SpecLIMS – Laboratory Management

SpecLIMS comprehensive Laboratory Information and Management System delivers key features to automate daily laboratory processes and operations for optimal data-tracking, specifications conformity, data mining, planning, and workflows.

SpecLIMS – Laboratory Management2019-08-29T12:02:22+01:00

SpecLIMS optimizes and enhances quality control, administrative functions, budget control, workflow and data tracking support, data exchange, informatics, and specifications conformity.

This innovative software-based solution is available on-premise or in the cloud. It is exceptionally user-friendly and simple to implement and navigate; through integrated and performance-oriented testing instructions, along with sampling plans, analysis plans, work lists and progress checks, along with standardized approval options, SpecLIMS ensures optimal planning and workflows in your laboratory. Data access can be defined by application, field, function, report and many additional parameters.

SpecLIMS has been specifically designed to meet the requirements of formula and recipe-based food and beverage manufacturers. It is a global-friendly solution employed in multiple countries, in many languages.

Integrating the SpecLIMS quality management system provides the foundation for superior analytics and comprehensive traceability in compliance with regulatory requirements and best laboratory practices. It delivers integrated, high-performance test procedures and analysis plans, work lists and progress checks and standardized, automated approval options providing maximum efficiency.

SpecLIMS provides quality assurance and fulfills GLP, ISO 9000, 1400 & 17025, HACCP, GAMP, GMP and EN45001 requirements. This includes compliance with 21 CFR, Part 11 requirements for electronic records.

  • Informatics system designed for data management
  • Data mining for quality control
  • Administrative and budgeting capabilities
  • Workflow and authorization architecture
  • Data analysis for traceability in regulatory compliance best practices

SpecLIMS is a multifunctional modular set up and has many different standardized and independent units.

  • Many query options allow for efficient tracking of all registered data. SpecLIMS supports user-specific data samples and stores any personalized search patterns. The automated Audit trial ensures that all relevant original data and any changes are stored in the database
  • Data access can be defined by level, for example application level, or by function, field, reports and other parameters. The default function allows permissions to be easily customized according to which users have access to which data
  • SpecLIMS enables optimal data exchange with other applications, such as SpecPDM product development and recipe management, process control, ERP, logistics and financial management, and integrates with MS Office
  • With SpecLIMS your quality assurance will benefit from a tool which meets the requirements of GLP, ISO 9000, 14000 & 17025, HACCP, GAMP, GMP, EN45001. This includes compliance with 21 CFR Part 11 requirements for electronic records and electronic signatures
  • Intuitive multilingual user interface in German, English, French, Spanish and Italian
SpecLIMS

Master data management

  • Raw materials, semi-finished and finished goods specifications, including interface to Supplier’s Guide
  • Control of test equipment
  • Device interface to test equipment
  • Supplier and customer addresses, including contact persons
  • Document management
  • Workflows
  • User Management

Test plan

  • Test procedures, test reports, analysis criteria, units, methods and instruments, including individual limit values ​​and alarm values
  • Test frequencies (each time, at defined time intervals, daily, weekly, 2x annually, etc.)
  • Create new test plans from templates
  • Automatic generation of test plans from specifications
  • Individual test plans per supplier or customer
  • Cost

Sample application and information gathering

  • Test procedures, sample reports, analysis criteria, units, methods and instruments
  • Data collection with flexible work lists for fast and flexible grouping for data collection
  • Automatic sample order selection via barcode
  • Automatic and multi-level release
  • Result or batch validation
  • Batch traceability

Reporting

  • Standard reports and Certificates of Analysis
  • Barcode labels
  • Intuitive flexible report generator exportable data to MS-Excel and MS-Word
  • Laboratory journal
  • Statistics and graphical analysis
  • Cost analysis
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