TMS Quality Compliance Software is designed to automate and simplify the entire Quality Management process. Quality and Compliance are the focus of TMS, which provides the framework that helps customers achieve a high level of quality and maintain compliance requirements to standards such as FDA, ISO, GxP, OSHA, and SOX. This is essential in order for companies to consistently produce high quality products and services, which in turn brings many business benefits.
With TMS, companies improve profits and reduce tedious compliance tasks:
- Audit Trails and Reports Simplify and Reduce Audit Preparation Time
- Document Control Provides Data Integrity and Quick Access to Information
- Permission-Based Access Protects Documents from Unauthorized Use
- Automated Workflows Streamline, Manage and Track Business Processes
- Task Items with Auto-Notification, Routing and Escalation Ensure Accountability
- Dashboards and Graphs Provide Data Analytics and Insight to Gauge Risk
- Training Management verifies Employee Competence and Qualification
- Electronic Signatures with Date & Time Stamp is 21 CFR Part 11 Compliant
- Closed loop integration between many of the processes reducing redundancy
TMS Quality Compliance Software is the ideal audit management solution for ensuring your organization’s preparedness for audits whether they are Internal, Customer/Supplier or Regulatory.
From start to finish, TMS simplifies processes and makes it easy to manage all aspects of your audit-related data, tasks, and activities (i.e. audit plans, checklists, data collection, audit reports, findings, recommendations and responses).
TMS is a Smarter Way to Manage Audits and Minimize the Risk of Non-Compliance:
- Manage numerous findings for ease of follow-up
- Automatic reminders when action items are not completed on time
- Schedule follow-up reminders for closing out audits
- E-Notifications with Escalation notifies personnel of tasks and critical deadlines
- Audit Trails optimize visibility with details of actions taken, when and by whom
- Reduction of paperwork saves time, money and resources
- Instant access to audit information
- Flexible workflows for creating audit practices
FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
TMS Software is 100-percent compliant with FDA’s 21 CFR Part 11 regulations for Electronic Records and Electronic Signatures. TMS provides technical controls that meet the regulatory requirements for electronic records and electronic signatures to be trustworthy, reliable, and essentially equivalent to paper records and handwritten signatures:
- System Security and Access control requires two distinct identification components (user name and password).
- Document Integrity ensured through the inclusion of Verified and Secure Signatures of Authorized Content Authors, Reviewers and Approvers. Only authorized individuals can use the system and electronically sign a record. System Security determines authorized individuals by checking access and permission rights.
- Signed Electronic Records contain the name of the signer, date and time of signing, and meaning associated with the signature (i.e. acknowledgement, review, approval, or authorship). Once an electronic signature is linked to a specific record, the signature cannot be modified, copied, transferred or deleted.
- Change Control automatically maintains a secure, time-stamped audit trail of all changes made to any electronic record (who, what and when).
- Accurate and Complete Copies of Records can be displayed in electronic format and can be printed (based on system controls, access and permissions).
FDA GxP (GMP, GLP, GCP)
TMS Quality Compliance Software assists those companies who operate in highly-regulated industries with the challenges of achieving and maintaining on-going compliance with FDA’s GxP regulations.
TMS technology automates and supports your processes to seamlessly manage quality and compliance needs, improve operational efficiency, lower the overall cost of compliance and reduce the risk of non-compliance. Our solution provides:
- Streamlined Workflows (manage processes from implementation to finish)
- Audits Trails & Reports (efficiently prepare for inspection and execute audits)
- Controlled Documents (essential information is readily available and accessible)
- Training Management (certifies your workforce is trained and qualified with defined roles)
- Change Control (maintains a history of changes with audit trails for transparency)
- Electronic Signatures (capture date and time stamp for adherence with 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 provides software automation solutions to effectively manage processes for quality, compliance, and risk so that you can be more proactive than reactive. TMS helps companies streamline operations, increase productivity ensure compliance and reduce costs.
TMS reduces the burden of FSMA Compliance & Audit-Readiness:
- 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)
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 software replaces paper-based systems to automate and integrate your quality management processes and fulfill compliance requirements. Ensuring that processes are being followed helps dodge non-conformance issues to avoid the risk of non-compliance.
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 Graph (a tool that calculates the probability and severity of risk)