A PHASED APPROACH

Choose the right services for your needs.

InfinityQS® recommends a range of deployment strategies to accelerate adoption and help you maximize your InfinityQS system based on your unique situation. From initial assessments that can help you plan out your deployment, to validation services for businesses that need to meet regulatory or other demands—we have you covered.

Discovery and site assessment

Before you begin quality control initiatives with InfinityQS, develop a strategic plan that addresses your manufacturing requirements. Expert site assessments from InfinityQS or our trained service providers can provide a comprehensive roadmap for planning, implementing, and managing a real-time quality intelligence and statistical process control (SPC) system. This plan can help you to determine the time frame and implementation schedule that makes the most sense for your business. Whether you use InfinityQS or a service provider to provide all or some of your implementation services, the roadmap is a valuable tool for a winning quality control solution.

First, our experts work with you to discover your greatest need or area of opportunity. We help you evaluate and verify your environment, identify your priorities, and set target dates.

Implementation Assessment

Based on what we learn during the discovery stage, we help you plan a deployment strategy that enables you to begin using your InfinityQS solution as quickly as possible, while considering any need to build and expand the reach of your deployment moving forward.

Initial launch

For smaller organizations or those that want to deploy a pilot to test an InfinityQS solution in one site, we begin with an accelerated launch program. This approach activates the solution and creates integrated processes and workflows that are proven to improve quality metrics. This phase offers the quickest means for achieving important milestones:
  • Begin entering quality data on the shop floor
  • Import appropriate specification limits into the InfinityQS system
  • Provide real-time visibility for management into process or product quality issues
  • Create management roll-ups, reports, and summaries of quality data
  • Monitor and display alarms that indicate out-of-control or out-of-specification conditions
  • Activate email alerts

Implementation Assessment

Expanded deployment

For businesses that need or choose to move beyond the initial phase, we offer assistance developing an expanded deployment. This phase focuses on incorporating automated data collection methods, from manual operator input to electronic data collection. During this phase, you reach important milestones for more complex environments:
  • Automate data collection from electronic devices such as scales and hand-held gauges
  • Expand the use of quality intelligence and SPC throughout the plant or across other sites
  • Enhance the depth and breadth of management reporting
  • Create reports for communicating with management, customers, and suppliers
For larger companies, enterprise-wide deployments offer the ability to complete your implementation across all facilities and even into your supply chains. With an expanded deployment, your entire database structure is organized and populated, correct statistical tools are selected, projects are developed, workstations and gauges are set up, and all appropriate training is conducted. InfinityQS or service provider experts can help to expand your deployment to achieve these milestones:
  • Collect process data, such as machine speeds, feeds, and temperatures
  • Develop a complete picture of product and process quality for analysts
  • Automatically integrate data from other systems, such as manufacturing execution system (MES) or enterprise resource planning (ERP)
  • Capture and share metrics and activities from across the production process
  • Update reporting to include additional data sources
Implementation Assessment

Data integration

InfinityQS solutions are designed to work with your existing business system software. Many of our customers need InfinityQS to "talk" with existing systems such as laboratory information management system (LIMS), ERP, and MES implementations. Fortunately, our open architecture makes this type of communication possible.

To accelerate data integration, InfinityQS offers integration tools, software components, data collection hardware components, and technical support services, including Professional Services provided by InfinityQS or service providers. Discover more information about expanding your deployment.
 
Implementation Assessment

Gap analysis

Are you getting the most out of your InfinityQS solution? InfinityQS's on-site gap analysis can help you determine how to enhance and improve your deployment. Seasoned applications engineers evaluate your existing implementation and deliver expert suggestions for how to optimize your use of InfinityQS. Our teams help to provide answers to your most pressing questions:
  • How can you simplify the system for shop floor operators?
  • How can data collection be more efficient?
  • How can data from critical systems be consolidated into InfinityQS?
  • How can reports be improved to provide powerful, actionable information for managers?
  • How can system maintenance costs be reduced?
Whether you want to optimize results or establish a roadmap for improving the performance of your quality system, InfinityQS and its service providers offer expert assessment services to help you maximize your deployment.
Implementation Assessment

Validation (ProFicient™ customers only)

For ProFicient customers, InfinityQS offers two levels of validation assistance, depending on the needs of your organization and industry.

Advanced validation

Our Advanced Validation package provides essential elements for system qualification, including installation verification (IV) and operational qualification (OQ) documentation and a validation protocol. Although your organization likely has a unique functional requirements specification (FRS) based on your specific operating policy, quality directives, validation needs, and regulatory requirements, a basic FRS document is provided with the IV/OQ protocol. The package also includes a preformatted database.

Test cases are a primary part of the Advanced Validation package. The IV documentation consists of test cases to verify that components of the InfinityQS SPC Manufacturing Intelligence (ProFicient SPCMI) have been installed properly according to InfinityQS recommendations and documentation. The OQ documentation consists of test cases to verify that key components of the ProFicient SPCMI are operating properly according to InfinityQS specification and are in compliance with provisions of FDA 21 CFR Part 11. The OQ can also be used to validate ProFicient sampling requirements through use of the Dynamic Scheduler.

IV and OQ verification test cases include the following:
  • System Documentation
  • Standard Operating Procedures
  • InfinityQS Database Manager Installation
  • InfinityQS SPC Manufacturing Intelligence Installation
  • InfinityQS Dynamic Scheduler Installation
  • Operational Qualification (OQ)
IV and OQ setup and operational qualification test cases include the following:
  • Reason for Change and Security Policy
  • Organization and Roles
  • Employees
  • Part Groups and Parts
  • Process Groups and Processes
  • Defect/Defective Groups and Codes
  • Test/Feature Groups and Tests
  • Descriptor Category and Descriptors
  • Lots
  • Assignable Cause Group and Corrective Action Groups
  • Corrective Action Codes
  • Assignable Cause Codes
  • Alarms
  • Specification Limits
  • Sampling Requirements
  • Project and Data Configuration Setup
  • Subgroup Data Entry, Control Limits, Alarms, Warning Messages, Equation Calculation
  • 21 CFR Part 11 Regulatory Compliance (System Access, Password Aging, Electronic Records)
If you need to perform a formal software validation but lack the resources to meet an aggressive implementation schedule, InfinityQS can provide additional services to assist with the execution of the IV/OQ protocol.
 

Expert validation

In our Expert Validation package, the Performance Qualification (PQ) verifies the operation of the InfinityQS ProFicient SPCMI, to confirm that the system performs as intended and satisfies defined and approved user requirements and user-provided test case prerequisite data. The PQ is the responsibility of each InfinityQS user in your organization. InfinityQS offers additional services to help develop user requirements and to prepare and execute customized PQ protocols.

The Validation Summary Report (VSR) summarizes the results of the execution of the test cases that are outlined in the package’s IV, OQ, and PQ. The VSR documents the acceptance or rejection of the system for production use. Like the PQ, the VSR is the responsibility of your users.

The Expert Validation package IV/OQ is a self-contained protocol that provides the following:
  • Review and Approval Signoff
  • Revision History
  • Introduction
  • System Description
  • Scope
  • Glossary of Terms and Acronyms
  • Test Strategy (Scope, Approach, Acceptance Criteria)
  • Roles and Responsibilities
  • Test Organization
  • Deviations Handling
  • Execution Procedure and Test Review
  • Test Cases
  • Deviation Report Form
  • Deviation Report Log
  • Signature Log
  • Data Sets
  • Expected Results
All test cases in the Expert Validation package include the following:
  • Test Requirement
  • Acceptance Criteria
  • Step Numbers
  • Instructions
  • Expected Results
  • Pass/Fail Categorization
  • Executor Signoff and Dating
  • Reviewer Signoff and Dating
  • Comment

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