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

• 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
  

Pareto Reports - click here to enlarge

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.


The Integrated Compliance Platform (Top)

Pilgrim’s SmartSolve® and Q&MIS® is a fully-integrated part of the Pilgrim Software’s Enterprise Compliance and Quality Platform. Pilgrim Software provides an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external audits, document control, SOP enforcement, engineering collaboration, employee certification and training, equipment/calibration, supplier quality management, advanced quality planning and risk management. This powerful solution enables you to manage quality and compliance across your entire business, helping you meet regulatory requirements, increase efficiency and reduce costs.