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Trend Analysis

System generates data trending reports and graphics at the click of a button with various filters on samples and test parameters, trend graphs in OasisLIMS display target values, warning levels, and out-of-specification limits. For process industry, OasisLIMS provides on-line trending capabilities that allow real-time updates of production process on active dashboard so that you can evaluate current processes stage that captures and generates alerts on the event of out of trend limits to help identify production issues long before occurance of any failure.

  • • Trend analysis provides graphical and tabular representation of resultant data of different batches to study the behavioral trend of a product over a period of time.
  • • It generates a comprehensive report as per the user's choice of parameters.
  • • Printing report gives a comparative analysis of batches on user-defined parameters along with the specification details in a standard spreadsheet format and a graph as well with warning limits and resultant data points.
  • • Built in functions to export report in spread sheet to further work on data.

Trend analysis data can be used to evaluate vendor to monitor supplies received over a period for critical praramters LOD, Moisture and Assay/Potency.

Trending data produces a comparative analysis of batches on user defined parameters along with the specification details in a standard spread sheet like format.

In addition, OasisLIMS also includes Statistic Quality Control (SQC) tools functions that generates process capability information with an option for extrapolation of trending data along with mean, median, max, min, the graph can incorporate linear line / logarithmic curves.

Vendor Rating / Qualification

Provision for registering approved vendors and suppliers for various materials, their approval details with date and re-certification dates. System generates comprehensive evautaion report on vendor rating on the basis of sampling/anaytical data available in the system.

The report comprises of various aspects of vendor supplies over a time including sample conditions, sample results, sample disposition summaries.

This module shall helps users in selection of vendors for approvals based on analytical data and sample data history.

Integrated Stability Studies

Oasis Integrated stability module is a powerful feature-rich module that manages the entire stability testing process, it is a comprehensive solution and is compliant with current regulatory guidelines as per FDA. Stability module efficiently handles all types of stability studies as follows:

  • • Accelerated
  • • Long term
  • • Intermediate

The system ensures study specific to the protocol including pull schedules, experiment conditions, tests, cycles and test specifications. Provision is available for user to load the batches associated with that study and samples are executed on the basis study protocol.

"Under integrated set-up with LIMS, the initial condition data/results for routine production batch are automatically fetched on summariesfrom sample management module."

A set of standard reports are delivered with the system for reporting of the stability protocol and its associated results. There is a provision to keep track of stocks including consumption records of stability samples. Option is provided to print stability sample bin card. Graphs of stability data have facility for plotting data.

Optionally, the system is also capable of producing projected shelf life trend analysis.

Alerts and reminders screen includes pending for withdrawal, study etc.

Oasis also has Stability software that can be used as a standalone system or as an integrated system complementing LIMS, and other systems such as ERP/MES etc.

Stability management system improves efficiency, reduces risks and provides a significant time savings.

Stability studies management functions include - Stability Protocol, Stability Bath loading, Stability Scheduling Pulls, Stability Login, Stability Readings Observations, Stability Schedule Printing, Stability Work Sheet, Stability Certificate of Analysis (COA), Stability Labels Stability Status, Samples pending for Stability login, Stability Protocol Sheet, Stability Graphs.

Reference / Working Standards Management

Registration of reference and working standards in the system that are used in lab for processing of various samples.

Efficient management of reference standards / working standards, procurement details, source, batch/lot no., assay/potency, LOD, manufacturing/expiry date, stadarization and next re-standardization dues etc.

Preparation of vials / bottles with date of prepration, valid upto date, unique identity number to track consumption and usage. Issuance details against individual sample analysis consumption, quanitity tracking at vial level with on-screen balances.

Reports on reference/working standard master, receipts, issuance log books with vial trace-ability etc.

Effective management of standrads that are due for destruction with report and on-screen alerts.

Equipment Calibration and Maintenance

Ability to track usage, calibration and maintenance records of instruments used in laboratory.

Keeping routine equipment calibration and maintenance records is a general requirement and standard practice of any quality control laboratory. Various instruments/equipments that are used in lab to help support testing of samples and are required to calibrated at regular intervals for their accuracy and consistent performance with respect to prescribed specifications and guidelines by the supplier. LIMS provides the facility to enable user to keep track of various equipments in the lab with their calibration and maintenance records.

LIMS provides integrated functions, which allow users to register equipments with complete details name, model, make, service resords, calibration/maintenence frequency. The module also enables users to schedule calibration, analyse/inspect instruments, record results in order to monitor the performance.

Assocation of equipment type ie. HPLC, GC, Balance helps in selecting the particular category of equipment efficiently during generation of various reports.

LIMS also keeps track of instrument history maintenance records with breakdow and service details.

Planner for the AMC, calibration of instrument / equipment is provided. This in turn gives the notifications / alert / reminder for the same on dues.

Equipment management major functions includes registration of equipment, calibration tests and limits for accuracy/precision, scheduling and recording of calibration events, AMC tracking and maintenence records.

Maintenance of instruments log books under LIMS integration mode.

Chemicals / Reagents Management

OasisLIMS provides a comprehensive module to maintain inventory and control of chemicals/glassware used in lab, there is a facility to track stock receipt and consumption of chemicals, a detailed reporting systems is available to generate useful reports.

Chemicals, reagents, glassware etc. can be entered with code, name, respective grades and unit of measurements.

On receipt of chemicals, reagents etc. there is a provision for login / registration of the same in stocks with vital information batch/lot, manufacturing/expiry dates, containers/quantities etc.. Provision is also avialable for recording issues of chemicals, reagents with requisition reference for direct consumption / or further prepration of solutions utilized in various activities of lab, can be recorded.

Stock positions of chemicals, reagents, glassware etc. can be drawn at any point of time from set of reports.

Stock statements, registers for chemicals, reagents can also be generated in different on different parameters with available quantities. Provision for destruction of leftover, un-utilized chemicals, reagents at a particular date.

Maintenance of chemicals log books under LIMS integration mode.

Control, Reserve Samples Management

OasisLIMS control / reserve samples management module provides the facility to efficiently control storage and handling of reserve samples that includes pack types, quantity, relevant batch details and compartment/box storage location for tracking.

Under LIMS integration mode, the relavant data is carried for a specific lot registed in sample management module with receipt confimations. Additionl details, such as, storage in compartment/location, pack sizes, quanities and descruction date provided with the option for routine visual obervation requirement.

Provision for requistion for withdrawal of control/reserve sample for testing/visual observation, and issuance records.

Provision for regular checks and reviews of control samples at pre-defined interval and test parameters for compliance.

It generates various registers and reports on maintenance of control/ reserve samples, compartment, pack style masters, inward, withdrawal registers, Destruction Registers, visual inspection sheet, material bin card, due for inspection and destruction.

Columns Management

LIMS column management module enables users to maintain detailed record of columns used and keep track of their performance. Set of useful reports is available including column master, issue, log book, usage record and destruction record.

Columns Management module allows registration of columns with important infromation like dimention, category, date of receipt/purchase, column ID/serial no, manufacturer/vendor etc.

Colume issuance records, column validation on specific test parameters for suitability along with details like mobile phase, flow, wl, vol etc., in addition, seperate function for column regenration. Column validation report, detailed column usage records in various samples analysis with flow, no. of injections, date/time, column wash date/time, column logs etc.

Maintenance of column destruction records with due for destruction alerts. Product wise, column wise number of injections record on the report. Maintenance of columns log books under LIMS integration mode.

Microbiology / Media Management

LIMS micro / media management module efficiently manages culture used for micro anaysis and environment monitoring, the functionality includes procurement / receipt of media with ph, sterlity, validity range, manufacturing/expirty date, quantities in containers, issuance for preparation of new media, sterlization references, media transfers, conduct GPT, physical verification of media, record issuance and usage of media for various purpose.

A comprehensive reporting system is available to produce various reports through standard templates. Provision is there for destructing leftover or unused media, prepared media.

Similarly, functionality to manage new cultures, their distribution, usage and reports are also available on micro media such as media masters, media receipts, media preparation reports, media usage and consumption reports, media GPT reports, physical verification reports. Maintenance of media destruction records with due for destruction alerts.

Maintenance of micro / media log books under LIMS integration mode.

Volumetric Solutions Management

LIMS volumetric solutions management provides a facility to prepare volumetric solutions of a specific concentration using chemicals / diluants with standard quantities under bills of materials kind of setup.

In addition, there is a built-in formula/method of standardization of volumetric solution prepared. Normality calculation using standard formula and volumetric stock transfers after prepration in terms of lots for traceability.

Standard set of reports on solution preparation, standardization, stadarization Labels, due/pending for Stadardization, solution transfers and issuance reports with maintenance of column destruction records.

Maintenance of volumetric solution log books under LIMS integration mode.