the Annual Quality Review), improves the flow of information between departments (during the dismissal and certification procedure, or actions taken in connection with observed deviations or reported complaints), maintaining data security and integrity and meeting industry requirements and guidelines (GMP, GLP, ICH, FDA 21 CFR Part 11).
PharmaComplex - Easy to use. Low price. Scalable in every aspect.
PharmaComplex SYSTEM MODULES
Quality Control Module
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managing all aspects of laboratory work - samples, deadlines, tests, staff, documentation, etc.;
scheduling the work of analysts and equipment depending on availability;
management of methods, specifications, protocols, tests, samples, batches, batches from their creation to receipt of the final certificate of analysis (COA);
full control of sample circulation: testing planning, sample acceptance, conducting tests, entering and validating results, data analysis and certification;
managing procedures and methodologies in force in the laboratory and assigning them to the client service process;
current preview of the work schedule assigned to the selected laboratory (information about the need to collect samples for testing, conduct tests and enter results, confirm the entered data);
ability to use data entry templates defined in the system (form and certificate templates);
assessment of the obtained test results in terms of compliance with specifications and the occurrence of undesirable situations (OOS/OOL/OOT);
the ability to create your own analytical projects: you can select any fragment of data, various series, combine different series into one set and perform selected or all available analyzes for them, and view their results in the program interface or save them in the form of a report;
generating any summary and management reports;
the ability to automatically send e-mails notifying about the occurrence of a specific event, e.g. the need to collect samples, enter results, certificate approval, OOS/OOL/OOT, etc.;
access to individual system functionalities controlled by permissions, roles and groups to which Users are assigned;
an audit table that records the date, time and workstation of all User activities.
Stability Test Module
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management of the entire stability testing process: personnel, chambers, samples, deadlines, tests, analyses, documentation, etc.
scheduling of tests depending on the availability of staff and equipment;
monitoring the progress of ongoing research, alerting about exceedances and undesirable events;
easy modification and adaptation of the schedule to changing needs (adding or removing time points, parameters, etc.);
automatically performed statistical trend analysis, which is performed online after entering each result;
automatic statistical analysis of test results of all product series, as well as the possibility of combining data from many series and their joint analysis;
research can be conducted during product development as well as for final production batches;
advanced data modeling to accurately determine the shelf life of products in very short periods of time using the ASAP technique;
a report generator that allows you to create at any time a personalized report of performed or planned tests, schedule, chamber load, staff, equipment, sample monitoring, observed deviations, OOS/OOL/OOT alarm cards, as well as the time consumption of tests and their costs.
Environmental Monitoring Module
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effective management of defined collection points through visualization of production lines;
identifying sampling zones and sampling points for which environmental testing should be conducted;
creating test schedules for individual sampling points or personalized protocols covering different sampling points;
reminding about the need to collect samples and monitoring the collection status;
sample storage management;
individual or group entering and approval of test results;
automatic trend analysis online and evaluation of each result entered into the system using analysis methods adapted to the specific distribution of microbiological data (analysis with low variability of the analyzed data);
the ability to create your own analytical projects: you can select any fragment of data, various series, combine different series into one set and perform selected or all available analyzes for them, and view their results in the program interface or save them in the form of a report;
creating reports summarizing the collected data and listing all registered alarm situations.
Trend Analysis Module
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ability to analyze trends in data entered manually or imported from spreadsheets, databases and external systems, e.g. ERP systems, SAP, MS SQL Server, Oracle, Excel, etc.;
the ability to simultaneously monitor even thousands of parameters in a dashboard specially designed for this purpose;
trending data from any area (stability tests, environmental monitoring, finished product, API, packaging materials, semi-finished product, process parameters, etc.);
adaptive online data analysis algorithm which, depending on the specificity of the area (stability, microbiology, process parameters) and data distribution, selects and performs appropriate analyzes in real time;
the ability to create your own analytical projects: you can select any fragment of data, various series, combine different series into one set and perform selected or all available analyzes for them, and view their results in the program interface or save them in the form of a report;
configuring the alarm rule for unwanted events (OOS/OOL/OOT).
Process Parameters Module
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intuitive wizard for creating and managing forms for entering data in production;
flow of information between QC and production - certainty of using only approved materials (substances);
possibility of linking with the batch: exemption certificates, batches, other batch reports in order to identify which batches of semi-finished products and raw materials make up the batch of the final product;
batch genealogy enabling assessment of the impact of various components (materials) used to produce the final product on its test results;
indicators for monitoring the performance and workload of personnel, equipment and machines;
automatic statistical analysis adapted to the specificity of the collected data;
creating reports summarizing the collected data and summarizing recorded alarm situations.
Equipment Management Module
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planning, management and control of available equipment - repairs, maintenance, calibrations and control samples;
simple scheduling of activities;
quick verification of equipment status, test results and certificate preview, e.g. for audit purposes;
blocking against the use of uncalibrated measuring instruments;
automatic e-mail notifications about the need to perform specific actions;
assigning activities and responsibilities to staff;
generating reports summarizing the history of equipment.
APR/PQR module
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the APR/PQR module automates the process of preparing the product quality review;
the ability to integrate data from all areas and jointly analyze and create reports and summaries for the product quality review;
to generate a complete product review report, simply indicate the appropriate product item from the list, for which the System will find all data related to this item;
full control over the report being created - you can view the documents that will be included in the annual report and the analysis results at any time;
preparation of an annual review report limited to a few mouse clicks.
Event Management Module
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This Module is a universal solution enabling the registration and management of all requests/events applicable in a enterprise and their ongoing handling, among others in the following areas: change management, deviations, CAPA, complaints, review of returns, quality-related recalls and investigations, qualification status of equipment and utilities, review of post-approval obligations for new marketing authorizations and changes to marketing authorizations, review correctness of all product, process or equipment corrective actions, review of starting and packaging materials, etc.
The module provides Users with, among others:
access to cross-sectional information about registered, canceled and completed Applications and the status of individual Applications;
assigning tasks to individual Users;
automatic e-mail notification about the need to perform specific actions;
ability to filter by collected data (status, users, dates, etc.);
access to the full history of Applications, their modifications, etc.;
