Octave Reliance applications

Octave Reliance includes 40 ready-to-use applications for end-to-end quality coverage. They are organized two ways. The core applications, such as document control, training management, audit management, corrective action (CAPA), change management, suppliers, materials and chemicals, risk register, release management and Insights, form the foundation of effective quality management at any scale. Application sets group related applications around a business process, such as new product introduction, supply chain quality, nonconformance handling, enterprise risk management, health and safety, environmental management, life sciences compliance, lab investigation and quality events. You can deploy them individually or integrate them together.

An application set is a group of related management processes that work together to drive operational efficiencies. For example, the supply chain quality set is composed of 4 apps: Supplier Rating, Receiving and Inspection, Production Part Approval Process (PPAP) and Supplier Corrective Action (SCAR). The new product introduction set features 5 apps that help make quality job one on day one. Core applications are the essential building blocks that nearly every quality program needs, and they connect to the application sets. Whatever the issue, a corrective measure can be launched from the appropriate app, guaranteeing process and global reporting uniformity.

Quality Events is an application used to track and trend or manage the investigation process of a variety of unplanned events or deviations that impact the quality, performance, safety or reliability of a product or against cGMP. The app provides a standard process for investigating an event to ensure each investigation is performed consistently and in a timely manner, and organizations can discover trends that might not have otherwise been obvious. It sits alongside the nonconformance handling apps, which manage the review and disposition of production materials that do not conform to specifications. Together they give you a single place to capture every type of event and decide whether it needs to be investigated or just tracked.

The life sciences compliance set consists of 2 apps. Complaints Handling gives life sciences companies comprehensive control over how customer complaints are handled, recorded, reported and tracked in compliance with FDA guidelines, including an electronic form for Electronic Medical Device Reporting (eMDR). The 21 CFR Part 11 and Annex 11 app is a closed system with built-in audit trails and validation support that automates the process of associating an individual’s secure electronic signature with every step in the electronic records keeping process. Both integrate with corrective action (CAPA), Supplier Corrective Action Request (SCAR) and third-party systems such as SAP and Oracle.

The Lab Investigation app helps document the investigation process of an out-of-specification (OOS) or out-of-trend (OOT) lab test result. Users can investigate a result to determine the cause and, through the investigation process, conduct re-sampling or re-testing to confirm the test results. It efficiently tracks, trends and resolves problems identified in laboratory testing. A user can generate a corrective action (CAPA) or nonconforming material report (NCMR) after determining if one is required, and can initiate either directly because the applications are connected through the Reliance platform. In many cases, an OOS investigation can eliminate the need to undertake a more costly and time-consuming CAPA process.

The health and safety set includes 4 apps. Job Safety Analysis breaks a job down into its operational steps and analyzes each step for potential hazards. Behavior Based Safety gathers behavioral data by observing employees and noting any behavior that influences the safety of the work environment. Accidents, Incidents and Safety Reporting provides a central location where all incidents are recorded, with built-in templates for regulatory forms such as OSHA 300, 301 and 300A. Safety Data Sheets provides staff and emergency personnel with the proper procedures for handling a wide range of substances. Environmental management adds 2 more apps: Aspects, Objects and Targets and Permit Control.

The enterprise risk management solution is comprised of 6 apps: Compliance Obligations, Task Management, Meetings Management, ERM Risk Surveys, Emergency Preparedness and Quality Records Disposition. Compliance Obligations helps you identify, access and evaluate laws and regulations and maintain a central repository for your organization. Task Management ensures visibility and timely completion of all tasks and schedules recurring tasks on user-defined time frames. Emergency Preparedness helps you document, approve and test response plans to ensure business continuity. ERM Risk Surveys provide a systematic, objective way to identify, assess and mitigate risk across your organization.

Yes. The applications are connected through the Reliance platform, so information flows between them. Whatever the issue, nonconformance, customer complaint or audit finding, a corrective measure can be launched from the appropriate app. Suppliers, materials and chemicals data is accessible from apps such as life sciences compliance, receiving and inspection, nonconformance management, Supplier Corrective Action Request (SCAR) and change management. REST APIs and prebuilt connectors enable data flow with ERP, MES, PLM, LIMS or HR systems, eliminating duplicate entry and ensuring a single source of truth. You can also synchronize master data via third-party integrations such as Epicor, SAP and Oracle.