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Change Control Management Software – Globally Harmonized Change Control Process for Compliance & Quality

Overview

Pilgrim Software’s Change Management solution is an automated, harmonized change management process designed to improve an enterprise’s ability to implement changes in a compliant fashion across its sites, with transparency of the change information and the documentation to support them.

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Change control is critical to the operation of a manufacturer, particularly in the dynamically changing environment of regulated industries. Whether driven by FDA, EMEA or ISO regulations, companies are expected to establish change protocols.  Such procedures are tied to every part of the manufacturing process and to regulatory compliance as a way to improve product quality, effectiveness and safety.

However, managing change can pose a serious challenge due to insufficient support systems for helping organizations make informed decisions and quickly implement such changes. In addition, organizations must think of every possible element that might be affected by the change, and ensure that it is addressed. Lack of good and formal change management practices can lead to substantial compliance and operational risks and high associated costs resulting from lengthy implementation cycles or even product recalls and litigation.   


Companies need to simplify and automate the change control process by:

 

  • Tracking, documenting, and safely implementing planned, temporary and even emergency changes or deviations to company resources:
    • Assets such as equipment, facilities and utilities
    • Documents, policies, SOPs, specifications, design controls, formulations
    • IT/Computer systems and software
    • Processes, production, studies and laboratory controls
    • Products, parts, material, packaging/labeling, purchasing, contractors
    • Regulations and company policies
  • Identifying change categories, significance, impacts and justification
  • Defining tasks for initiators, approvers, implementers, and verifiers
  • Defining and enforcing the change process automatically
  • Initiating training from any changes
  • Verifying change and its effectiveness

Pilgrim’s Change Management solution includes:
  • Best Practices forms and workflow for Change Management
  • Ability to identify change categories and impacts
  • Risk Assessment and prioritization of change based on input data
  • Policy Management for automatic assignment and workflow selection
  • Automated Notification Triggers, Task Assignments and Escalations for overdue tasks
  • Highly configurable Review and Approval processes throughout Change Management workflow
  • Electronic Discussions to supplement change control meetings
  • Unlimited File Attachments for references/supporting documents
  • Corrective/Preventive Implementation Actions
  • Audit Trail and Electronic Signatures
  • Ad Hoc Query and Reporting
  • Integration with CAPA, Document and Training Management Applications


When used in conjunction with quality processes for Audit, CAPA, Document Management, and Training, Change Management software can not only help you solve problems today and help you detect problems in the future, but can be a powerful tool for performance monitoring and continuous improvement in the organization. Pilgrim’s Change Management software effectively manages change across the enterprise resulting in a more efficient organization and higher quality products and services.


Key Capabilities

Protecting Your Assets

With Pilgrim’s Change Management solution, companies can easily track and document, and safely implement planned, temporary and even emergency changes or deviations to company resources, including:

• assets such as equipment, facilities and utilities

• documents, policies, SOPs, specifications, design controls, formulations

• IT/Computer systems and software

• processes, production, studies and laboratory controls

• products, parts, material, packaging/labeling, purchasing, contractors

• regulations and company policies

 

Managing Change through Automation

Managing change among those resources can pose a serious challenge to organizations with insufficient support systems for informed decision-making and rapid implementation of the changes. In addition, organizations must think of every possible element that might be affected by the change, and ensure that it is addressed. Traditional paper-based, manual and ad-hoc approaches to change management are frequently error-ridden and unreliable, and data is frequently outdated before the appropriate individuals have been alerted to the changes. With Pilgrim’s Change Control solution, companies can simplify their change management process for increased efficiency and effectiveness through automation.

 

Visible Change

The real-time visibility provided by Pilgrim’s Change Control Management solution enables organizations to follow a structured methodology for each change request and track it through its lifecycle, from initiation through verification to closure. Whether your company prefers a 5-step change management process or a 6-step process, a single site-specific change or a change initiated at the corporate level with an impact assessment and action plan generation at each site, the Pilgrim solution provides your organization the required flexibility to configure the required change control process.

 

Efficient Change

Pilgrim’s Change Control Management solution enables companies to improve efficiency, increase control, and reduce risk by implementing a cohesive change management system. It provides enforcement of standardized change management procedures, powered by a configurable workflow engine that routes change records through the applicable impact assessment, review, approval, and implementation phases.

 

Enterprise-wide Change

When used in conjunction with Pilgrim’s quality processes for Audit, Corrective & Preventive Actions, Document Management, and Training, Change Control Management software can not only help you solve problems today and help you detect problems in the future, but can be a powerful tool for performance monitoring and continuous improvement in the organization. Pilgrim’s Change Management solution effectively manages change across the enterprise resulting in a more efficient organization and higher quality products and services.

 

 

Features & Benefits

Pilgrim Change Management -- Key Features & Benefits:

Capabilities

Benefits

Best Practices forms and workflow for Change Management

Reduces exposure to regulatory risk by enforcing SOPs, automating CAPA processes, streamlining audits and helping you ensure a qualified workforce

Risk Assessment and prioritization of change
based on input data

Reduces cycle times and variability by facilitating a "right first time" approach

Integration with Customer Complaints, CAPA,
Document and Training Management applications

Closed-loop process from customer facing and partner issues to manufacturing reduces risks of ineffective actions and provides early warnings

Ability to identify change categories and impacts

Provides visibilty across your value chain to quickly identify trends and take fast action

Automated Notification Triggers, Task Assignments
and Escalations for overdue tasks

Leverages existing technology investments to connect islands of information - ensuring the availability of timely, accurate data

Policy Management for automatic assignment
and workflow selection

Integrated technology platform to manage all compliance processes (variability, risks, visibility) for more consistent performance

Change Notification

Rapidly communicate changes to ensure that your entire organization is up to speed

Integration with Core Systems

Automatically enforce changes across all affected systems to ensure consistency

SmartDoc Integration

Ensures that changes affecting SOPs are automatically implemented

SmartTrain Integration

Automatically schedule training to educate your workforce about changes and new processes