Software Solutions

OasisLIMS

Laboratory Information Management System (LIMS) read more

LIMZ-RD

For R&D centers / labs, for automation of R&D activities in pharma research specially in FD division and ADLread more

EnviroLIMS EWM

LIMS for environment labs, water quality monitoringread more

True-LIMZ CTL

LIMS for commercial testing labs (with integrated billing)read more

Stabi-M

True web based enterprise software for stability studies data management and compliance with US FDA 21 CFR Part 11read more

Olink

Equipment connectivity, to efficiently transfer analytical data from instruments to OasisLIMS read more

CrisCon ERP

Pharma ERP - Enterprise version: Specially designed to automate various activities of manufacturing unitsread more

CrisCon SFA

Sales force automation, web basedread more

Oasis CMS

Change management and control systemread more

O-Doc eBR

Electronic batch records maintenance software with electronic instructionsread more

Oasis APQR

Annual product quality review and records of batches producedread more

LimsSoftware Solutions > 


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Optional Modules with LIMS - Part B

OasisLIMS may be integrated with following “plug-in and use” add-on modules to cover various quality assurance activities:
  • Change Control Management (CMS)
  • Deviation Management / OOS / OOT
  • Product Quality Review (PQR)
  • Corrective and Preventive Action (CAPA)

Change Control Management (CMS)


Image A comprehensive module that enables organization to effectively manage changes to processes, documents (STPs / SOPs / Procedures), facilities, hardware, software, engineering, products, equipments, protocols and other areas. The module comprises of initiation of change, impact assessment, evaluation, change implementation and closure.

Deviation Management / OOS / OOT

OasisLIMS deviation management tool helps capture defects and assess their risk. OasisLIMS simple deviation reporting option lets you quickly capture details like part, quantity, failure type, and severity. With this module, you initiate and document planned and unplanned deviation with supporting documentation, evaluate and investigate to analyze risk at any point in the process with initial and final risk assessment, resolve problems quickly, keep every department in a loop, integrate and escalate with CAPA Management to manage high risk.

Product Quality Review (PQR)


Image The regulations require an annual product quality review (PQR) of all products that are manufactured at a manufacturing facility. OasisLIMS-PQR module helps you meet objective of verifying the consistency of the existing manufacturing process, the appropriateness of current specifications for raw materials and finished products and the ability of your stability data to highlight any trends, and to identify product and process improvements. The analytical data is captured from OasisLIMS for all the stages the product goes through including in-process and finished stage with batch tracking. Annual product quality review for all the batches of a finished product manufactured during the year / period:
  • Decreases the risk of out-of-specification results
  • Minimizes the risk of rework/reprocessing
  • Decreases downtime
  • Increases productivity
  • Decreases the risk of product recalls
  • Meets all regulatory commitments/requirements
  • Improves communication between production, engineering, quality and regulatory functions
  • Recording of process / raw data on various stages; graphical representation of processing parameters
  • Generation of trend on yield
  • Generation of reports from LIMS on various quality attributes of finished product
  • Storage, maintenance and generation of exhaustive reports on stability studies at different
  • experimental conditions, time points and packaging conditions
  • Data trending of selected tests and graphical representation of analytical data
  • Provision to record and maintain summary and discussion of quality attributes
  • Provision to maintain market complaints data, product recall data
  • Deviations and OOS results handling
  • Change control and failures

Corrective and Preventive Action (CAPA)


CAPA Management helps pharma companies develop a risk-based, streamlined problem resolution process. CAPA Management user-friendly tool includes: Initiate CAPA process, Record investigations and complete by documenting your investigation methods, action plans and approvals. CAPA Management’s investigation process also lets you map actions to their root causes to eliminate defects at their source, ensure CAPA effectiveness. CAPA Management’s reporting capabilities give the tools to identify regulatory threats and areas for improvement. It includes: Departments
Quality assurance, Quality control, Manufacturing, Raw / Packing materials store, Central packing, Human resource, Maintenance, Supply chain, Regulatory affairs, Formulation development, Finished goods store, Analytical Research Laboratory, Contract manufacturing, Information technology etc.


Image CAPA Sources
Deviation management, Market complaints management, Internal audit observations, External audit information, PQR, OOS results, OOT results, Trend analysis report, Environmental monitoring, Equipment calibration / validation failure, Batch failure, Product recall, Stability failure, Change control etc.
  • CAPA Initiation
  • Corrective and Preventive action plan (major tasks, resources required, deliverable timeline)
  • Verification / Effectiveness check
  • CAPA Closure
  • CAPA extension
  • CAPA extension approval
  • Documentation
  • CAPA Report
  • CAPA Tracking log
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OasisLIMS

OasisLIMS is the most comprehensive LIMS software which helps you comply with Schedule L-1 of Drugs and Cosmetics Rules (GLP), US FDA 21 CFR Part 11 norms, PIC/S and EU Annexure 11 guidelines. Our LIMS range includes:
  • OasisLIMS
  • OasisLIMS EL
  • OasisLIMS Web based

OasisLIMS

  • Covers about 70% of the activities / requirements laid down in GLP; remaining about 30% requirements are relating to premises, infrastructure, manual working etc.
  • Through OasisLIMS the documentation is better organized and maintained, always up-to-date for auditing and inspections
  • It is regularly updated with amendments in pharmacopoeias / D&C Act and the Rules/ in-house
  • It is customizable, flexible and functionally rich, ready to accommodate any type of requirement, as per your needs

OasisLIMS saves

  • Cost in QA, QC operations
  • Valuable man-hours of technical staff
  • Time spent on calculations
  • Time spent in writing and checking reports
  • The time saved is utilized for other important and productive tasks in the lab

Key features

Test Methods/Calculations
  • Automatic on-line calculations for more than 175 test methods as per IP / BP / USP / in-house including titrations, dissolution, weight variation, content uniformity, UV, GC/ HPLC etc.
  • Eliminates possibilities of calculation mistakes
  • No time is consumed in calculations: saves significant time of chemists
  • Pre-defined values for dilutions, titration factors, wavelengths, other constants
  • No need to define external formula for calculations
  • One test method can be used for ‘n’ no. of products
  • No need to maintain notebooks for calculations
  • Validated test methods, no-need to verify/ check results
  • Validity checks at all possible levels
Specification Maintenance
  • Specifications for raw materials / packing materials / intermediates / bulk / finished products easily maintained, with the facility of revisions history
  • No need to refer to specifications repeatedly at the time of analysis
  • Facility to maintain SOPs, STPs, calibration procedures, with revision history
Sample login / Registration
  • On GRN / production intimation, sample login takes place in the software with minimum parameters
  • Allows many types of logins such as normal sample, retest, pre-shipment / pre-purchase, OOS, R&D etc.
  • Automatic, unique AR No. (analytical report number) generation for different categories of samples
  • Facility to enter sampling plan for every product/material
  • Sampling details and sampling observation entry
  • Option of partial/reduced analysis
  • Tests automatically allocated to the sample 
Work sheets / protocol sheets
  • Automatic generation of worksheets dynamically, for raw materials / packing materials / intermediates / bulk / finished products, indicating all the tests to be performed as per pharmacopoeia (IP / BP/ USP etc. and/or in-house specifications).
  • User defined formats for entry of readings / observations, as per drugs and cosmetic act and the rules
  • Work sheet may also incorporate method of analysis
  • Calculation sheet (raw data sheet) automatically generated
Generation of COA - Certificate of Analysis
  • Printing as per pharmacopoeial, regulatory requirements
  • Integrity pre-established; no need to check individual report
  • Automatic cross verification of results with the specification limits
  • Automatic decision of approval/conformance or rejection/non-conformance of sample
  • Opinion includes rejection parameters/test also
  • System itself is designed to take decision independently
  • Eliminates possibility of biased opinion
  • Saves lot of time of senior chemists, senior chemists can focus on value added tasks
MIS and other reports
  • Work sheet, CoA, Specifications, SOPs, STPs
  • Sampling sheet, Sample register (category wise), Rejection register
  • Labels (under test, approved, rejected, sampled, quarantined etc.)
  • QC productivity report
  • Analyst performance report
  • Samples pending for sampling
  • Samples pending for analysis
  • Samples pending for entry of readings / observations
  • COA pending for review
  • COA pending for printing
  • Lab performance report on various parameters
  • Sample approval status
  • Samples for retest
  • Products (control samples) for destruction
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LIMZ-RD


Key Features

LIMZ-RD is designed specially for R&D centers / labs, for automation of R&D activities in pharma research specially in FD division (formulation development) and ADL (analytical development lab)
It is web based, built on ASP.Net with the option of MS SQL Server/Oracle Database, central server deployment, scale-able up to 250 users
LIMZ-RD enables collaborative research efforts across far-ranging in-depth R&D activities such as
  • Projects Management
  • Dynamic Recipe management / formulation development
  • Inventory Control and recording of trial batches
  • Sample Lifecycle Execution / Samples Management
  • Stability Studies management as per ICH guidelines
  • Dissolution Profiling with similarity factor/ comparison
  • Analytical Method validation (linearity, robustness, precision, specificity, ruggedness etc.)
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EnviroLIMS EWM


Key Features

EnviroLIMS EMS is developed specifically for environment and water monitoring
It is a web based solution, built on ASP.Net (also available in VB 6.0 Client/Server for small/mid enterprises)
It contains superior data trending features, graphical and tabular representation of resultant data and behavioral trend of a particular sample point in an area/site over a period of time
It also provides for OOS (out of specifications) investigation alerts and reminders for due tasks such as pending for sampling

There is a provision for entry of readings/observations or test results from the filled work sheet for each sampling point, limits appear online

Environment Monitoring

  • Environment monitoring of manufacturing premises, warehouses
  • Airborne particulate count
  • Settle plate exposure
  • Surface monitoring
  • Personnel monitoring
Provision to enter relevant parameters of analysis such as report date, compliance status, temperature, humidity, time of exposure, media details etc.

Water sample monitoring

  • Analysis of water samples: process implementation through LIMS
  • Sample points and sample pull schedules
[read more]

True-LIMZ CTL


Key Features

True-LIMZ CTL is for small/mid public testing labs engaged in sample processing of Pharma, Food, Water, Environment etc.
It is built on VB 6.0 Client/Server, specifically designed
Besides Core LIMS functions, True-LIMZ includes:

  • Integrated billing / FA modules for maintenance of customer groups, rate definitions group product test rate, group test rate, test rates
  • Preparation of invoices/bills
  • Payment receipts recording
  • Credit notes/debit notes
  • Statement of accounts
  • Party ledgers, outstanding reports, sales reports, accounts summaries, etc.