Quality Management System

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:-

SoftQMS – Deviation Management module designed to meet the latest FDA Quality system regulations ,MHRA as well as ICH Q10 guidelines.  It is an enterprise module where the organization can log all deviations or non conformances  in SoftQMS.

Soft QMS- Deviation Management System module is an effective tool to  find out the root cause of the deviations or nonconformances in the organization and ensures continual improvemnt is undertaken in a timely and effective manner.

Soft QMS  -Deviation Management System Soft QMS – Deviation Management  has been designed to meet the following minimum stages of Deviation or Nonconformance  management process  but not limited to

1. Initiation or proposing  a deviation or nonconformance with reason
2. Summary of  Impact due to deviation or nonconformance
3. Decision on the investigation & Root Cause Analysis
4. Proposing immediate corrective action and CAPA
5. Closing a Deviation

The following are the major benefits for the Deviation or Nonconformance Management System

• Easy tracking of all Deviations initiated in the organization
• Action items with proposed timelines
• Alerts and reminders for the activity
• Summary and Trends of Deviations any time
• Deviation management allows the organization to assess the overall impact of a change
• Compare & control the number of deviations raised for same product or system
• Increased customer service and effective service to clients from confident and knowledgeable employees
• An effective deviation management process lowers the risk associated with process

Market Complaint  Management System :-

SoftQMS – Market Complaint Management module designed to meet the latest FDA Quality system regulations ,MHRA as well as ICH Q10 guidelines.  It is an enterprise module where the organization can log all deviations or non conformances  in SoftQMS.

Soft QMS- Market Complaint Management module is an effective tool to  find out the root cause of the deviations or non conformances in the organization and ensures continual improvement is undertaken in a timely and effective manner.

Soft QMS  - Market Complaint Management Soft has been designed to meet the following minimum stages to handle market complaint  management process  but not limited to

1. Registering a Complaint  with reason and Source
2. Summary of Market Complaint
3. Review of Immediate impact & Immediate corrective action
4. Decision on the investigation & Root Cause Analysis
5. Proposal of CAPA
6. Closing a Market Compliant

The following are the major benefits for the Market Complaint Management System

1. Easy tracking of all Market Complaints initiated in the organization
2. Action items with proposed timelines
3. Alerts and reminders for the activity
4. Summary and Trends of Market Complaints any time
5. Complaint management allows the organization to assess the overall impact of a change
6. Increased customer service and effective service to clients from confident and knowledgeable employees
7. An effective Complaint management process lowers the risk associated with process

Introduction to CAPA

The pharmaceutical company should have a system for implementing corrective actions and preventive actions resulting from the investigation of complaints, product rejections, nonconformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. A structured approach to the 10 investigation process should be used with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9. CAPA methodology should result in product and process improvements and enhanced product and process understanding. soft QMS – CAPA Management has been designed to meet the following minimum stages of CAPA management process but not limited to

1. Initiation or proposing  a CAPA  with a cause or reason
2. CAPA Review
3. CAPA initiation based on the different types of requirements
4. Decision on the investigation & Root Cause Analysis
5. Implementation of CAPA
6. CAPA Approval
7. Effectiveness Check
8. CAPA final closing