INQAS
INQAS-LIMS is designed to meet the QA/QC and compliance requirements of FDA controlled and ISO 9000 manufacturers in the areas of Quality Control, Laboratory Management, Stability Study, ERP interfaces and Instrument interfaces.
English,
French,
German,
Italian,
Portuguese,
Spanish
Supported Technologies
AIX,
HP/UX,
Linux,
OS/400,
Solaris/Sun OS,
Windows XP/2000/NT
Web-Based (Browser)
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Pricing
Users (# of seats), Server, System, Module
25000 to 2000000
info@interpec.com
+1 (201) 5290611
Additional Product Information
Document Control ;INQAS assures that the last official specification and test method master documents are used in the analysis and evaluation stages. It keeps a full history and provides auditability of the official documents used. ; Sampling Plan ;INQAS provides cyclic sampling plans based on skip lots and/or elapsed time between lots tested. lt also provides user defined formulas and tables to calculate the sample size based on the number of containers or the batch/lot quantity. Sampling instructions are available to the sampler through on-line inquiries and sampling reports. INQAS offers the capability of customizing the printing of bar code labels.; Test Results ;Entry and Validation of quantitative, qualitative, and table-driven results are validated and verified against an acceptable range or code defined in the specification master document. The automatic validation process eliminates the possibility of human error in the comparison process. INQAS provides security options to prevent unauthorized personnel from entering results and to assure audit trails are maintained. ; Quality Assurance Certification ;INQAS verifies that all required samples have been taken, that all required tests have been entered and verified, and that all results meet the requirements of the official specification master document before allowing an audited approved disposition. lt certifies each batch/lot before releasing it to fulfill production orders or customer shipments reducing expansive material rejections and product recalls. ; Batch/Lot Management ;INQAS provides a series of tools to assist Quality Assurance in the management of batch/ lot information. INQAS displays test results trending and provides management summary overviews. It lists all ingredients used in the manufacturing of a batch/lot. lt compares and selects all certified batch/lots in inventory that match specific customer property requirements. INQAS calculates and charges to specific accounts the actual costs incurred in the certification of each batch/lot. ; Reports and Certificate of Analysis ;INQAS includes a flexible report writer ideally suited for printing user-defined and multilanguage certificates of analysis in addition to a wide range of standard reports. lt generates the certificates of analysis using either the manufacturing or the customer's specifications and may be displayed using a standard word processing software. The standards reports available in INQAS include the sampling worksheet, the sample status, batch/lot detail information, in-process exceptions, and others. ; Stability Management ;The stability management module provides full functionality for designing and performing stability programs to determine shelf life and potency degradation. lt can be implemented for production or research and development stability programs.; Stability Protocol Definition ;INQAS provides full functionality to define the protocol for the stability program. The number of stability study stations and their respective time intervals can be defined. For each stability station, the number of samples from each storage condition and the test methods for each sample can also be predetermined. ; Stability Program Studies ;INQAS provides a stability plan that allows the stability program coordinator to distribute the stability workload throughout the year and assures that the minimum number of batches are placed in the stability program. Batches specified by the stability plan are automatically sampled. Enough samples are selected of each of the specified storing environments to support the stability program study. When stability samples are due for analysis, INQAS automatically requests the samples to be retrieved from their storage condition and sent to their respective laboratories. lt also specifies the test methods to be used to analyze each sample. The testing protocol can be modified during the stability study. INQAS provides time-phased stability reports that comply with regulatory bodies such as the U.S. Food and Drug Administration and may be displayed using a standard word processing software. ; Stability Reports ;A look-ahead report anticipates the retrieval of stability samples from storage. It also serves as a sampling worklist. Printed labels for stored samples including storage environment, storage date, and pull date are available. ; INQAS Business Information Exchange ;INQAS exchanges information with the purchasing, inventory, accounts payable, material requirements planning (MRP), and production control applications. lt uses MRP to calculate laboratory equipment and personnel requirements. lt prioritizes laboratory samples based on production schedules. Inventory receipts trigger sampling worklists. Customer shipments are validated against customer quality specifications. Ingredients and intermediates traceability records are extracted from inventory transactions, reviewed, and included in the INQAS batch record. INQAS controls and synchronizes the quality status and the recertification and expiration dates of the inventory software application. ; Vendor Quality Performance Monitor ;The Vendor Quality Performance Monitor (VQM) retrieves information from the purchasing, receiving, and accounting applications and combines it with the INQAS quality information to perform vendor quality performance analysis. lt measures material delivery performance based on time of delivery, material quality, documentation accuracy and completeness, and supplier reaction time. lt adjusts the values of each measurement according to relative importance. VQM contains a vendor response log that supplements the vendor performance information. Vendor performance analysis results are displayed on- line and through reports. ; Instrument Connectivity ;INQAS offers a client/server application (LABLINK) that runs on the personal computer and provides to the analyst a graphical interface to the Laboratory Information Management Module. LABLINK communicates with instruments that have RS232 output or are directly controlled by computer systems. The PC/instrument communication is achieved through a user-friendly system designed for laboratory instrument interacting Special windows help the user build, test, and implement the interface protocol between the PC and the instrument. The Application Server inputs and controls the client/server programs. Test methods pending analysis are selected in the Application Server through the PC. Before downloading the master documents, calculation formulas, input forms and all additional required information, INQAS verifies that the analyst is authorized to perform the selected test methods. The analyst confirms in the Application Server that the instrument to be used is in calibration and obtains from the database any standard or reagent value required to perform the analysis. The PC reads all preselected data from the instrument and calculates the test method result. The analyst reviews the test method result. and updates the database. All required data is stored in the Application database and any additional desirable data may be stored in compact discs for future reference. ; Statistics and Graphics ;Data required to be statistically or graphically analyzed is selected in the Application Server through the graphical interface and downloaded directly to the PC application for display. ; Laboratory Resources Management ;INQAS gives laboratory managers full view of the requirements and availability of laboratory resources to adjust capacity and schedules. Budget planning figures can be used to obtain instrument and labor usage forecasts. Production planning information is integrated with the laboratory scheduling system to anticipate capacity requirements and to coordinate scheduling priority. INQAS assists the laboratory supervisor in balancing the workload and assigning the pending test methods to analysts or to bench areas. Costing, lead time, and utilization reports provide performance evaluations. ; Sample Management ;INQAS monitors and controls the sample progress throughout the conplete analysis cycle. lt tracks samples through the sampling, preparation, transport, receipt, testing, and certification steps. It makes accessible detailed information on sampling such as sampler, destination, receiver, analyst, certifier, due date, ID number, and date and time stamp. INQAS eliminates the need to maintain sample log books. ; Good Laboratory Practices Compliance ;INQAS monitors the compliance with Good Laboratory Practices (GLP). lt assures that the latest test procedures are used. lt controls instrument calibrations, reagents, and standards. lt assures that the analyst is authorized to conduct a specific method or operate a specific instrument. INQAS performs routine method calculations eliminating the need to verify calculated results. All required supporting data is kept and can be used to recalculate the test results. ; Standards, Reagents and Instrument Calibration ;When performing a test method that requires standards and/or reagents, INQAS verifies that they are approved for usage and are within expiration date. Instruments used in the method are also checked for calibration status. Standards, reagents, and calibration values can be imported automatically into the method calculation. ; Security ;All users must be registered in the Application Server and in the INQAS security function to use any part of the system. Users can be restricted to specific jobs, options within a job, and types of items, samples, specifications, and methods.; Auditability ;INQAS provides a complete history of the official master documents and the laboratory batch/lot control documents. All records contain the user ID and the processing date/time stamped.; On-line Documentation ;The entire User Guide is available on-line in the system. A help key allows easy access to panel and report descriptions, error message explanations, introduction to fonctions, glossary of terms used, and the table of contents.; Customization ;INQAS can be configured without programming. lt provides user definable menus, authorized options, date and time formats, tables, formulas, security, and databases. All screens and descriptions may be displayed in individual company terminology or national language.; Native Design ;INQAS design takes full advantage of the Application Server on which it runs. lt is developed according to strict development standards; Client/Server Architecture ;INQAS utilizes the strengths of the IBM AS/400 and of the Windows NT operating systems to deliver the best of both platforms.