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Pharma Soft Sol

Hyderabad, Telangana

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Management System Software Solutions

Prominent & Leading Service Provider from Hyderabad, we offer Quality Management System Software Solutions, Document Management System - SoftDMS Software Solutions, Vendor Management System- VM Software Solutions, Quality Risk Management System Software Solutions, Product Qualty Review - PQR Software Solutions and Breakdown Maintenance Management System Software Solutions.

Quality Management System Software Solutions
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Introduction:
A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Of all QMS regimes, Pharma Soft Sol Quality Management System Software deals with quality and sustainability and their integration.

Pharma Soft Sol’s softQMS can be used for many reasons, including the management of compliance, facilitating the investigation of adverse events and the proceeding corrective actions, managing risk, and, among many others, integrating complaint management into the quality management process. softQMS is in line with International Conference on Harmonization (ICH) guidance like ICH Q10 Pharmaceutical Quality System, ICH Q9 Quality Risk Management, and with WHO, FDA and EU requirements. softQMS helps organization to design, implementation, monitoring, and maintenance of an effective pharmaceutical quality system. softQMS is an integrated software and structured to work harmoniously as a single quality system for organizations.
Pharma Soft Sol softQMS Software included with the following modules but not limited to
  •  Change Management
  •   Deviations or Non conformance Management
  •   Market Complaints Corrective Action and Preventive Action Management
  • Quality Risk Management
  • Audit Management
  •  Vendor Management

CHANGE MANAGEMENT  or  CHANGE CONTROL :
softQMS – Change Management module designed to meet the latest FDA,MHRA Quality system regulations as well as ICH Q10 guidelines.  It is an enterprise module where the organization can log all change controls with softQMS.

softQMS- Change management module is an effective change management system to  evaluate, approve, and implement the changes properly.

softQMS- Change management system ensures continual improvement is undertaken in a timely and effective manner.

softQMS - Change management has been designed to meet the following minimum stages of change control but not limited to

  1.   Initiation or proposing  a Change with reason
  2.   Summary of Impact due to change
  3.   Decision on Change proposed
  4.   Implementing a Change
  5.   Closing a Change Control

The following are the major benefits for the Change Control Management System
  •     Easy tracking of all Change Control in the organization
  •     Action items with proposed timelines
  •     Alerts and reminders for the activity
  •     Summary and Trends of CC’s any time
  •     Change management allows the organization to assess the overall impact of a change
  •     Change can be implemented without negatively effecting the day to day running of business
  •     The time needed to implement change can be reduced
  •     The possibility of unsuccessful change can be reduced
  •     Employee performance increases when staff feel supported and understand the change process
  •     Increased customer service and effective service to clients from confident and knowledgeable employees
  •     An effective change management process lowers the risk associated with change
  •     Managed costs of change: change management helps to contain costs associated with the change.
Deviation Management System  or Process Non Conformance  or Material Non Conformance Management System:-

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Document Management System - SoftDMS Software Solutions
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Pharmaceutical and Biotech companies are challenged to meet control documentation requirements in day to day operations.Effective document management and document control are critical parts to any quality and compliance solution. Global Regulatory agencies expects that all regulated companies follow current industry best practices throughout the manufacturing process. To meet these requirements Phama Soft Sol developed Document Management System software which helps to control and distribute the SOP's , STP's and other regulated documents.

Document management software systems not only reduce the costs of compliance, but also help you improve process and product quality. Document Management System(softDMS) able to retrieve the information you need-exactly when you need it-minimizes the possibility of miscommunication and mistakes which in turn minimize risks, manhours and other documentation errors.

Document Management System software is also an easy tool to control the documents for sharing and retrieval at the same time safeguarding the Document Management System at a low cost.In other words, having the right documentation available at the right time will save organization's time and money.
Document Management – Features
Document Initiation and Approval
E-Mail Alerts and Notifications
Approval of Document and training
Document Master List View and Document Search
Master Lists and Documents can be viewed by the authorized users.
Distribution of Documents, Print at Department Level
Current Version Availability
Tracking and Reminder for Revision
Revision Control
Approved Document Search:
Find Document:
Audit Trails
Security to the Documents
Controlled Document Access
Integrates with Other Applications
Benefits to the Document Controller
Handle many document’s at a time & Status view
Automates document review and approvals as a paperless solution
Email alerts for each document revision dues and over dues
Select the document initiators , reviewers and approvers online
Auto updating of Master Lists
Share document’s online
Print document’s at department level
Benefits User
Save Time
Data in Your Possession
E-Mail Alerts for the required activities
Review the document any time and in any place
Documentation Status and availability
Online Document view

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Vendor Management System- VM Software Solutions
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 All the vendors of the products shall be evaluated and qualified right from the stage of product development to finished product manufacturing of the product. The pharmaceutical company is ultimately responsible to ensure processes are in place to assure the control of outsourced activities and quality of purchased materials.

These processes should incorporate vendor management and include:

(a) Assessing prior to outsourcing operations or selecting material suppliers, the suitability and competence of the other party to carry out the activity or provide the material using a defined supply chain (e.g., audits, material evaluations, qualification).

(b) Defining the responsibilities and communication processes in a written agreement between the contract giver and contract acceptor.

(c) Monitoring and review of the performance of the contract acceptor or the quality of the material from the provider, and the identification and implementation of any essential improvements.

(d) Monitoring incoming ingredients and materials to ensure they are from approved sources using the agreed supply chain.

In order to meet these requirements Pharma Soft Sol developed vendor management system software to organize the detailed vendor management process that includes development, qualification & re requalification of vendors.

Advantages of Vendor Management System Software–

Approved Vendor List online

Maintain Audit Schedules online

E-Mail Alerts and Notifications

Automatic requalification schedule population

Vendor evaluation with required check lists

Categorization vendor audits

Track vendor audit progress

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Quality Risk Management System Software Solutions
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Introduction:
It is important that product quality should be maintained throughout the product lifecycle. In the earlier days risk was assessed by check lists, trends, flowcharts etc. Now the risk management approach initiated by regulatory agencies with recognized management tools along with support of software .

Inview of the above Pharma Soft Sol is designed QRM module to perform the Risk ManagementPharma Soft Sol QRM software solution can be used to assess risks and monitor the effectiveness of risk mitigation activities. Various risks across the organization can be visualized and the same can be linked to business units, projects, goals or processes.
Advantages of QRM Software:
  1.     Risk Dash boards
  2.     Risk assessment process based on the requirement
  3.     Automatic RPN calculation
  4.     Risk mitigation reviews online
  5.     Action items generation
  6.     Automated mail communications

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Product Qualty Review - PQR Software Solutions
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Regular periodic or rolling quality reviews of all registered pharmaceutical products, including export only products, should be conducted to highlight any overall trends and to identify product/process improvements by verifying and identifying
  • The consistency of the existing process(es)
  • Trends in product data
  • The appropriateness of current specifications for starting materials, intermediates and finished products
  • Deficiencies not detected by routine testing, monitoring or performance metrics
  • Identify opportunities for product and process improvements
In view of the above requirement Pharma Soft Sol designed - PQR software to meet the latest requlatory and industry Product Quality Review requirements.
Advantages of PQR

Online approvals, Notifications and Status view

Online view of PQR status

Online product data entry

Product wise identification of issues or trends

Product summary of findings, conclusions and recommendations

Online approvals, Notifications and Status view

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Breakdown Maintenance Management System Software Solutions
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Breakdown maintenance is very critical in pharma industry as the equipment that has malfunctioned and is unusable in turn effects the quality of the product.

Breakdown management system software is designed to safeguard your equipment management and continued compliance with automated preventative maintenance programs and engineering service requests.

Advantages:-

Initiate the breakdown information in the application to the required user and user department.

Mail notifications and alerts to the concerned about breakdown immediately once the breakdown is initiated.

Required process flow to address different types of issues or breakdown.

Corrective action and work assignments thorough software.

Breakdown categorization and workgroups creation.

Automatic equipment log updation

Communication to CAPA if required.

Comply with user and regulatory requirements.

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Validation Management System Software Solutions
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Performing validation to Equipments maintaining the schedules are critical to the Pharma Industry in order to produce quality products as well as to meet the cGMP.

Performing the validation without missing timeline for a single equipment within the its due date is a great challenge to the industry. To meet these requirements Pharma Soft Sol designed validation management software.

FEATURES - VALIDATION MANAGEMENT

Equipment Registration

All equipments required calibration in the organization or plant can be included in the software with auto generated number or existing manual numbers

Planning and Scheduling for Validation

Equipment validation can be planned like yearly and adhoc. The required schedules can be done in the software.

E-Mail Notifications for Validation activity

Auto generated email notifications will be sent with an alert date as well as due date for validation well in advance to the users, supervisors, Dept In charges and to other department users  to plan for the activity without  overlapping the hectic  production and maintenance schedules

 Performance Management of Validation

Pie Chart view is available for the senior level users to know the overall status of the validations

MIS Reports

Management Information Reports are generated automatically for online status and it will be generated as a pdf copy.

Advantages:-

  •     Comply with all regulatory requirements like 21 CFR Part11, Annexure 11 of MHRA & GAMP-5
  •     Scalable to Plant or Enterprise wise installation and use
  •     Automatic Notifications to ALL USERS
  •     Work Assignments to the required personnel
  •     Automatic generation of Yearly Schedule
  •     Automatic Tracking Status
  •     Online Approvals of Results
  •     Online access from any where

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Report Generation System
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Report Generation System

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Pharmaceutical industry use multiple equipments for their operational use. Some of the installed equipment may not have the reporting system inbuilt with the equipment or supplier don’t have the software like SCADA and report generation. Some times these equipments might be installed with a stand alone computer.

In such instances and to integrate all equipments data in to one place, Pharma Soft Sol developed report generation system. By using this software these reports can be viewed with any web browser from any computer. The data or reports are secure with required controls as part of the data security and regulatory requirements. The reports are customizable and can be used for regular operational use.

Report Management are generated automatically from each connected equipment. For online status the user can check the reports in web browser and for operational use the reports can be generated as a pdf copy.

Advantages

Access equipment data like log records, operation details, batch usage details online

Automatic equipment usage hours online

Safe storage equipment data in a centralized server

Automatic trending to the selected parameters

Comply with all regulatory requirements like 21 CFR Part11, Annexure 11 of MHRA & GAMP-5

Automatic Tracking Status

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CalPM Software Solutions
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CalPM Software Solutions

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Performing calibration for Instruments and Preventive Maintenance for Equipments maintaining the calibration and Preventive Maintenance data base are critical to the Pharma Industry in order to produce quality products as well as to meet the cGMP.

Performing the calibration and PM activity online without missing timeline for a single instrument or equipment within the its due date is a great challenge to the industry. To meet these type of requirements Pharma Soft Sol designed CalPM software.
CalPM Software can be installed directly in the company server and used as an online software solution. Users can login from any computer in the LAN or in web browser without usual problems resulting from application software, location or PC compatibility.

FEATURES - CALIBRATION

Instrument Registration

All instruments required calibration in the organization or plant can be included in the software with auto generated number or existing manual numbers

Planning and Scheduling for Calibration

 Instruments  calibration can be planned  in schedule. The required schedules can be done in the software.

E-Mail Notifications for Calibration activity

Auto generated email notifications will be sent with an alert date as well as due date for calibration well in advance to the users, supervisors, Dept In charges and to other department users  to plan for the activity without  overlapping the hectic  production and maintenance schedules

Work Sheet generation for calibration

Work sheet will be generated for the user who is planned to perform the calibration activity on the day of calibration .

 Calibration Data Entry and Results evaluation

Calibrated readings can be entered for data evaluation and report approval. Different units of measurements for a single parameter can be evaluated automatically  to meet with the standard parameters

Certificate Generation for the calibration completed instruments

Calibration label and certificate will be generated after completion of the evaluation of the results.

Trend for the completed calibrations

Different trends for each instrument is available for proper analysis of the results

 Performance Management of Calibration

Pie Chart view is available for the senior level users to know the overall status of the calibrations
FEATURES – PREVENTIVE MAINTENANCE

Registration & PM Check List  to the Equipment Preventive Maintenance

All Equipments  required Preventive Maintenance  in the organization or plant can be included in the software with an auto generated number or existing manual numbers. All types of PM checklist for the activity like Daily, Weekly, Fortnightly, Monthly, Quarterly,  Half-Yearly and Yearly Checklists can be generated in the software

PM Scheduler E-Mail Notifications

PM Schedule to created based on the plant level requirements for the year

Work Sheet generation for the user for PM

Work sheet will be generated for the required user to perform the PM activity on the day of activity

PM Check List  Results Approval

The completed checklist can be sent for approval process and status approval

 Performance Management

Pie Chart view is available for the senior level users to know the overall status of the calibrations

MIS Reports

Management Information Reports are generated automatically for online status and it will be generated as a pdf copy.

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Equipment Data Integration Software Solutions
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A Data integration system is an automated information system that connects, monitors and display the complex manufacturing data and data flows in the manufacturing plant. It is an effective tool to acquire the data automatically from installed automated systems for improving and optimizing the manufacturing process to the organization. By using Pharma Soft Sol Data Integration System Software the company or plant can digitalize the manufacturing processes and integrate various equipments operations in the shop floor.

Data Integration- Advantages

Avoids data integrity issues to data recording

Scalable to any process requirements with out effecting the regular schedules

Avoid manual data entry and data transfer

Reduces manufacturing cycle time and lead time to batch completion

Reduces or eliminates data entry time and reduce paper work

Improves product quality and add value to batch manufacturing process

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Manufacturing Execution System Software Solutions
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A manufacturing execution system (MES) is an information system that connects, monitors and controls complex manufacturing systems and data flows in the manufacturing plant. It is an effective tool with batch manufacturing details and data entry or acquiring automatically from installed automated systems for improving and optimizing the manufacturing process to the organization. By using Pharma Soft Sol MES the company or plant can digitalize the manufacturing processes and integrate various equipments operations in the shopfloor.
Manufacturing Execution System – Advantages
  • Scalable to Plant or Enterprise wise installation and use
  • Automatic Notifications to ALL USERS
  • Work Assignments to the required personnel
  • Automatic Tracking Status
  • Online Approvals of PM Checklist
  • Online access from any where

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Softbmr  Electronic Batch Record Management System Software Solutions
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Batch Records preparation, Approval, issuance, recording of Batch manufacturing details, maintenance of the batch data and archival of records are very critical to Pharma Industry in order to produce quality products as well as to meet cGMP. This can be easily achieved through Pharma Soft Sol’s Electronic Batch Record Management System Software (softBMR).

SoftBMR - Batch Record Management System Software is specially designed software to meet the Good Documentation and Manufacturing Practices in Pharma and Biotech Industries. When compare with other online Electronic BMR Management solutions Pharma Soft Sol’s - softBMR exactly meets the current Pharma and Biotech industry manufacturing requirements and procedures.

softBMR is specially designed software to meet the product specific and company specific requirement with a unique number and product code registration for each record and also to meet all operational requirements for Batch manufacturing. The requirements for different formulations and different process flow requirement are inbuilt in the software. In a total the softBMR exactly meets the current automated Batch Record Management system approval and execution management.

softBMR can be installed directly in the company server and used as an online software solution. Users can login from any computer in the LAN or in web browser without usual problems resulting from application software, location or PC compatibility.

softBMR – Features

BMR initiation and Approval

New BMRs and change BMRs can be initiated for review and approval. The comments during review can be given in the software by reviewers and approvers as reviewers comments.

E-Mail Alerts and Notifications

E-mail and Notifications will be populated automatically to the required users for each stage during the initiation, review and approval of a BMR

BMR Master List View and BMR Search

Master Lists of BMR can be viewed by the authorized users.

In Master list of BMRs Status View like Number of approved BMRs, Pending for approval and revision etc. can be seen online.

Execution of BMR at Department Level

The approved BMRs can be requested online as Manufacturing Request for regular batch manufacturing. The manufacturing request can be approved by the designated approver to initiate the Batch Manufacturing Execution.

Benefits by using softBMR -

Handle many BMR’s and BPR’S at a time & Status view

Automates BMR & BPR review and approvals as a paperless solution

Email alerts for each BMR & BPR review and approvals

Select the BMR& BPR initiators, reviewers and approvers online

Auto updating of Master Lists

Share BMR’s & BPRS’s online

Benefits to the Production for Execution of the BMR ‘s & BPR’s-

BMR & BPR Execution Request, review and approval online

BMR & BPR Execution is online

BMR & BPR manufacturing history with reports online

E-Mail Alerts for the required activities

Review the BMR & BPR any time and in any place

BMR & BPR Status and availability

Online BMR & BPR view

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E-Log Management System Software Solutions
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requirementsMaintaining an equipment logbook is a mandatory as per FDA 21 CFR 211.182 Equipment cleaning and use log requirements. Equipment Log Management (ELOG) is one of the essential elements of a quality management system. Proper log management of the equipment in the organization is necessary to ensure accurate, reliable, and timely manufacturing details of products

The E-LOG software is a Web-based application specifically deals with the requirements related to the Equipment Usage ,Cleaning, calibration and other details Log for all equipments. E-Log Management helps organization to enter the usage details of each & every equipment or instrument in a GMP manufacturing environment.The Equipment use log can be included with automatic date, time, product, and lot number of each batch processed.

The entered details or logs can be verified and reviewed through approval workflows. The system allows end users to design equipment log forms as per approved SOPs. Any type of form can be created for the equipment based on the user requirement.
E-Log Management System – Advantages
  • Manage Batch manufacturing time recording online
  • Maintain Equipment and Usage Logs Cleaning
  • Maintain Calibration, Inspection and Maintenance Logs of Equipments
  • Print, View and Export Equipment Logs to different File Formats
    Alerts and Notifications

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BMR Issuance - Batch Record Issuance Management Software Solutions System
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BRIMS- Batch Issuance Record Management System Software is designed to meet the Good Documentation and Issuance Practices in Pharma and Biotech Industries. When compare with other online BMR Issuance Management solutions Pharma Soft Sol’s - BRIMS exactly meets the current Pharma and Biotech industry Batch Record Issuance maintenance requirements and procedures. By using BRIMS the BMR can be printed with a unique number to each record generation and required print details on the BMR/BPR. The requirements for different formulations and different process flow requirement are inbuilt in the software. In a total the BRIMS exactly meets the current Batch Record Issuance and approval process . BRIMS can be installed directly in the company server and used as an online software solution. Users can login from any computer in the LAN or in web browser without usual problems resulting from application software, location or PC compatibility.
BRIMS - Main Features
  • BMR/BPR request initiation and Approval
  • E-Mail Alerts and Notifications
  • Issuance of BMR, Print at Department Level
  • BMR Retrieval
Benefits to the Document Controller
  • Handle many BMR’s and BPR’S at a time & Status view
  • Automates BMR & BPR issuance as a paperless solution
  • BMR & BPR Issuance Request, review and approval online
  • BMR & BPR Issuance Request with print details can be automatic
  • BMR & BPR Issuance history with reports online

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Learning or Training Management System Software Solutions
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Training or Learning in Pharma Industry varies from the regular training as it requires different trainings as per their operations and GMP.

Pharma Soft Sol Learning Management System (LMS) is a specially designed Software for Employee Training required in the Pharma and Biotech industry. Pharma Soft Sol's LMS is easy-to-implement software to all types of Trainings in the company and designed to ease the training requirements without spending too much time and resources. The Learning Management System enables you to schedule, track and report on employee training, Schedules, certifications and qualification for individual employees or workgroups. It gives you complete, real-time visibility into the performance of your training program.

Existing or Manual System
Volume of Trainings:-

The more employees you need to train, the harder it is to track. This is especially true if trainees work different shifts in different locations, or if employees need to undergo different types of training simultaneously. For most companies, training usually means retraining because it’s a requirement that has to be fulfilled on a regular basis.

Communication for Trainings:-

Tracking calls for two-way communication. The training coordinator needs to inform all trainees about their tasks. Just as important, trainees need to communicate back upon completion of training. And in between, there’s a need to remind people or escalate tasks. Paper-based and hybrid systems create unnecessary added work with uncoordinated e-mail messages, phone calls, and face-to-face communication that are difficult to track.

Revision and Updations of Systems:-

Changes made to key processes almost always trigger modifications to design, SOP, or work instruction documentation. For each change, retraining must be performed and documented. Disconnected change control and training systems in paper-based or hybrid environments are extremely error-prone and labor-intensive.

Training Records and Data Retrieval:-

Tracking training events, generating reports for till date completed trainings require lot of manpower and man hours. During regulatory inspections and other requirements it is not only a time taking process also a challenge to the organization.

About LMS Software:-

Managing total training requirements through software will have a great advantage when compare to manual process.

In view of the above Pharma Soft sol designed LMS (Learning Management Solution) to provide online training to all employees without missing a single training event.

The LMS  or Training Management  System help you execute, document, track, and manage all your training requirements in a timely and cost-effective manner. This software is flexible, allowing you to create and deploy a variety of simple or extensive training courses that require users to learn their tasks and demonstrate competency.

 LMS is a Webbased application making it easy for onsite and offsite employees to complete training tasks virtually anywhere.

LMS can be linked with other modules like Document Management System and other QMS Softwares.

Benefits

Here are some of benefits of the Learning Management System.

1. Scheduling for yearly training schedule based on all departments’ requirements.
2. Send automated alerts to employees required to complete training.
3. Send alerts for pending and overdue training requirements to employees and supervisors.
4. Track training requirements and progress at multiple levels including: employee, job title, work group, department, division, facility, and location.
5. Report on training by course, employee, job title, work group, division, location, year and more.

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Quality Management System QMS Software
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