EffiChem 5.0
Cloud

Runs of EffiChem or third-party architecture
Fast implementation based on a proven configuration (max. 30 days)
Lower investment and implementation cost
EffiChem 5.0 Cloud

Characteristics and functions

A pre-configured solution in the cloud, based on EffiChem best practices. All-in-one: LIMS, QMS, DMS, and Statistical Data Evaluation.

General
  • MS SQL database
  • Highly configurable modules, workflows, roles and user privileges
  • Full-text search in (non-proprietary) documents and records
  • Filtering
  • Searching the full database using SQL queries
  • Message center, email notifications, task assignment, automatic reminders, and task escalation, if not complete
  • Unlimited configurable print reports combining multiple languages in the same report
Security, data integrity and traceability
  • In compliance with GAMP 5, 21 CFR Part 11, and Annex 11 to EU GMP
  • In compliance with ISO 17025, with a focus on art. 7.11
  • Features: Audit trail, history of records, electronic records and electronic signatures, including sign-off history
LIMS: Laboratory Information and Management System
  • Samples and results
  • Specifications, including limits and other acceptance criteria
  • Stability studies
  • Environmental monitoring and utility monitoring
  • Out of specification (OOS) and Out of Trend (OOT) results
  • Methods
  • Equipment/Instrument calibration
  • Equipment and ERP connection (coming soon)
  • Reference standards/materials
  • Columns
  • Chemicals
  • Material items
  • Solutions
QMS: Quality Management System
  • Deviations
  • Change control
  • Audits and audit observations
  • CAPA management (corrective and preventive actions)
  • Complaints
  • Risk analysis and risk management
  • Vendor qualification
DMS and LMS: Document Management System a Learning Management System

Controlled documents

  • Documents
  • Meta-data
  • Multiple configurable workflows
  • Version control (working, approved, and released documents)
  • Controlled printing

Training:

  • Training tests
  • Test questions
  • Test score/overview per document, per user, or per user-group
  • Email notifications, test reminders, task assignment, task/reminder escalation over time or management layer

Training monitoring:

  • Completed tests
  • Incomplete tests
  • Test overview and reporting
Statistical Data Evaluation – Method validation, uncertainties, control charts, calibrations, inter-laboratory comparison
  • Method validation
  • Uncertainty estimation
  • Control charts
  • Calibration
  • Inter-laboratory comparison

Trusted by

https://www.effichem.com/wp-content/uploads/2021/05/vuos_logo.png
https://www.effichem.com/wp-content/uploads/2021/05/Logo_Veolia_Water.svg.png
https://www.effichem.com/wp-content/uploads/2021/05/Chmu_uvod.png
https://www.effichem.com/wp-content/uploads/2021/05/1280px-ArcelorMittal.png
https://www.effichem.com/wp-content/uploads/2021/05/ORLEN_Unipetrol-03..png
https://www.effichem.com/wp-content/uploads/2021/05/stažený-soubor-2-1-1.png
https://www.effichem.com/wp-content/uploads/2021/03/cez.png
https://www.effichem.com/wp-content/uploads/2021/05/stažený-soubor-3-1-1.png
https://www.effichem.com/wp-content/uploads/2021/03/unilever.png
https://www.effichem.com/wp-content/uploads/2021/03/cocacola-1.png
https://www.effichem.com/wp-content/uploads/2021/03/nestle-1.png
https://www.effichem.com/wp-content/uploads/2021/05/Logo_Takeda.svg.png

View all case studies.

Examples EffiChem 5.0 Cloud

https://www.effichem.com/wp-content/uploads/2021/05/2__Vzorky_a_výsledky.png

Samples module

Samples and Results are the most commonly used LIMS modules, and enable automatic evaluation of results against Specification. The Specification can be numeric, e.g. ≥98.0% and ≤ 102.0%, or text: White Powder, Pass/Fail, Complies with the reference IR spectrum, etc. Samples in the module can be managed according to a configurable workflow like a QC workflow, ISO accreditation workflow, R&D, or others.

https://www.effichem.com/wp-content/uploads/2021/05/3__Odchylky_detail.png

Deviations module

The deviation record shows the automatically assigned identification number and descriptive data like the deviation name, detection date, initiator, coordinator, deviation description, deviation classification, responsible person, root cause, CAPA action, customer notification, conclusion, and approval.

https://www.effichem.com/wp-content/uploads/2021/05/3__Postupy_-_výběr_validace.png

Methods: selection of the validation parameter to be evaluated

The drop down menu first lets you choose between full validation, exploratory validation, etc., then from the list of parameters to be validated, (Repeatability, Accuracy, Linearity, etc.). In the last step, you can choose from the list of algorithms that can be applied (Level by level from multiple measurements, or from parallel measurements).

https://www.effichem.com/wp-content/uploads/2021/05/3__Vzorky_a_výsledky_detail.jpg

Sample and Results detail

The sample detail shows descriptive data like the sample name, the batch number, receipt date, storage conditions, customer, etc. The Results table gives a list of parameters to be tested, corresponding units, required specification, the measured value and reported values, evaluation against the specification, the required and the calculated RSD, recorded by, checked by, and other configurable data fields.

https://www.effichem.com/wp-content/uploads/2021/05/4.-Linearita-graf.png

Linearity evaluation

An example of graphical evaluation of Linearity in the method validation module, showing the relationship between the concentration and the measured values. For a more detailed evaluation, a plot of residuals or supporting statistics can be used.

https://www.effichem.com/wp-content/uploads/2021/05/5.-Opakovatelnost-graf.png

Graphical evaluation of repeatability

An example of the graphical evaluation of repeatability in the method validation module, showing the concentration levels (x-axis) plotted against the difference between the measurement and the average measured values at the given concentration level (y-axis). This graph shows the method variability/repeatability.

https://www.effichem.com/wp-content/uploads/2021/05/1.-Plocha-1.png

Dashboard

The desktop is a cross-road from which individual functional modules can be started, including Samples and Results, Controlled documents, Equipment, Reference Materials, Deviations, Changes, CAPA, Statistical data evaluation, etc. The desktop can be individually configured per user for maximum efficiency.