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QMS & PLM Education

Integware brings leading experts on Product Lifecycle Management and Quality Management Systems to deliver premium QMS and PLM education and asessment.

We offer a variety of PLM and QMS training classes, including:

QMS Training

In our QMS training course Integware discusses:

  • The core concepts of QMS system, basics and good constructs
  • Components of a good QMS system (covering people, processes and tools)
  • Introduction to 21-CFR-Part 820 (FDA Quality System requirements) and ISO 13485
  • Understanding each aspect of part 820 and equivalent 13485 sections (including management responsibilities, design controls, production controls, CAPA, etc.)

The course includes a written test and certification as well as a student lead exercise at the end developing a recommended people-process-tools approach to solving a variety of QMS issues.

(NOTE: This course is Ideal for all involved in QMS, especially QMS managers and quality function personnel)

Audit Readiness
Recommended Pre-requisite: QMS Training
In our Audit Readiness training, we provide an in-depth course covering the following topics:

  • Introduction to FDA
  • Types of inspections
  • Quality System Process overview
  • Demeanor/etiquette and approach with auditors
  • Preparedness
  • Managing the team and the “response preparation room:w
    “
  • Working with the auditor
  • And responding to findings

(NOTE: Ideal for team members involved in agency inspections)

PLM Maturity Model® Training

In our PLM training course we cover the different aspects of Integware’s highly popular PLM Maturity Model® and introduce core technology concepts. The course approaches the four levels of the PLM Maturity model:

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Level 1 - PLM Framework: This covers the foundational components of PLM and discusses the various PLM systems on the market. This looks at what comprises a PLM system, basic concepts such as vaulting, objects, relationships, search, security, etc.

Level 2 - Foundation: This part of the course covers change control, document management and new product introduction process. We review approaches to change control and best practices business rules in this space.

Level 3 - Engineering: This part of the course reviews the liberating of information from documents into information driven approach. During this course, we review advanced capabilities such as Bill of Material (BOM) Management, Device Master Record, CAD and ERP integration techniques. We also review advanced business rules for these layers such as those critical to BOM management and product configurations.

Level 4 - Advanced Integrated Automation: This training course looks at other advanced areas of PLM which drive the workflow and integrated data-driven (as opposed to document driven) flows across the entire lifecycle. The course is broken into five distinct categories:

Management Responsibility

  • Production and Process Controls
  • Design Controls
  • CAPA
  • Early research stages of the product lifecycle

The course includes a written test and certification as well as a student lead exercise at the end to solve a particular business problem using PLM components.

Throughout this course we review how the business can be positively impacted by PLM technologies in a variety of situations.

 

(NOTE: Ideal for team members interested in implementing PLM systems, the course covers some technical topics but is generally light in nature and as such technical expertise is not required)

Integware brings experts in QMS, medical device product development, former FDA auditors and product lifecycle experts to help assess your quality management and product lifecycle processes.

QMS Maturity Assessment

Integware will review your Quality Management System to identify the level of the organization’s maturity in relation to industry benchmarks. In this activity we use our Quality Process Maturity Assessment (QPMA) benchmarking tool. Characteristics that are measured include:

  • Adherence to the process
  • Process acceptance
  • Adoption of industry best practices
  • Automation level
  • Consistency

Through this process we examine the different aspects of the Quality Management System and we assess the level of process maturity, identify gaps and make recommendations for areas that require process optimization. We start this process by performing an onsite assessment that can vary in duration depending on the size of your company and magnitude of assessment. This can be comprehensive or focus on a specific area of the QMS and product lifecycle (depending on your needs which we assess during an initial consultation). Our team of experts will be thorough, identify risks, gaps, and look for areas where optimization activities may be warranted.

Mock GMP Audits & Audit Readiness

In preparation for an agency audit, our auditing specialists (include former regulatory auditors) conduct an onsite audit of your quality system, in a similar manner as a formal FDA audit. This includes reviewing the quality manual and all associated Standard Operating Procedures (SOPs), work instructions, records, etc. Following the audit, Integware will provide a detailed report identifying gaps and findings, clear explanations of the gaps and findings, and an Audit Readiness Roadmap for the implementation of suggested fixes. In addition to the Audit Readiness Roadmap, Integware will also provide staff coaching on regulatory inspection practices, types of questions to anticipate, and how best to prepare fpr FDA audits.

Agency Inspection Support

During the period of an audit Integware can provide experts to help support the activity and communicate with FDA on regulatory/compliance matters.*

* Subject to availability