Audit Management Software - Manage Governance, Compliance and Risk with Internal & External Audits

Overview

Pilgrim’s Audit Management solution is a powerful auditing solution that helps organizations assess their state of compliance. This integrated solution provides all the tools you need to benchmark your and your suppliers’ performance against internal, industry and regulatory requirements. With Audit Management, you gain clear visibility into the effectiveness of your organizational control mechanisms, so you can take fast, decisive action to reduce risk and ensure global compliance.

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Managing governance, compliance and risk is a top priority for manufacturers and Life Science companies, especially when confronted with unscheduled external audits or unexpected regulatory investigations. Pilgrim's Audit solution allows for scheduling, performing and following up on any type of quality audit including supplier and third-party audits, including GMP/GCP/GLP, EH&S, contractor, risk assessment, internal controls, and others.

Tasks made easy include:

Benchmarking company and supplier performance
Handling audit findings that require corrective actions
Performing company audits in less time with reduced labor
Achieving compliance with industry and regulatory requirements

Key Capabilities

Improve Audit Efficiency & Reduce Cost

Audit Management enables you to quickly organize effective audit programs. You can set-up programs to manage audit areas, schedules and checklists – reducing time and labor costs throughout the auditing process. Audit Management also allows you to assign and manage audit teams and identify lead auditors. Pilgrim’s Audit Management Offline enables you to perform remote audits, including mobile field audits, while disconnected from the network. After the audit is complete you can leave an initial summary report with the auditee and upload the audit results to the centralized database. This enables teams at multiple sites to merge audit results in a single system – providing management with visibility into company performance.

Accelerate the Effectiveness of Audits

Pilgrim’s Audit Management enables you to streamline the entire audit cycle, allowing you to create, schedule and perform audits faster than ever before. Electronic workflows, with escalation capabilities, ensure that findings, observations and action plans are reviewed and approved quickly. Multiple search capabilities enable you to rapidly locate audit data. E-mail notification and the SmartSolve “Things-to-Do List” provide everyone in the organization with fast access to pending tasks and new information.

Improve Quality Levels

Audit Management enables you to establish a consistent process for documenting and categorizing auditing findings. This helps you to quickly issue findings to the appropriate people, departments and organizations for prompt resolution. With Audit Management, you can create and attach action plans based on audit findings. Integration with Pilgrim’s CAPA Management solution allows you to initiate detailed investigations and corrective and preventive actions. Follow-up audits enable you to measure the effectiveness of an action plan. With Audit Word Report, auditors can quickly generate a final audit summary report to be distributed to all parties involved with the audit.

Security and Regulatory Requirements

With role-based securities and powerful password authentication, Inspection Management will ensure the security of your data without the heavy administrative burden associated with individual user security. A complete audit trail, combined with electronic signature and electronic records, facilitates compliance with 21 CFR Part 11.

Support Fast, Informed Decision-Making

Audit Management’s configurable reporting capabilities provide management with instant visibility into critical issues such as audit exception status, audit summaries and audit schedules. Custom reports can also be created for use throughout the organization. Audit Management provides you with early detection of problem areas and helps you identify trends so that you can make the right decisions for your business.

Remote Audit Management Capabilities

Pilgrim's Audit Offline allows the solution’s users to edit internal and external audits without access to a server or database. Audits can be checked out of the Audit software and downloaded to a local auditor’s laptop. This allows the auditor to:

Delegate to other audit team members
Take the electronic audit record to the auditee site
Edit the audit record off-site
Respond to the sections and questions in an audit record offline
Manage audit notes offline
Leave initial summary report with the auditee
Merge and upload results

The Integrated Compliance & Quality Platform

Pilgrim Software supports your organization’s quality and compliance processes with SmartSolve®, its fully integrated enterprise platform for managing corrective and preventive actions, nonconformances, customer complaints, SOPs and regulatory documents, training and certifications, and audits. This powerful and comprehensive closed-loop solution integrates and streamlines quality and compliance processes across your entire business - helping you meet industry and regulatory requirements, increase efficiency and reduce costs.

Features & Benefits

Capabilities	Benefits
Reduce the Risk of Noncompliance
Audit Library	Benchmark performance against industry and regulatory criteria
Custom/Hybrid Checklists	Ensure that your company meets corporate governance and internal requirements
Inherit Policies	Enforce standards by enabling sites to inherit corporate policies and workflows
Electronic Sign-off	Electronically sign-off on audit segments to meet 21 CFR Part 11 requirements
Improve Audit Efficiency and Reduce Cost
Audit Types	Use pre-defined values to eliminate manual data entry
Audit Programs	Reduce schedule conflicts and ensure that audits are done correctly and on time
Online Notes Editing	Streamline audit summaries by editing findings and observations through a single interface
Audit Response	Immediately trigger corrective actions to resolve issues rapidly
Attach Evidence	Quickly corroborate findings by storing evidence with audit results in a central location
Off-line Audits	Streamline offsite audits and enable collaboration between audit teams
Accelerate the Effectiveness of Audits
Audit Lifecycle Workflow	Reduce time-to-audit by establishing enterprisewide best auditing practices and workflows
Review & Approval Models	Establish enterprise-wide models for audit review and approval to promote consistency
Search	Flexible search capabilities enable you to rapidly find the information you need
Things-to-Do List	Keep your entire organization up-to-date about schedules, programs and action plans
E-mail Notification	Provide task notification to ensure that items are completed on schedule
Share Results	Promote continuous improvement by sharing audit results across sites
Improve Quality Levels
Create Action Plans	Quickly roll out action plans to initiate immediate improvement
Track Corrective Actions	Track the status of action plans to ensure that they are carried out effectively
Ad Hoc Audits	Perform unscheduled audits to address immediate issues
Follow-up Audits	Perform follow-up audits to ensure action plan effectiveness and compliance
Audit Word Report	Easily generate consistent audit summary reports showing key information from the audit