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CrisCon ERP, Integrated Business Software for Enterprises

Specifically designed for pharmaceutical / drugs manufacturing – An Overview

CrisCon is a functionally rich, integrated enterprise-wide information solution that can be deployed in pharma production units. A highly scalable and technologically superior system, CrisCon enables you to integrate all areas of your businesses and increase operational efficiencies across the enterprise. It helps you boost customer satisfaction through better control over costs and enhanced profitability. Designed and developed by Oasis Infotech, to meet the requirements of regulated market segments such as Pharma Production / API Manufacturing, CrisCon supports multi-division and other multi-department kind of organization structures. CrisCon’s flexible design and extensive parameterization allows it to cater to changing business requirements. In addition, its high scalability ensures that usage of application grows with the growth of the business. It is specially designed and developed for pharmaceutical product manufacturers. It gives you a real‐time view of the business and the information needed to make effective decisions. A pharmaceutical company depends on data from every part in the supply chain, inventory receipts, quality control and quality assurance test results, payments for purchases, production records, customer orders, shipments and invoices, payments from customers, maintenance of equipment and facilities, financial accounting and taxes etc. and CrisCon is specifically designed to manage pharma specific activities like multi‐pack, multi‐size finished goods, shelf life and batch expiry control, product formula and specifications, centralized and approved purchasing. CrisCon Software comprises reports set and MIS, which gives the customers power to run businesses smoothly and efficiently.

Business Benefits

• A complete and integrated solution • Maximized productivity and efficiency • Reduced costs • Optimized processes • Technology to transform your business into an e‐business • Quick and easy implementation with best practices for pharmaceuticals
Salient Features
• Adherence to cGMP and cGLP • Supports multiple Divisions • Facilitates multiple currency transactions • Purchase management • production planning and execution • Sales management • Sales Analysis - representatives achievement • Compliance with statutory requirements of FDA, Local Taxes etc. • Can integrate with existing legacy systems • Audit trails for addition / modification or deletion • Batch Control from purchase of material to sales • Costing of product throughout the production life cycle • Exchange Rate variance (Foreign Exchange) • Balance Sheet with Schedules, Cash Flow & Fund Flow statements • Analytical reports with graphical presentation as MIS & DSS • Single‐window data capturing • Menu‐driven System Administration to manage Users, creation of roles/privileges, assignment of user‐rights and setting business rules • Security management (Module level, Form level, Operations level)

List of Modules
• Purchase management • Inventory Management and Control • Production Planning and Batch Management / BPR and BMR Maintenance • Quality Control and Assurance through Integrated LIMS • Sales Management • Financial Management • Payroll • Cost and Controls • User Administration

1. Purchase Management

Purchase management and material procurement process initiation from production department Indicates Shortages of Material for execution of plan Material procurement cycle Indent / Enquiry / Quotation with approved vendors Quotation Comparison & Analysis, the module triggers enquiries to approved vendors and captures information of quotations submitted by Vendors in response to these enquiries. Purchase Order creation with facilities for imported, staggered deliveries, multiple currencies Interface with Stores and Finance Report on pending PO’s and reminders to suppliers Purchase Rate History Vendor Analysis: Analysis of approved vendor on the basis of on‐time deliveries, returns, quality of goods, rate and other purchasing statistics The status of the Procurement of the Material is available for review at each process stage in the Procurement cycle Purchase return management Purchase rate variance against standard rate

2. Inventory Management and Control

This Stores Management module automates the receipt, storage and issue processes from the Purchase Order generated by the Purchase Management module to the Manufacturing / Packaging Record. Materials are received from vendors at the Warehouse Stores at batch / lot levels and are placed in the quarantine area. Goods Receipt & Inventory Management: Follow‐on activity to purchase order GRN captures information like vendor's batch, AR Number, system keeps track of multiple dates at the batch level, including Expiration, Manufactured, Best Before, Shelf Life, Re‐test dates etc. Material, in excess of tolerance limits, is checked. Generation of intimation to QC for quality control activities, Quality Control (QC) draws standard quantities as samples and performs various tests based on the Pharmacopoeia grade and then approves / rejects the same. Stock Status: The stock in a warehouse is categorized as Open (unrestricted), Under Inspection / Analysis (restricted) and Blocked / on Hold The Stock Statement is available for any desired material and desired period Material Issue or Dispensing is according to stage wise Bill of Materials (BOM) that is defined for each product. Store generates a pick list and material tickets to facilitate materials moving to production. The system suggests an issue logic, which is based on ‘First Expiry First Out’ (FEFO), generation of Requisition and issues (RM / PM) on Potency basis after applying assay and LOD factors in issuance of materials. ABC analysis, FSN Analysis / Helps in reduction in unnecessary inventories The module also features extra usage requirements, usage returns, stock adjustments etc. Interface with Production, Quality and Finance (Accounts Payable) modules

3. Production Planning and batch Management

Product formula / BoM: Enables to define formula consisting of Raw Material (RM), Coating Material (CM) and Packing Material (PM) for theoretical batch size of the product. Materials resource planning on the basis of sales orders and routine production demands, system has provision to pull out three months advance planning of production batches accordingly requirement of raw, packing materials is generated to optimize and reduce inventory carrying costs where working capital in hugely engaged. Facilitates to define various tasks / operations for Batch manufacturing (BMR) and Packing Process (BPR) The Batch Manufacturing Record (BMR) and the Batch Packaging Record (BPR) is a stage wise capture of material inputs to the batch and the stage wise declaration of production output and yield. This BMR / BPR tracks the manufacturing process of formulation through its various stages – the system provides for capture of stage wise bill of materials. Excess materials consumed in the batch or returned from the batch are traced to the BMR / BPR. This facilitates the generation of stage wise batch cost. Production WIP is tracked at each stage in the manufacture of bulk and packaging. Hence Product batch wise WIP valuations are constantly available. Production Process: Facilitates step‐by‐step entry of the batch manufacturing process maintaining complete documents for the same (adherence to cGMP). Allocation of manpower and equipment utilization task‐wise, facility to enter IPQC Results for the task / operation Monitoring of Material Yield Product‐wise, Batch‐wise, Stage‐wise WIP / Recovery transfer: Transferring bulk, blend etc. to WIP warehouse and Intimation to QC for testing Production cost per machine per hour includes parameters like overheads, depreciation, interest, cost of planning, inspection, operations and power consumption etc. Equipment calibration Valuation of the work‐in‐progress inventory including cost of raw material and value addition at each stage of production Interface with MRP, Quality, Costing, and Sales

4. Quality Management through LIMS - Laboratory Data Management

Enable the product quality performance monitoring and management Define the test specification for the quality management during production (for IP, BP, and USP etc.) Quality of Goods Receipt: Quality Management / Batch Management, ensuring correct quality is purchased, QM inspection results against limits to verify acceptance of materials Laboratory Integration: Integrated quality control, according to cGLP functionality like In‐Process Quality Control on Standard, Storage or Order specific request for QC Calibration of Test Equipment: Automatic generation of calibration orders on a regular basis and execution with calibration instructions Reagent maintenance: Date of preparation, expiry, re‐test due for the reagent Generation of Worksheets for chemist with sample and specification details Labels printing – Sampled, Under‐test, Approved, Rejected etc Quick retrieval of Certificate of Analysis and Analytical Report Rejection Analysis helps in improving Material and Supplier Performance. Interface with MRP, Production, and Accounts Payable

5. Sales Management and Analytics

Quick and Flexible order entry for variety of item types including kits, configurable products and services. Customized treatment for pricing, tax and discounting mechanisms, to handle various commercial policies Multiple order processing Order booking / Pack‐list / Invoice Generation Product issue based on FIFO, FEFO, near expiry and selected batches Scheme management for sales promotion Return goods management ‐ adjustment of customer balances and sales returns Payment from Distributors and adjustments against Accounts receivable Batch hold from invoicing Distributor management using maximum credit limit, minimum dispatch limit, maximum invoice value and hold transactions Sales targets against achievements based on primary and secondary sales data Interface with Material Distribution and Finance

6. Financial Management

The general ledger module integrates with accounts receivable and accounts payable, covering budgeting, financial reporting. Accept details of vouchers, cash, bank receipts and payments Reconciliation – Bank reconciliation on regular basis Financial Statement, Statutory and management reports like Cash, Bank, Journals, Credit / Debit Notes, Ledgers, Trial Balance, Balance Sheet and Profit & Loss Accounts Receivable keeps track of Receivables with automatic data update from Sales Management system Accounts Payable keeps track of Payables with automatic data update from MRP and QC Payment Planning based on Purchase Terms Distributor‐wise ageing analysis is available Sales Tax Register Depreciation on fixed assets Statement Interface with MRP, Production, QC, Sales, and Payroll

7. Payroll

Process employee wages and salary Time Management optimizes processes for planning, managing, and evaluating the working times and activities of employees. Payroll processing includes Payroll Accounting, Dearness Allowance, and House Rent Allowance, Tax, Insurance, Travel Expenses Administration, Incentive Wages, Posting to Accounts. Employee increments Statutory reports to Provident Fund commissioner office, Incometax office, Salary advance, bank loan, employee society Management Employee demographic data for HR Attendance and Leave management

8. Cost and Controls

Cost centre: Definition of cost centers in the manufacturing process Process cost determination, Process cost monitoring, Activity based costing and Plant capacity utilization Batchwise, Taskwise Raw Material, Packing Material showing standard quantity vis-a-vis actual used with standard deviation Batchwise, Taskwise Recovery, Byproduct showing expected quantity and actually generated Batchwise, Taskwise manpower and equipment utilization Costcentrewise equipment utilization for various costing parameters Revenue & Cost Accounting: Provides valuation and recording of financial data as the basis for all cost and revenue related reporting. Trend Analysis – Process Cost

9. User Administration

Menu‐driven CrisCon administration to manage users, user roles / privileges Security management (Module level, Form level, Operations level) The audit trail can be viewed by the System Administrator CrisCon Software – CrisCon Solutions for Pharmaceutical Industry

Oasis-EBR Electronic Batch Records


An integrated software for maintenance of batch manufacturing and packaging records, electronically! On-line manufacturing records entry through electronic batch records (EBR) with electronic work instructions (eWI); Easy compliance with cGMP Regulations.;Specifically designed for pharmaceutical / API / Chemicals manufacturing units. Escalation of batch records helps improve process management efficiently, increases quality, and ensures compliance.

Key features offered by Oasis EBR ...

Master Batch Records (MBR)
Pre-configured forms/Files Forms/Documents outline/Details of Mfg. processes Governs an individual Mfg. run Pre-Defined/Configurable Templates
Documents Preparation
Upload Attach/Link – files Quick Storage and Retrievals Under Secured Database Operations Completely User Defined Reuse Existing BMR/BPR documents
Production Batch Records (PBR)
Macro Objects for process parameters recording Capture all related information of Mfg. process Mfg. procedures as Electronic Instructions Multi-page information capturing Paper-less Manufacturing
Process Workflow Automation
Sequence of operations/Automatic routing Serial Steps / Adherence to workflow Complete recording and verification of INFO
QA Stage Approvals
Reviews and approvals Authorization / Electronic Signatures Feedback submission at all levels Track and Trace
Automatic Notifications
Reviewers and approvers automatically notified Off-line alerts and reminders
Pending for review, for approval, for action BR printing Master Batch Records/Controlled Copy Batch Manufacturing Records Batch Packing Records Manually stamping paper pages to ensure accurate manufacturing/production records is a time consuming and costly endeavor. Electronic batched printing of records provides a controlled solution for producing consistent documentation for paper-driven processes. Issuing consistent manufacturing records (BMR/BPR) has never been more convenient than with the BPR pre-stamped lot number feature.

Business Benefits

Batch operations conducted and maintained manually are inherently inefficient, slow and cumbersome. Oasis EBR system streamlines and standardizes work practices on shop floor. Eliminates stamping each page of a record with lot numbers/batch numbers/ticket numbers/etc. Simply type batch related information at once and it populates statutory information in all required locations within the records and relevant documents.

Eliminate and streamline work practices, Reduce complexity of printing Embed knowledge of printing records, effectively manage manufacturing records Rapid employee adoption and use, Flexible printing solutions, Regulatory compliance Microsoft .Net application built for secure document management, as well as simplified change management and validation, Option to Interface with ERP / LIMS system Document Control & Archiving (DCA) / MPCR, Recipe Authoring (RA), Equipment Tracking (ET), Materials Management (MM) / Weighing and Dispensing, Electronic Batch Records (EBR) , Security & Audit (SA)
Oasis EBR automates escalation of batch records for more efficient process management, The process entries such as tare and gross weights, start and end times, environment parameters and setup verifications etc. can be recorded on line. Pre-configured forms simplify data collection and help minimize errors common in manual data collection. Separate Fully Functional Module with user access restrictions .

Integrated key functions offered by Oasis EBR ...

Electronic Templates, flexible

Built in word processor for maintaining batch and packaging records as standard template* with each product formula / recipe, Every stage has templates attached to it (meant for recording process parameters, observations and operators entries), Provision for revisions. *programmed configurable eFoms having manufacturing procedures/instructions and provision for user entries inputs with text boxes, check boxes, option buttons and calculations

Attachments e-Forms

Creation of Production login / work orders (new batches) automatically attaches standard templates as on-line electronic forms (eBMR) for subsequent recoding of process parameters, observations and operators entries

Real-time Operators Entries/Recording

Provision for user entries inputs with text boxes, check boxes, option buttons and calculations, Synchronized with production workflow

Approval System, Authenticate Action

QA approvals and controls with every stage, Any deviation or exception can be commented with corrective action

Time Stamping / Electronic Signatures

System time date stamping with shop-floor manufacturing; provision for electronic signatures

Automatic Tracking

Oasis BR tracks all routing information and data entered into the electronic form, allowing the batch coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing. Physically tracking logs, test results, and other records from different areas is time-consuming. A manual process makes it almost impossible to avoid bottlenecks, a serious problem in case of a need to identify defective batches.

Data Capturing from ERP

In-line insertion of relevant informaton from ‘Production Module’ to eForms, batch details, product formula, issuance records, issue returns, man/machine operators entries

Effectively Manage Manufacturing Records

Easily transform paper-based manual manufacturing record systems into a computer-supported system. Existing documents compatible with MS Word/ASCII text can easily be imported and attached with EBR database, reduces time for master preparation while implementation.

Reduce Complexity Of Printing Records

Batch manufacturing records often comprised of various documents that are printed separately and compiled later. With Oasis-eBR, the compilation of various documents is done adherence to Master Batch Control Record, so that one never forgets a form or document again.

Rapid Adoption and Use

Attractive and easily understood production record printing application guarantees rapid employee adoption and use.

Embed Knowledge

Oasis EBR system standardizes the knowledge of work practices; this results in reducing repeated higher training costs and less room for errors. With Oasis-eBR, you can embed work practices within the application so that the knowledge of manufacturing process remain and maintained with in the system. The practice would be system driven then man driven.

Regulatory Compliance

Automatic audit trail and other control measures ensure cGXP and 21CFR Part 11 compliance for those industries requiring such.

Equipment Interfacing through O-Link Server

To capture / upload data from weighing and dispensing instruments installed on shop-floor.

User Administration

Plant Master, System Users, User Profiles, User Session, Web Browser, Un-Authorized Use Report, Backup Database, Recover Database, Function Key, Format Master, Logout, Lock, Change Password, Preference, Mail, Alert/Reminder, Exit

Integrated Equipment Management, (optional)

Equipment Type Master, Equipment Unit Master, Equipment Master, Equipment Maintenance, Equipment Test Master, Equipment Test Link, Calibration Login, Calibration Reading/Observation, Equipment Master List, Equipment Test Link printing, Calibration Worksheet, Certificate of Calibration, Equipment Calibration Status, Equipment Due for AMC, Equipment Maintenance Report, Equipment Due for Calibration, Equipment Calibration Calendar, Equipment Pending for Calibration, Equipment Register, Alerts and reminders (pop up window)

Equipment Management System


Oasis EMS is a software system capable of data management for equipment/instruments used directly or indirectly for production, testing and release of product at any manufacturing facility. Oasis EMS system provides integrated functions that allow users to define and closely monitor equipments, manage calibrations, maintenance and usage records, it automates the complete process of equipments management such as ...

  • Calibration scheduling, calibration results recording

  • Scheduling of the preventive maintenance and capturing the preventive maintenance details

  • Problem reporting and capturing of the service details

  • Management of Annual Maintenance Contracts

  • Engineering Inventory Management

  • Management of Work orders

  • Engineering Inventory Management

  • Operations/usage logs

  • Cleaning Logs

  • System keeps track of instrument history maintenance records

Key features ...

Equipment / Registration

List of equipments with thier complete details including name, make, model, date of purchase, location, service vendor, AMC / Warranty contracts, Frequency AMC/Calibration, SOP etc.
Equipment Specification, for calibarion
Test specifications for Equipment parameters can be easily maintained, with the facility of revisions history.
Equipment Calibration Login
System allows many types of logins such as normal calibration, scheduled/un-scheduled etc. generation oif Calibration Work sheets / protocol sheets with Tests to be performed.
Calibration Result entry and Report
Result entry, test wise, based on user defined input and output parameters Generation of Calibration CoA - Certificate of Analysis with next calibration date. Equipment calibration calendar, Equipment calibration report, Equipment due for calibration, Printing of equipment calibration status report Equipment Calibration Register report
Management of Preventive Maintenance and AMC
Equipments Due for AMC Software manages preventive maintenance details of equipment, Work order management, software generate, categorize, track and manage the work orders (ticketing system)

Equipment Breakdown Maintenence Procedures

Equipment Break Down Logs, with date, reason and details specified. Work order generation, date, compliant details - Minor/Major. Integrated Engineering Items/Spares/Tools Inventory Management Track and manage purchases of Engineering items and inventories Service Records / Engineering Items Issuance / Spares Consumptions / Part Management Maintenance records, services against work order, spares required in repairing and other relevant details can ne maintained. Recording of equipment maintenance activities along with visit number, date, problem, contact person, Time In /Time Out and Remarks details. Equipment Maintenance Out-side, Dispatch/Receipt
Other various visual dashboards
MIS, dashboards and reports
For electronic systems
Access / Authorization, User Id and Password control, Data Integrity and Accuracy, Audit trail, Data Backup and Retrieval, Electronic Signatures, User Documentation

Oasis-CTMS, Clinical Trials Management System

Oasis CTMS is specifically designed to manage the entire cycle of clinical trials processes and studies, bio-analysis starting from schedules, registration of sample to the final results, it automates the complete process workflow of laboratory with regulatory compliance…

  • • Protocols/study designs and Projects Management
  • • Lab process across all sites
  • • Increase efficiency by automating data handling and reporting task
  • • Compliance throughout the process for data integrity
  • • Track study, sample history from receipt to disposition, summaries

Master Database – Volunteer’s/Subjects
Provision to maintain subjects/volunteer’s demographic and physical parameter data such as name, age / sex, address, phone etc. Provision for reports on subject’s demographics, consents, clinical notes and testing results Entry of doctor / consultant / customer master with name, address, phone etc
Test Management
• Type of tests

• Test library for laboratory tests

• Test profiles

• Test Details - Test Limits / formats

Study Design and Protocols
Model flexible study designs and protocols, apply amend protocols during study with integrated change management module of Oasis-QMS … integrated electronic signatures at all levels
Define key elements of research / trail protocols
Comprehensive projects management module with study timelines / TCD’s Study types, blinded / un-blinded with encoding / decoding Track down study progress through project management graphical interface Gantt charts Study lock, close-out and archival
Protocol and Study management
Provision for study protocols logins with the facility of amendment with revisions history Protocols amendments to be handled by integrated change management module of QMS Integrated electronic signatures at all levels of protocol approvals Study Tracking with projects management Study report tracking with graphical interface Study lock, close-out and archrivals
Regulatory Submissions
Design various user defined forms as pre-requisites for clinical/non clinical studies and trials such as …
  • • Contracts
  • • Negotiations
  • • Volunteer's / subject consent forms …
  • • Demographic data, physical parameters etc.
  • • CRA appointments
  • • Subject allocation
  • • IRB and Ethical submissions
  • • Registrations
Regulatory Submissions and compliance
Upload and maintain various Forms / Formats such as Customer Contracts Negotiations CRA appointments Subject allocation IRB and Ethical submissions Registrations Controlled system access to authorized users, role bases access to ensure authorized actions can be performed by users in accordance with GLP. Provision for audit trails of all events performed in system, create, change and delete Electronic Signatures with user identity and password, time/date stamp and reason for change / delete as required by 21 CFR Part 11 International Regulatory Compliance (US FDA/ GCP)
LIMS and Bio-Analytical Module
Path lab software design to support BE/clinical trials Provision for entering schedules for sample collection Sample receipts with barcodes to identify and track samples on labels; software driven barcode label printing Provision for sample logins with on-line selection of tests to be performed on sample Provision for work allocation of sample tests and Generation of worksheets, department wise – bio-chemistry, haematology, microbiology Provision for test-wise results entry Generation of ‘Final Test Reports’ and other sample reports, test reports approvals with electronic signatures, QA reviews and re-assay management Provision for handling of adverse events / serious Adverse Reactions to be integrated with QMS for investigation and further action with CAPA Reports and Data Transfers
Test definitions / Sample Receipts and Management
Management of tests and limits, group tests / profiles Create fixed and flexible schedules for sample collection, sample receipts (create new or imports existing barcodes to identify and track samples. Provision for samples dispatch to central clinical / Bio-Analytical Lab with Transportation / logistics details … and receipts confirmations at Central Clinical / Bio-Analytical Lab followed by registration / login’s of samples with test/profiles allocations. Define sample locations, track down to shelf positions
Reading / Observations – Results Entry
Work allocations and worksheets, department wise – bio-chemistry, hematology, microbiology to conduct and analyze a wide range of routine and customize test with the provision to enter raw data, observations/readings and results in electronic form etc. Data Acquisitions, OasisLIMS / O-Link module integrates with various instruments having data acquisition interface to capture data directly which helps preserve data integrity. Provision for samples dispatch to central clinical / Bio-Analytical Lab with Transportation / logistics details Generation of Final Test Reports and other sample reports Adverse Events / Serious Adverse Reactions
QA Reviews and Re-assay management
Test reports review and approvals with electronic signatures Review the history and attributable changes in Audit Trails pertaining to execution of sample life-cycle. Identify re-assays and decision on sample repeats
Reports and Data Transfers
Customize data export to client requirements and report in industry standard formats, secure the reports under document management system.

Some reports at a glance …

Master data … Protocols, Study Reports, Project, Gantt Charts, CRF, case report form, SOPs / STPs, Volunteer's/ Subject Data, all pre-requisites forms - RA, Schedules, Sample registers, Barcode Labels, Work sheets, Test Reports / Certificate of analysis, Pending Schedules, Samples pending for registration, Samples under analysis, Samples pending for analysis, Test Reports pending for reviews, Sample status – track from receipt to disposition, Re-assay – repeat samples, Deviations - Adverse Reactions, Lab performance data, ... automatically flashed and directed to concerned users by issuing alerts and reminders in the logon screen home window User Administration Multiple – lab / satellite lab setup User Profiles User role / rights Report Approvals / authorizations etc.
…multi Labs / sites access, client access across the globe
... Ideal solution for Clinical Trials having wide range of clinical services and networked with hospitals connected to central clinical / bio-analytical lab. Using centrally deployed Oasis-CTMS, helps coordinate studies in a timely and efficient manner by making data available enterprise wide.

Regulatory and Other functional Requirements

Compliance throughout the entire process
Built-in DMS, assists users to comply with SOP’s, reduce risk of non-compliance Automatic pre-configured workflow allows users to follow standard workflow, without any deviations System access controlled, access granted to authorized users, role bases access ensures authorized actions can be performed by users in accordance with GLP. Audit Trails are stored in database, readily retrievable for review for all events performed in system, create, change and delete. Electronic Signatures record user identity, time/date stamp and reason for change / delete as required by 21 CFR Part 11.
Oasis LIMS provides highest level of system and data integrity, enabling fool proof security systems in place and also controlled system access. System Administrator has complete control in defining users, user roles and access privileges to use specific functionality of the system and right to authorize actions of other users. There is provision to implement electronic signatures with time stamps and unique user IDs and passwords are allocated to individuals
Audit Trails
LIMS includes one of the most comprehensive computer generated date and time-stamped audit trail and trace logs. This enables systems to maintain audit logs for all operators entries, to check who did what and when and why and where. All changes are recorded instantaneously and subsequently stored for future use during auditing and inspections, or QA reviews

Integrated Oasis CTMS Modules (Optional)

Integrated Document Management System
Define folders/sub folders to efficiently manage documents / raw data Prepare, edit and maintain STP’ and SOP’s, create/ apply amendment with full revision control and review dates Quickly built study report , incorporate documents, tables and graphs with full word processing capabilities with the facility to import or attach existing documents/files in a flexible manner. All reports and data is held in database which is controlled securely by user access and system roles.
Oasis-QMS – Integrated Quality Management Module …
a comprehensive web based tool that enables organization to effectively manage quality processes and record deviations pertaining to documents, STPs /SOPs / Procedures, protocols and other areas. • Change Control Management • Deviation Management • Incident Management (Lab / Environment) • Corrective and Preventive Actions
Add-on modules that empowers basic LIMS functions
LIMS has various add-on modules to work in conjunction with main LIMS activities, for better management and control of quality assurance operations • Trend Analysis • Equipment calibration management • Standards management • Samples retention management • Training records management

General Requirements

Reminders of overdue tasks and activities, pending for review, pending for approvals, due calibrations/AMC, due training, due sample collections etc
Data Integrity, Data security and access restrictions
Ensure subject data and sample privacy using multi level authentication for user-role based access control.
Audit Trail
Keep track of all user activities performed in your lab with a comprehensive audit trail.
Statutory guidelines
Work in a regulatory compliant environment by using electronic signatures and by maintaining audit trails. Follow 21 CFR Part 11 regulatory standards with ease.
Query Capabilities
Identify and locate specimens of interest for clinical research purposes with flexible and easy-to-use query templates through the system’s seamless graphic interface.
Easy configurable workflow to fits in unique environment and eliminate tedious manual entry
Back-up and Restore
Provision for system data backup with disaster recovery procedures

Oasis EWM, Environment and Water Monitoring System


Oasis Environment and Water Monitoring System

It is a process based solution that maps to entire sampling workflow; the software controls the process as a whole, not just scheduling for individual sampling points/locations, but also capturing all critical quality control parameters. Risk-Based Environmental Monitoring involves monitoring the quality of production area, incoming water, air and gases are critical for the quality of the finished product. Water is used in several areas of pharmaceutical and if contaminated can lead to poor quality product, the same apply to gasses used in production. This increases risk of adverse patient reaction from the final product and that may lead to regulatory citations.

Quality Parameters and Limits

In a hierarchy, there are geographic locations/sites and at each geographic location/site there are sample points distributed. For each location/site/area along with sample point quality parameters are mapped with predetermined limits.

Automatic Scheduling

Provision for batch related or on-demand scheduling of analysis for area, sample point and tests at a specific time interval (Analytical Report No is generated automatically on a predefined theme, date of monitoring/exposure and analyzed by entered.)

Reading Observations/ Results Entry

Rapid data entry, readings/observations and test results are entered for each sampling point, limits shown online.

Reporting and Data Trending

Comprehensive reporting capabilities and real-time trend view features allow one to analyze data going out of range quickly and efficiently against limits for selected filter to include date range, site/location/area, sample points.

Other various visual dashboards

MIS, dashboards and reports

For electronic systems

Access Control - User Id and Password, Data Integrity and Accuracy, Data Backup and Retrieval, User Documentation.