ISO 17025 and FDA Compliant LIMS-Software for the Laboratory
Whether acquiring and managing samples in the foodstuffs-industry, planning, developing, and selecting methods and experiments in the pharmaceuticals business or consistently analysing and monitoring pool parameters during galvanization operations: managing the sheer quantity of information and abiding by strict data security regulations are challenges that the research and in-house laboratories of virtually all industries face.
LIMS – Laboratory Information Management System
In order to support laboratories throughout the management of their equipment and information, guidelines such as GLP (Good Laboratory Practice), the FDA’s 21 CFR Part 11 or GAMP (Good Automated Manufacturing Practice) were developed. These generally require adherence to standards such as ISO 9001 and especially ISO 17025 or ISO 15189. Maintaining these complex systems and their associated tools, however, is difficult with pen and paper or spreadsheet solutions alone. This is where CAQ.Net® comes into play. It facilitates the targeted implementation of individual software modules in order to create a scalable, future-proof, and fully integrated laboratory information management system (LIMS).
Comprehensive Sample Management
The software consistently supports you throughout all analyses, inspections, and examinations in the laboratory and lays the groundwork for comprehensive sample management. Whether preparing, gathering, and distributing samples or performing statistical analyses and creating control charts: CAQ.Net®’s Compact.Net module provides you with all the tools you require for data acquisition, preparation, and evaluation in the laboratory. In order to ensure data security and the various traceability requirements, the software also contains tools for batch-tracking and analysis specification. Compact.Net furthermore supports you throughout the management of deviating analysis results such as Out-of-Specification (OOS) Results, Out-of-Expectation (OOE) Results or Out of Trend (OOT) Results.
The integrated certificate generator in Compact.Net allows you to automatically generate certificates directly after an inspection has been completed. For this purpose, the software gathers all the batch information of relevant inspections that is contained in the database and generates a tailor-made certificate accordingly. This certificate may also contain individual raw material certificates such as Certificates of Analysis (CoA). Additional validation inspections after the laboratory analysis, fully automated label printing or the automatic multi-language creation of batch-related certificates conclude the functionalities of the software.
CAQ.Net®, however, offers a lot more than the basic LIMS-functions required in the laboratory. The system doesn’t just give you a clear overview regarding all laboratory and sample related aspects, but also brings together all important information of the company. It achieves the necessary level of data transparency by bringing together and interconnecting all aspects of your management system. This means that all additional modules for supplier management, audit management, complaint management, document management, task management etc. can be linked and all data used for cross-modular evaluations.
The interconnection of the modules is particularly important with regard to supplier management. In order to be able to practice comprehensive supplier management, it is necessary that you can combine and cross-analyze all available information. In CAQ.Net®, all data, audits, complaints, risk analyses, or incoming goods inspections that are gathered via the applicable modules are included in one knowledge-database and can be accessed directly via the central supplier management module SRM.Net. This allows you to systematically and effectively manage all supplier relationships of your laboratory and company.
Manage and Calibrate Laboratory Equipment
As the reliability of information is determined right at the point of its initial collection, perfectly functioning equipment is essential for the functioning of the laboratory. Gauge and maintenance management is applied in order to ensure that the employed devices are always correctly calibrated and in sound working order. It furthermore organises the acquisition, application, and maintenance of all measuring equipment. Within CAQ.Net® these aspects are covered by the modules PMM.Net and PMS.Net. Apart from providing real-time monitoring and documentation of the state of equipment as well as its location of use and calibration status, these modules ensure that only devices which are available and in sound working order are implemented in measuring processes – thus eliminating the possibility that faulty or unsuitable equipment is used.
The Qualify.Net training management module supports you during the planning, execution, and documentation of all training-related matters in your laboratory. Apart from assisting during the documentation of all existing qualifications and planning of future employee trainings, it is primarily the consistent target/actual comparison regarding required and available qualifications that provides a significant reduction of the training-related workload. Just a few clicks allow you to fulfil key documentation duties and create an expressive and easily maintainable qualification and training database. The qualification matrix in the software furthermore allows you to, for instance, precisely trace which employee requires training in which area and at what point in time said training is due. This means you can consistently monitor and document any type of training and qualification – regardless of whether you are dealing with safety trainings, language tuitions, technical schoolings, or any other type of training.
Within today’s information technology there are few aspects that are as important as the effective and efficient interaction between different systems. Our interface module Connect.Net is designed to connect your management system with other systems just like a universal adapter, and ensure mutual and streamlined exchange of data. Thanks to Connect.Net, our entire CAQ.Net® software family can today seamlessly merge with a multitude of IT-systems such as ERP, MES, CRM, PLM etc.
Electronic Data Transfer
The automatic transmission of inspection data in CAQ.Net® facilitates the direct exchange of information between your laboratory equipment and your sample management. The interface learns the protocol you define, remembers defaults, and automatically acquires the applicable inspection data and places it in the database. The information is then allocated accordingly and can be used as sample data when required.
Audit-Trail in Place
The change control used in CAQ.Net® means that changes made to records, products, or systems are consistently and comprehensively documented in the audit-trail. A separate structure is thereby used in order to record the date/time, username and workstation when changes are made. This allows you to precisely identify, when who made what changes where. Hence, the fulfilment of all relevant documentation duties takes place in the background, and, at the touch of button, you can immediately receive all e.g. audit-relevant change information as stipulated by applicable standards and regulations.
Total Document Control
An efficient and effective document management system is vital in order to successfully tackle the documentation duties of regulating standards. Create, maintain, control, and archive all your documents with just one program. The software QBD.Net can be fully embedded in your existing MS Office environment, allowing you to continue to work with the programs you are familiar with and use QBD.Net to control all document monitoring and maintenance processes in your laboratory and company. Amongst a host of other functions, QBD.Net includes sophisticated escalation management, project tracking, document access control, and facilitates a 100 % paper-free and 21 CFR Part 11-compliant documentation.
Application in Regulated Environments
We have extensive experience regarding the qualification and validation of our system in FDA/GxP-regulated areas. The resulting target/actual comparison between CAQ.Net® and the most current requirements or pertinent standards means that our customers are always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant working.
A Holistic Management Solution
Successful information management in the laboratory requires an all-inclusive management solution that covers all facets from sample management via LIMS to process visualization, document management, and device management and ensures consistent compliance and traceability. This solution must also incorporate all aspects of quality management and facilitate the adherence to valid standards and guidelines. This solution is CAQ.Net®: the one-stop management-solution for your laboratory.
- Designed for application in regulatory environments (ISO 17025, ISO 15189, GLP, HACCP, FDA 21 CFR Part 11)
- Order management, sampling, inspection, and analysis functions
- Easily connect, manage, and calibrate laboratory equipment and analysis devices
- Make your laboratory paper-free with 21 CFR Part 11 compliant documents
- Seamless change control with AuditTrail.Net
- Highly competent partners for validating your software solution
- And much more