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Pharma Soft Sol

Hyderabad, Telangana

| GST  36AANFP3043P1ZP

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Laboratory Information Management System

Offering you a complete choice of services which include SoftLIMS -Stability Management System, Working Standard Management System, Solution Management System, Label Management System, Chemical Management System and Instrument Management System.

SoftLIMS -Stability Management System
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Stability Module in softLIMS is a complete software to meet the requirements in pharmaceutical stability testing programs and stability management. It can be installed at your server and access from anywhere with your web browser.

softLIMS Stability Module manages your  total stability testing program , so you can provide required stability data  to regulatory authorities  with out delay and analyze your data statistically.

softLIMS Stability Module is a well developed software that organizes efficient study management, flexible storage conditions and testing capabilities which satisfy all regulatory criteria for your real time, accelerated or forced-degradation study requirements.

Key Features:

  •     Preparation ,Review and approval of Stability Protocol
  •     Stability Management Module provides Stability tests schedule over varying periods of time with varying intervals, as defined in the Stability Protocol
  •     Automatic generation of AR Numbers as per Protocol for each sample interval
  •     Automatic calculation of test results and Individual COA generation
  •     Summary to show the Status flow of work
  •     Individual Job Allotment Option to Analysts
  •     Option to take Print out of worksheet for Analysis
  •     Provides various reports like protocol reports ,schedule report,COA reports,quantity withdraw report,schedule deviation reports etc.
  •     Complete audit trails for all critical activities

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Working Standard Management System
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softLIMS - Working Standards module enables registration of each Working Standard and the individual lot prepared or registered under it. Working Standards Management module keeps track of inventory and usage of Working Standards in Quality Control laboratory. The main functions are summarized below:
Key Features:
  •         Working master creation or registration with lot details.
  •         Effective maintenance of Working standards on the basis of procurement details, source, assay, standardization, usage etc.
  •         Working standards issuance with required quantity to the test batch.
  •         Working standards stock details or report.
  •         Working standards usage report/consumption report.
  •         Working / working standards - use before date or automatic expiry date population with notification.
  •         Internal or External Lot creation.
  •         Alerts and reminders.
  •         Reports of WS vial preparation, usage, destroy,stock card,COA.
  •     

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Solution Management System
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Solution Management Module covers registration of each Reagents, Indicators, Buffers and Volumetric Solution. Volumetric Solutions is prepared as per the standard operating procedure and capped and labeled with name, date and description of the contents. To ascertain the strength of volumetric solution it is standardized by titration.

This module enables the complete process from preparation of templates to ensure the chemical composition integrity, standardization, re-standardization and usage. This gives a comprehensive functionality to address the standard volumetric solution practices. A tight integration with sample management in LIMS gives the possibility to enforce the usage compliance. Reports include Standardized Solutions Inventory, Re-standardization Due Dates and usage for different purposes.

Key Features:

Master Solution Creation with details of required standard solution name, type etc.

Standardization and standardization of volumetric solution after preparation.

Raw data report for solution preparation.

Solution usage Record.

Tracking or Solution Status based on name and solution type

Validity Notification before expiry of solution.

Termination of the solution.

Provide various reports like solution preparation, standardization, standardization usage, termination, solution index,

Audit trail for all critical activities

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Label Management System
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Label Management System

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Label Management is specially designed to meet various stages of label requirements like quarantine, approved, in process and finished etc.

These Labels are also designed to clearly identify various stages of production, manufacturing, testing and packing process in the organization.

Key Features:

  •     Required template creation for the label like finished product , Raw material , In process , working standard etc.
  •     Template can be created with required size and print details.
  •     Barcode feasibility for the Label.
  •     Quantity or number can be based on the requirement with sequential number.
  •     Label Reprint option.
  •     Provides reports for Label print, reprint request, reprint report.
  •     Audit trail for Label template, History of reprint.

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Chemical Management System
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One of the  biggest challenges to regulated industry Quality control Lab is  management of chemicals. Even we have many latest systems in place the management of Chemicals is equally plays a vital role to comply with regulatory requirements as well as GLP Practices.

The management and control of chemicals is the responsibility of the Quality Control department which involves in the procurement, stock entry, issuance  and disposition of chemicals. As there are many chemicals are used in the laboratory for different purposes, physical maintenance of chemical  inventory  become a tedious job to the department or company. Hence automation of chemical inventory management makes the job easier. Chemical Management module covers all the activities like Registration of Chemical / Chemical Lot, Maintains complete inventory of the chemicals.

SoftLIMS – Chemical Management Module gives a complete solution to  Lab chemical management.

SoftLIMS- Chemical management module  is a well developed software that handles all chemicals management, with flexible features  which satisfy all regulatory criteria for stock maintenance, consumption and destruction of the chemicals in the Lab.

Advantages of  PSS - Chemical Management :-

  •     Chemical registration with unique code or material code
  •     Automatic Stock statement & Stock card for each chemical
  •     Chemical Issuance, Destruction and Expiration traceability

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Instrument Management System
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Maintenance of analytical instruments data is required by many national and international regulations, quality standards and company policies. The analytical instrument usage relies on the accuracy and precision to obtain valid data. This data can be used for various purposes at quality control lab.

Instruments are increasingly utilized based upon integration with computers to improve and simplify control ,enhance and extend instrumental functions, conditions, and parameter adjustments and streamline data sampling, collection, resolution, analysis (both during and post-process), and storage and retrieval.

Advanced instruments can be connected as a local area network (LAN) directly of via middleware and can be further integrated as part of laboratory information management system (LIMS).Instrument connectivity can be furthered even more using internet of things (IoT) technologies, allowing for example laboratories separated by great distances to connect their instruments to a network that can be monitored from a workstation or mobile device elsewhere.

To meet all current industry and regulatory requirements Pharma Soft Sol designed instrument management in LIMS module.

Key Features:

Automatic Instrument number population.

Automatic numbering for same instrument category instruments.

Manage documents related to instrument.

Schedules Calibrations and Automatic Notifications for Calibrations.

Work Sheet generation for calibration activity and results entry.

Automatic Calibration Certificate Generation.

Calibration overdue alert notification.

Deviated jobs automatic population.

Assign Calibration activity to the required User.

Instrument Use Log provision to record instrument usage.

Instrument breakdown and termination options available.

Deliver notification for Annual maintenance contracts.

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Column Management System
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Column Management System

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One of the  biggest task to regulated industry Quality control Lab is  management of columns. Even we have many latest systems in place the management of Columns is equally plays a vital role to comply with regulatory requirements as well as GLP Practices.

The management and control of columns is the responsibility of the Quality Control department which involves in the procurement, usage  and disposition of columns. As there are many types columns are used in the laboratory for analytical purposes, physical maintenance of column  inventory  become a tedious job to the department or company. Hence automation of column  management makes the job easier.

About softLIMS – Column Management

SoftLIMS – Column Management Module gives a complete solution to  Lab column management.

SoftLIMS- Column management module  is a well developed software that handles all columns management, with flexible features  which satisfy all regulatory criteria for maintenance, consumption and disposition of the columns in the Lab.

This module enables registration of column application like HPLC/GC, individual column IDs, column assignment to product/Material testing. System suitability parameters can be defined as performance tests. Columns will be subjected to an initial acceptance test based on the performance criteria specified for the assignment. The module also provides for regular usability tests and usage records and column regeneration to meet GLP requirements. Reports include available columns status, Column suitability &acceptance certificates and Usage records

Key Features:

Separate Registration for each column type and column

Provides Complete Column inventory with all details like Type, Material, particle Size etc.

Automates tracking of no of injections & columns approaching maximum no of injections can be notified

Automatic numbering for each column type.

Qualification of column before usage.

Column Usage details with product recording and report generation

Provides wide variety reports like complete Column index, Usage, Destroy, Qualification & column type.

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Environmental Monitoring Management System
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softLIMS – Environment Management Software module is a specially developed software for microbiological monitoring data specially related to classified or controlled environments. In clean room manufacturing, the environmental monitoring program is one of the most important environment controls. softLIMS EM module tracks all the environmental monitoring process, from sampling to microbiological counts, passing through phases of incubation and reading results.

The software supports registration of sampling points, area classification, sampling types and schedules.softLIMS – Environmental Management module enables monitoring of individual environment sampling point monitoring

Advantages:
  • Suitable to different types of samples like settle plate, volumetric air sampling etc registration.
  • Room wise sampling point registration.
  • Area classification with sampling, Room map view with sampling points
  • Logging single or multiple samples with automatic number assignment
  • Schedules with due dates and notification
  • Track samples and sampling schedules with ease.
  • Comprehensive reporting capabilities
  • 21 CFR Part 11 Compliant / Annex 11 Compliant
  • Reduced regulatory & business risks
  • Real time data trending & analysis
  • Alert and action level for each sampling point
  • Improved operational efficiency saving time & money

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Water Analysis Management
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Monitoring the quality of water on a regular basis is required for producing the quality product. Many companies face difficulty in handling of water analysis management. SoftLims is one of the solution to get rid of that difficulty.

softLIMS – Water Analysis Management is designed to meet various types of water samples analytical data maintenance with reports. It is specially designed to meet the pharmaceutical and biotech industry water analytical requirements.
Water Analysis – Features

Suitable for different types of samplings like Raw water, RO water, PW,WFI etc.

Can Create Water Specifications,tests,parameters as per In-house or pharmacopoeia.

Logging single or multiple samples with automatic number assignment.

Track samples,sampling schedules and AR No.s with ease.

Can Create sampling points,locations and frequency as per requirement.

Can Create and modify schedules for sample collection based on requirements.

Can generate Sample specific AR No.

Automatic worksheet generation.

Results entry after sample analysis & Approval.

Automatic notifications for Alerts,Notifications,OOS,schedules deviations.

Historical water data trending’s and graphing.

Schedules approaching due dates can be notified.

Wide variety of reports available like sampling point,fail jobs,schedules,Incubator usage etc.

21 CFR Part 11 Compliant / EU Annex11 Compliant.

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Control Samples Management System
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About Control Sample Management System:

To meet all regulatory requirements for Control /Retention or Reference Samples Pharma Soft Sol designed Control Sample Module integrated with   SoftLIMS.   We can track the any control or retention sample status in no time. In addition to the same we can generate the history and retest due dates automatically.

Control sample management  give the flexibility to use the software from product wise registration to control samples expiry along with retesting and destruction record.

The following are the some of the feature that are present in the module.

  •     Control Sample Registration based on the Sample Type
  •     Retest option to Control sample Tests with alert notification
  •     Separate flows for Pass and Fail samples
  •     Option like Control sample Requisition, Distribution and Re-Keeping
  •     Destruction option for Registered samples
  •     Auto updating of control sample records

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Sample Management System
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Sample Management System

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softLIMS sample management is designed to meet the complete sample analysis requirements in a quality control lab.

softLIMS present accurate, unbiased information that enabled Sample Management to maintain the highest standards of safety, regulatory compliance and control of data without any data integrity issues. With Sample Management Module, a LIMS would enhance company analytical performance, which allows the user to complete the analysis in time.
Key Features

Sample Registration Option with Unique AR Number generation for Sample Types Like Finished, Raw Material, In-Process and Packing etc.

Automatic on-line calculations for all test methods as per IP / BP / USP / in-house including titrations, dissolution, weight variation, content uniformity, UV, GC/ HPLC etc.

Automatic on-line calculations for more than 150 test methods as per IP / BP / USP / inhouse including titrations, dissolution, weight variation, content uniformity, UV, GC/ HPLC etc.

Work Assignments to the required chemists

Work Sheet Generation as per current specification

Multiple types of Sample Registrations like IP,FP,Packing etc.

Analysts can get their own work lists based on any priority with a click of the mouse.

Testing summary view or status view of analysis

Track samples from receipt, processing, testing and reporting

Options Like Reduced testing for Raw Material Samples

System supports generation of RDS/Work Sheet and COA Report after Review of Sample

Analyst Qualification to Qualify the New Analysts as per Individual Category(Sample Type)

Automatic calculations and certificate generation

Automatic Trend sheets and Graphs generation.

Retest , Recheck and other options

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