Our PTC Integrity Services

SPK and Associates is a long-time PTC Service Advantage Partner with extensive experience with the PTC Integrity Lifecycle Manager.   We offer a complete service portfolio for you choose from:

Architecture Design/Assessment

Are you a new customer considering PTC Integrity for your organization and need a partner to help you design the implementation? We bring multiple industry knowledge and Integrity Best Practices to align and optimize your design.
Are you an existing PTC Integrity customer and need some help to update your environment? Lets us work with you to create a design which aligns with your new business needs.

Implementation/Customization

Do you need implementation or customization of PTC Integrity?  We have years of implementation and customization experience.   SPK engineers will handle the complete project (end-to-end) for you

Training

SPK and Associates has delivered User and Administration Integrity Training for many customers.  We offer training options:

  • Factory PTC (Out-Of-The-Box) Integrity (Base Integrity, Requirements & Workflow Management, Test Management,  Software Configuration Management).
  • Customized Training (Incorporate your company use models and nomenclature)

Data Migration

Let us help you move your legacy data into PTC Integrity Lifecycle Manager

Verification/Validation (CSV)

SPK and Associates is PTC’s go-to company for Integrity CSV’s. We’ve developed an accelerated validation package with services based on:

  • Having Done Many CSV’s for Many Software Tools and Working with FDA Auditors
  • Our Experience With Integrity – Knowing how to leverage out-of-the-box functionality and update to your Intended Use
  • Industry Knowledge

The Computer System Validation (CSV) Deliverables Include:

  • Part-11 Assessment Summary – Specific items associated with 21 CFR PART 11.
  • Integrity Risk Assessment – High level FMEA Risk Assessment Items with associated Risk Control Items: COTS Focus.
  • System/Business User Requirements – High-level Requirements covering IQ/OQ and PQ items.
  • Functional Requirements – Breakdown of User Requirements into Functional Requirements.
  • Test Scripts – Protocol Un-Executed Scripts.
  • Validation Summary Report –  Validation Summary Report including Test Results from Test Scripts, Test Metrics, Deviations, and Objective Evidence (screenshots).
  • Deviation Log – Further Detail of Deviations for follow-up/closure.
  • Traceability Matrix – Mapping of User Requirements, to Functional Requirements, to Test Cases and Test Case Verdicts.

Hosting of your PTC Integrity Environment

If you don’t want to deal with the cost of hosting the PTC Integrity Instance(s) in your company infrastructure, let us do it for you!   We provide this service for several customers delivering a hassle-free, secure, and private cloud solution for a monthly fee.

Download our SPK Integrity Private Cloud Hosting datasheet

Application Management Support

If you don’t want to hire (or allocate resources) for an Integrity Administrator, let us take care of your Integrity Application Management.   For several customers we are considered part of their support team, from help desk to ongoing services for a monthly fee

Each Support Contract is customized for you (as little or as much support as you need)

Integrity Application Management

Application Management Example Services

Business Process and Architecture/Design

Architecture and Process Consultation for Industry Best Practices.

Configuration and Subsystems Support

Ongoing configuration changes to execute on Sprints
Ongoing report customization
Ongoing minor workflow, event triggers and security changes
Categories/fields/compute fields updates

Application Platform and Infrastructure Support

PTC RFC Tracking
Automated monitoring, alerting and remediation of application and infrastructure issues
Application patching
Performance management
License server management
License Utilization Monitoring and Monthly Reporting
Minor application upgrades (major upgrades usually require a project)
Application and OS Log Review and Management
Support of existing integrations between PTC and other third party Engineering tools
Vendor Management

Application Help Desk/User Support

Ongoing User support
User add/delete/change requests
Role administration
Problem resolution
Ongoing training video development
Management of User wiki knowledge base

Download our SPK Integrity Application Management datasheet

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