Solutions
SmartAudit - Audit Management Software for Improved Performance and Guaranteed Compliance
By
Jul 30, 2005, 20:52

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 SmartAudit software solution enables companies to conduct ongoing internal audits and gain clear visibility into the effectiveness of organizational control mechanisms, so they can take fast, decisive action to reduce risk and ensure global compliance.

SmartAudit 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

Businesses can quickly organize effective audit programs that manage audit areas, schedules and criteria, thereby reducing time and labor costs.  Pilgrim’s Audit Management allows you to assign and manage audit teams and identify lead auditors. With SmartAudit Offline, audit can be conducted remotely; then teams at multiple sites can merge audit results in a single system by uploading the results to a centralized database, providing management with visibility into company performance.

Audit Schedule - click here to enlarge

SmartAudit Accelerates the Effectiveness of Audits

Streamlining the entire audit cycle allows organizations to create, schedule and perform audits faster than ever.  Electronic workflows ensure that findings, observations and action plans are reviewed and approved quickly. SmartAudit’s multiple search capabilities enable rapid location of audit data.

Audit Findings - click here to enlarge

SmartAudit Improves Quality Levels

With the establishment of a consistent process for documenting and categorizing audit findings, organizations can quickly issue findings to the appropriate areas for prompt resolution.  Follow-up audits enable quick measurement and effectiveness of an action plan.  Integration with Pilgrim's CAPA Management allows you to initiate detailed investigations and corrective and preventive actions. Follow-up audits enable you to measure the effectiveness of an action plan.

Audit Profile - click here to enlarge

SmartAudit Facilitates Compliance & Validation -- With role-based document securities, powerful password authentication, a complete audit trail and an easy, automated validation process, SmartAudit helps facilitate compliance with internal and industry standards and the regulatory requirements of: 21 CFR Part 11, FDA Parts 820, 210-211, 606, and 1270-1271; ISO 13485, 14001, and 9000; GMP, GLP, GCP; Sarbanes-Oxley (SOX); OSHA; EU, International Health Ministries; and more.

SmartAudit Supports Fast, Informed Decision-Making – Configurable reporting capabilities provide management with instant visibility into critical issues such as audit status, audit summaries and audit schedules, helping to identify trends for management to make the right decisions for their business.


Remote Audit Management Capabilities

SmartAudit 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 SmartAudit 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

Pilgrim’s Audit Management is a fully-integrated part of the SmartSolve® and Q&MIS® Integrated Compliance and Quality Platform. SmartSolve and Q&MIS provide an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external assessments, document control, SOP enforcement, employee certification and training, equipment/calibration and supplier quality 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.

For an overview of capabilities and benefits,click here.

More Information

• Discover in this free, informative webinar how you can ensure predictable quality by streamlining internal and external auditing processes
• Get more in-depth information in Pilgrim's SmartAudit datasheet
• Learn in this free white paper why your audit management solution should be part of an integrated compliance solution