Compliance

TMS Quality Compliance Software is designed to automate and simplify the entire Quality Management process.  Quality and Compliance is the focus of TMS, which provides the framework to ensure customers achieve a high level of quality as well as maintain compliance for those in highly-regulated industries.  This is essential for helping companies produce consistent, quality products and services, which in turn brings many business benefits.

With TMS, Quality Managers really do Work Smarter, Not Harder.  That means….

  • Compliance to Industry Standards and Regulations (e.g. FDA, ISO, OSHA)
  • Audit-Readiness simplified with Audit Trails and Reports
  • Document Collaboration with Approvals and Review Cycles
  • Task Action Items with Auto-Notification, Routing, and Escalation
  • Training Management confirms Employees are Qualified and Competent
  • Electronic Signatures with Date & Time Stamp (21 CFR Part 11 Compliant)
  • Secure and Protected Access to Documents based on Permissions
  • Streamlined Organizational Processes with Automated Workflows

Audit Management

TMS Quality Compliance Software can help you manage and simplify audits whether they are Internal, Customer/Supplier or Regulatory.   From start to finish, it ensures audit preparedness by providing a streamlined process for all of your audit-related activities (i.e. audit plans, checklists, data collection, audit reports, recommendations and responses).  

TMS helps manage audits, risk and compliance:

  • Centralized Documents (ensures latest versions of policies and procedures are in use)
  • Data Security (robust security options with access control based on permissions)
  • Document Searching (comprehensive search tools allow you to find data immediately)
  • Automatic Notification (notifies personnel of tasks for improved workflow and efficiency)
  • Audit Trails (provide increased visibility that details actions taken, when and by whom)
  • Built-In Reports (Run reports with a single click and print or export in various file formats)

FDA 21 CFR Part 11 (Electronic Records;Electronic Signatures)

TMS is designed to satisfy the requirements for Electronic Records and Signatures, ensuring compliance with the Food and Drug Administration (FDA) regulations for 21 CFR Part 11.

TMS addresses the following key areas:

  • Records Management (Accurate and Readily Retrievable)
  • Document Management (Revision and Change Control)
  • Training Management (Job Training and Certifications)
  • System Security (Authorized and Permission Based Access)
  • Secure Audit Trails (Confirms the Integrity of Records)
  • Electronic Signatures with Date/Time Stamp (Trustworthy & Reliable)
  • System Validation (Certifies Consistency and Reliability)

FDA GxP (GMP, GLP, GCP)

TMS assists those companies who operate in highly-regulated industries with achieving and maintaining continuous compliance with GxP regulations.

TMS provides:

  • Streamlined Workflows (manage processes from implementation to finish)
  • Audit Trails & Reports (efficiently prepare for inspections and execute audits)
  • Controlled Documents (essential documents readily available and accessible via permissions)
  • Good Documentation Practices (ensures accuracy, completeness, consistency and reliability)
  • Employee Training (certifies responsible workforce is trained and qualified with defined roles)
  • Change Control (data revisions with traceability and review/approval signatures)
  • Electronic Signatures (captures date and time stamp and adheres to 21 CFR Part 11)

FDA FSMA (Food Safety Modernization ACT)

Food manufacturers, processors, transporters and distributors are affected by the FSMA regulations.  It is more important than ever to adopt well-documented processes to ensure compliance with FSMA requirements.  Failure to provide requested records during an audit can result in anything from litigation and fines to suspension of a facility’s FDA registration.

TMS delivers:

  • Complete Documentation (critical records and food safety plans are readily available)
  • Automated Workflows (implement and manage corrective actions and preventive controls)
  • Training Records (ensures and documents the required training for qualified individuals)
  • Change Control (tracks data changes with a detailed history and review/approval signatures)
  • Audit Trails & Reports (provides traceability for quality inspections and compliance audits)
  • 21 CFR Part 11 Compliant (electronic signatures are authenticated and attached to records)
  • Secure Centralized Repository (enforces data security with permission-based access to data )

ISO Standards

TMS helps to ensure conformance with the ever-evolving quality system requirements of ISO Standards (e.g. ISO 9001; ISO 14001; ISO 17025; ISO 31000).

TMS facilitates compliance with the following features:

  • Document Control (for managing SOPs; Quality Manuals; Records; Specs; CAPAs)
  • Training Management (with Quizzing and Certification; Job Planning; Job Deviations)
  • Change Control (Review and Approval; Electronic Signatures; Time & Date Stamps)
  • Audit Trails and Reports (respond quickly to regulatory information requests)
  • Supplier Management (external access to documents with secure log-ins)
  • Risk Assessment Tool (graph calculates probability risk  and severity)

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