Description

IDIS delivers multiple applications for Tablet Dissolution, Content Uniformity and Sample Processing applications for the Pharmaceutical, Food and Environmental analysis disciplines. Method and Data records are managed using Oracle and MySQL high end databases with ALS powerful multiple field query form which display records from searches.

IDIS controls over 130 different instruments using software drivers developed by ALS. This allows applications to be configured using HPLC CDS, UV Visible Spectrophotometers, XYZ Autosamplers, Diluter Dispensers and Spectrofluorimeter, Tablet Dissolution Baths, Pumps, pH and Conductivity Meters, Filters Stations etc.

IDIS is developed under stringent GAMP and ISO9001 environments and results are managed on stand-alone or networked data stations.

  • Unique open connectivity provides customised control of various instruments.
  • For dissolution testing, IDIS control Baths from Agilent, Caleva, Copley, Distek, Electrolab, Erweka, Hanson, Pharmatest, Logan, Sotax and Varian (Vankel).
  • Spectrophotometer drivers for ALS, Agilent, Beckman, Biochrom, Cecil, Jena, Perkin Elmer, PGI, Shimadzu and Thermo (Unicam).
  • HPLC drivers from Agilent and Waters with Generic HPLC Driver for other HPLC systems, Shimadzu for example.
  • Pumps: Peristaltic, Syringe and Metering Pumps.
  • Valves for automating sampling and Media Change.
  • Fixed wavelength or full spectra acquisition.
  • Full sample analysis with plotting of profile in real time.
  • View live real-time results on networked workstation in real time.
  • Real time background absorption correction for excipients.
  • Multi-component analysis with unique Chemometrics for turbidity samples. No need to use other software packages for calculations. Post edit results to save re-running experiments.
  • Measurement of Blank, multiple standards for standard check, System Suitability, Pre and Post run measurement and calibration curve.
  • Group samples with different wavelengths, media volume and media type for method development or comparison against competitor products.
  • Automating pH media change with unique functionality for measurement of pH in Vessels.
  • Run multiple baths on one spectrophotometer and physically up to 4 baths on one PC.

Networking

IDIS records are stored on local or network database using multiple fields to store and find records. Data is cached to the IDIS database as it is acquired thus providing access to data acquired in the event of power failure.

  • Considerable time saving by centralised administrative tasks.
  • Results stored centrally for secure backup,
  • Intelligent searching for method and data records using multiple filtering such as project Groups, user names, date, project names, date and year etc.
  • Results can be accessed from any remote workstation or client anywhere in the world
  • Remote configuration and reporting.
  • Fault tolerant database stores local workstation analysis data in case of server disconnection or failure. There is no data is lost if the server is disconnected.

User Interface

Applications in IDIS are built using intuitive Solution Path Technology where methods are constructed by linking icons representing drivers to each other to create methods. This approach to creating methods makes it simple, intuitive and reduces the number of dialogues for method details. The links show graphically how instruments are used for the application.

Once the IDIS methods are designed, the graphical interface can be copied into word, Excel, etc., to aid report writing for SOP’s, and on the application.

Data Management

Quality results from analysis are very important. These represent many days, months and man years of work time so organising this precious commodity so that it is secured, can be easily backed up and restored; and specific results easily found and loaded for review and printing is very important.

IDIS applications use Oracle and MySQL databases for centralised data storage and networking. This provides sound data integrity and reliability especially required for network solutions. Multiple fields make it easy to find the results from tests with optional simple SQL querying filters to enhancing searches.

int7

Reporting

int7

Regulatory compliance

This regulation from FDA stipulates how software and computerised systems should meet requirements for electronic records and signatures.IDIS applications provide centralised administered access right security configuration and global settings.

Our implementation of 21 cfr part is unprecedented, fully versatile, seamless and easy to use.

  • User logon on, method creation and analysis performed with strict compliance to FDA 21 CFR Part 11
  • User Queryable Audit Trail
  • Reviewers auditing
  • Administration management allows configuration of Users with Groups or individual access rights with simplicity.
  • 5 definable signature levels provide for technical and managerial signatures with Signature Tracking.
  • Unique features include Log off Times by level, Password Expiry editable prompts.

Specification

  • Analysis Configuration
 Single, Networking Multi-user, Multiple Application Support, Manual Data Input.
  • Analysis Type
 UV-Visible, Conductivity, Fluorescence, HPLC (fully automated).
  •  Instrument Configuration
 Closed Loop, Switching Valve Closed or Open Loop, pH Change, On Line Collection and Sample Preparation. Content Uniformity.t
  •  Analysis Type
 USP 1&2, 3, USP4, USP 7, Transdermal Diffusion Cell.
  •  Calculation Types
 Normal, Multicomponent Analysis (MCA), (Single λ per Component, Least Squares and TFA), MCA Discrete, 2 λ, 3 λ Correction.
  • Statistical Types
Mean, SD, SD Pop, Variance, Variance Pop, C of V (RSD), Minimum, Maximum, Delta (Difference).
  • No. Of Components
 >5 (no limit).
  • No. of Data Points per Vessel
 >100,000 (no limit).
  • No. of Vessels
 Typically 6, 8, 12 o4 14, dependent on Bath.
  • Maximum Test Time
 >999 Hrs (no limit).
  • Graph Type
% Dissolve, Concentration, Intensity (dynamically selectable), Temperature, Speed, pH, Calibration Curve, and Spectrum.
  • Data Input
 Continuous Online, Manual, Deferred Data Collection, From File.
  • Standard Data Input
 Intensity, A¦, Continuous Monitoring, External Calibration (>10 standards, no limit)
  • Specification
 User specified >20 point, ><, Range. USP Multiple Q Value Check, Automatic Fail Repeat Checking.USP Acceptance Specification and PVT Test. Automated results tracking and linking results.
  • Report
 Dynamically Organised with Windows Print Preview.
  • Standard Data Formats
 Windows Clipboard Select and Copy, ASCII Data (Excel compatible).

 

Data Output

  • Data Exchange
 User Defined Text Configurable Data Export, Unique File reference, Centralised for multiple workstations. For LIMS or Electronic Notebook.

 

Post Run Manipulation

  • Post Edit
 Editing of Input Data (password limited access).
  •  Reprocessing
 Chemstation and Empower CDS.
  • Managing
Replacing data records in Specification Results table.
  • Re-measurement
 Chemstation and Empower CDS.

 

Data Management

  • File Type
 Networking, Relational Database, Oracle and MySQL databases.
  • File Search
SQL Querying, By Selection or Ad Hoc.
  • File Search Criteria
 Product, Date, Time, Operator, Batch, Station, Detector
  • No of Users
 >100 (no limit).
  • Security Maintenance
 Administrator Defined Rights; Name, Password and Group.
  • Data Backup
 Database Merge, Batch Archiving and Restoration, Audit Trail Search and Filter, Export to Text or Excel.

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