windchill product quality saas overview 1. introduction · 2018-12-18 · windchill product quality...
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Windchill Product Quality SaaS Overview
PTC October 1, 2018 Page 1 of 11
1. Introduction
The scope of this document is to describe the PTC medical device branded solution Windchill
Product Quality (WPQ) Software-as-a-Service (SaaS) and the processes for delivery of the WPQ
SaaS offering. The offering is available only as SaaS through the PTC Cloud Services and
enabled by the PTC Partner program.
The document will focus on:
• WPQ SaaS solution overview, licensing, and add-ons
• Describe how Partners will work with the Customer, PTC Cloud, and third-party validation
services to deliver the WPQ validated solution
• Extending Windchill with ThingWorx Navigate
• Frequently Asked Questions (FAQ)
1.1 WPQ SaaS Solution Overview
Windchill Product Quality is a purpose-built offering for life science, medical device and
biomedical customers. It extends PTC’s Windchill PLM platform by offering a ‘validation ready’
PLM SaaS solution incorporating functionality and best-practices for meeting regulatory
requirements from organizations such as the US Food and Drug Administration (FDA) and the EU
Commission’s Medical Device Regulations (EU MDR). The branded PLM SaaS solution focuses on
establishing a holistic PLM and QMS solution for product quality centered around a best practice
design control process.
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The PLM & Quality solution comes pre-configured with best practices centered around a parts
centric approach to design control and product quality. The best practices were built upon ISO-
9001 and harmonized with ISO13485 2016. These pre-configured solutions were designed as a
baseline configuration for the customers final to-be workflows. They can be updated and
enhanced through configuration and can support certain levels of integration. A guidance
document can be provided so that configuration and customizations are forwards compatible
with future release of Windchill supported by PTC Cloud services.
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1.2 WPQ Capabilities License Overview
The base solution includes the Windchill components listed below.
• Windchill Design Control
• eBOM Management
• Change Management
• Design Review
• Design History File (DHF)
• Device Master Record (DMR)
• MCAD Data Management – Creo (included), Solidworks, Inventor, AutoCAD
(additional)
• Windchill Document Control and Document Training
• Windchill Quality Management
• Customer Experience Management (CEM)/Complaints
• Corrective Action/Preventive Action
• Nonconformance
• Windchill Base Reporting
• Windchill Creo (multi-CAD) View Adapters
1.3 WPQ Capabilities by Roles
WPQ Core Capabilities View Contribute Author Find and view product information
Search indexed and non-indexed content
Define and execute user-specific saved searches (but not global searches) ✓ ✓ ✓
View any web page and web page content to which the viewer user is granted
authorization ✓ ✓ ✓
Download and view any office document content
Download any pre-published derived formats (PDF, IGES, STL)
Request publishing of derived formats on demand (for those supported)
Do not download any native CAD formats (MCAD, ECAD…)
✓ ✓ ✓
View reports created by others but cannot create or edit reports ✓ ✓ ✓
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View thumbnails and 2-D and 3-D images
Pan, zoom, rotate, measure, section, explode
View but do not create/edit annotations
✓ ✓ ✓
Subscribe to be notified of events on items to which user has access ✓ ✓ ✓
Contribute, participate & collaborate
Create/edit folders
Create/edit links ✓ ✓
Workflow tasks
Project tasks
Action item tasks
✓ ✓
Create topics and discussion postings
Create and save annotations
Create/update action items
Create/attach/edit office documents (including use of Desktop Integration)
Create and update meetings
Participate in projects (does not include capability to create or manage projects,
plans, schedules, resources)
✓ ✓
Create/update problem reports ✓ ✓
Create deviation or waiver ✓ ✓
Create/attach/edit office documents (including use of Desktop Integration) ✓ ✓
Ability to have Document Control specific workflows: SOPs, Records Management,
SOP Training Related, Coversheet with watermarks ✓ ✓
Create/update Corrective and Preventative Actions process ✓ ✓
Create/update Complaints process ✓ ✓
Create/update Non-conformances process ✓ ✓
Electronic Signatures & CFR Part 11 Compliant Audit Trail ✓ ✓
Basic Authoring of content, and release and change management
Create and Manage Design History Files and Device Master Records ✓
Create Formal Design Reviews with audit trail and e-signatures ✓
Create and manage change objects of all types ✓
Create and manage collaboration project and plans ✓
Create and manage baselines ✓
Manage release process, set life cycle states, initiate workflow processes (such as
promotion requests) ✓
Manage templates and attributes (documents, parts, projects, teams, lifecycles,
workflows) ✓
Create and Manage global searches and reports ✓
Create and Manage Training Records ✓
Create and Manage Qualified Roles ✓
Create and manage projects, project teams and project content ✓
Create and manage project templates, team templates and project workflow
templates ✓
Create, execute and manage project plans with milestones, activities and tasks ✓
Create and manage project resources (people, equipment, facilities…) ✓
Create and manage action items, discussion forums and notebooks ✓
Create and manage project reports ✓
MCAD Data Management
Create and manage MCAD models using workgroup managers for all PTC-
supported CAD applications including Creo Parametric, Creo Direct, Creo
Elements/Direct, Creo Schematics, Creo Illustrator and Mathcad
✓
Create and manage MCAD models using workgroup managers for Solidworks,
Inventor and AutoCAD ✓
Automatically publish CAD formats with included Creo View CAD adapters for
Inventor and SolidWorks (native publishing is supported for Creo and AutoCAD) ✓
BOM Management
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Automatically create and associate part BOM items with CAD documents on CAD
document check in ✓
Create and manage product structures and engineering BOMs ✓
Import BOM structure from Excel ✓
Create and manage product structure baselines ✓
Create and manage product instances ✓
Create and manage serialized products ✓
Transform a CAD BOM into a part BOM ✓
Intellectual Property Protection
Create and manage security labels and classifications and control access to
information based on user or group label or classification access level. ✓
Create and manage agreements (such as NDA, ITAR) and control access to
information based on the agreements that a user or group is covered to provide
access to agreement-controlled information.
✓
Manage agreement creation and change through workflow process ✓
Control which representations of content are available for view and download by
groups/roles and users. For example, some users may be given access to native
CAD formats and others will have only access to low-fidelity 2-D images or 3-D
viewable.
✓
An IP Protection add-on license is required for every user with access to a Windchill
system in order for a customer to use any IP protection functionality. User's with an
Author license can create and manage IP protection labels, agreements and
rules. All other users can view IP information for content to which they have view
access but cannot perform any of the IP Production management functions
above.
✓
1.4 WPQ Add-On Capabilities by Roles
WPQ Add-On Capabilities – Additional Charges View Contribute Author Manufacturing Process Management
Transform an engineering BOM to a Manufacturing BOM ✓
Create and manage manufacturing resources ✓
Create and manage process plans that use manufacturing resources ✓
Create and manage manufacturing BOMs ✓
Navigate
Use the capabilities of the Navigate Role based applications and ADK to view
Windchill data and custom applications for viewing information from PTC and non-
PTC systems.
Note: This license does not include support for building applications that create or
edit information in systems or connect to physical devices.
✓
Use the capabilities of the Navigate Role based applications and ADK to create
and edit Windchill data and custom applications from PTC and non-PTC systems.
Note: This license does not include support for building applications that create or
edit information in systems or connect to physical devices.
✓ ✓
Cloud Add-Ons – Additional Charges
Additional Environments
Additional Validation Services
Customizations & Integrations
Additional Storage
Single Sign-On
1.5 Partner Delivery
Partner solution configuration, development, and delivery is an important component of
customer success for the WPQ offering. When selecting a Partner for a WPQ solution, it is a
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prerequisite that the Partner has expertise and experience delivering both Windchill and Quality
solutions. See the PTC web site for additional materials on the Partnership Network.
For additional information on Partner led PTC Cloud deployments see the PTC Cloud Service
Description Document.
1.6 Validation Ready Solution
For WPQ PLM SaaS, PTC partnered with USDM Life Sciences to provide customers with validation-
ready documentation (called the Validation Accelerator Pack (VAP)) for the pre-configured
best practice solution. After purchasing the solution, customers are provided with the
documents listed below by USDM. These documents provide the core for the base validation.
• System Requirements Specification Report- Admin & General
• Windchill Administrative and General Risk Assessment
• Windchill Med Cloud IOQ Summary Report
• Windchill Med Cloud Validation Plan
• Windchill Med Cloud Validation Summary Report
• Windchill Document Control VAP UAT
• Windchill Med Cloud Operational Qualification
• PTC Corporation Quality Audit Report
• Document Control
o System Requirements Specification Report-Document Control
o Windchill Document Control Traceability Matrix
o Windchill Document Control Risk Assessment Matrix
• Design Control
o System Requirements Specification Report-Design Control
o Windchill Design Control Traceability Matrix
o Windchill Design Control Risk Assessment Matrix
• Quality Management
o System Requirements Specification Report-NC, CAPA, Complaints
o Windchill NC, CAPA, Complaints Traceability Matrix
o Windchill NC, CAPA, Complaints Risk Assessment Matrix
Once solution development is completed, the USDM VAP documents can be utilized to jump-
start the changes to the requirements, traceability, IQ, and OQ documentation; along with,
supporting the customer’s Performance Qualification (PQ) and User Acceptance testing (UAT).
For all WPQ SaaS deliveries, the engagement of USDM will be initiated through our PTC Cloud
Service Management processes (see below).
PTC’s responsibility for the Validation of the customer’s system consists of standard evidence in
support of IQ and OQ that is provided to USDM as input to their VAP. Modifications to the
standard solution will require (as a pre-requisite) a written IQ and OQ plan with updated
evidentiary requirements.
2. Partner Delivery Process
2.1 Initial Delivery of the WPQ SaaS Instances
The initial delivery process starts after the customer completes the sale. During this process, PTC
Cloud is preparing the customer’s WPQ instances (development and production) and USDM is
completing their documentation.
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The customer delivery timeframe will be confirmed by the PTC Cloud Service Management as
part of the sales closure process.
At the end of this process:
• The customer has access to the WPQ Cloud service.
• The validation document package has been delivered for the base solution.
• The customer/partner are ready to complete the development and configuration of the
solution.
Figure 1: Process steps from PO to URL delivered
2.2 Solution Development and Configuration
After the instances are installed and Service is available to the customer, the customer/partner is
ready to complete the solution configuration and development. During this phase, it is
important to keep track of the base solution changes to help identify which portions of the
solution requires additional validation. The PTC Cloud team will support build package and data
migrations for this phase. The changes and corresponding validation evidence is the customer’s
responsibility.
It is the customer’s/partner’s responsibility to keep track of changes (using a change
management process) and determine the level of re-validation required. The customer can
choose to complete the solution validation or have USDM participate in the process.
PTC Cloud Services will require Customer or USDM generated instructions for any deviations from
the standard evidence required to support IQ or OQ prior to executing any changes to the
delivered system. This includes changes to installed software components and the Windchill
PDMLink configuration.
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There may be additional fees when making such modifications. This should be discussed
proactively with Cloud Service Management.
Figure 2: Process for configuring baseline solution
2.3 User Acceptance Testing
Once the solution and initial validation is completed (or an out-of-the-box solution is being used)
the solution is ready for User Acceptance Test (UAT). The UAT is completed by the customer
and/or partner.
After the UAT is completed, the customer notifies the PTC Cloud Service Manager to deploy the
solution into the Production environment.
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Figure 3: UAT process flow
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Sample Validation Project Plan
3. Post Production Changes
Once the customer is in Production, a Change Management process must be followed. There
are three types of changes that can be applied to the WPQ Service: System, Application and
Solution.
It is a joint PTC and customer responsibility to keep track of changes and ensure that an
appropriate change management process is followed. PTC will inform the customer of all PTC
initiated changes.
Note: There are some changes that typically do not require change management as long as it
does not modify the intended use of the application. An example of this type of change is data
input.
3.1 System Change
A System change is when the application operating environment is modified. Examples of
system changes include an upgrade to the operating system, Java version, or database version.
For each System change, PTC will work with USDM and evaluate the change to determine if it
modifies the intended use and requires additional validation. PTC will provide notification before
the change is made. Customers can utilize the notification to execute their own Change
Control process and determine if additional validation is required.
3.2 Application Changes
An Application change consists of the installation of a patch, minor release, or major upgrade
applied to the current version of the PTC Windchill application.
For a major functional release, a complete revalidation is typically required. A minor release
(containing issues resolution); the addition of new functionality; or changing existing functionality
usually requires some revalidation.
PTC and USDM will determine which specific versions of Windchill will be deemed Validation-
ready and will coordinate with the customer on when to execute an upgrade to their specific
environment(s).
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For each Application change, PTC will work with USDM and evaluate the change to determine
the level of revalidation. Once implemented and tested, PTC and USDM will provide updated
validation documentation for the new standard solution.
Customers can utilize the updated documentation to execute their own Change Control
process and determine if additional validation is required. Customers will be required to provide
PTC with documentation that outlines their specific validation requirements to deploy their
solution to the upgraded version. There may be additional fees assessed to support the
additional validation beyond the standard offering. This should be discussed proactively with
Cloud Service Management.
3.3 Solution Changes
A Solution change is when a configuration or customization is modified and applied to the
current application version. Examples include new reports and queries, new workflows or
changes to existing workflows.
The addition of new fields or changing existing ones; if only through the core application,
typically require an update to the Configuration specification and change verification;
however, the usually do not require revalidation.
For each Solution change, Partners and Customers should execute their own Change Control
process and determine if additional validation is required. PTC will require that customers submit
a written explanation of Validation requirements when requesting PTC to propagate approved
solution changes to their production environment.
4. Extending WPQ PLM SaaS through PTC ThingWorx Navigate
WPQ PLM SaaS can be extended with ThingWorx Navigate to enhance and drive new positive
customer experiences. This can be purchased as an add-on to the existing solution and requires
a separate dedicated cloud environment. The USDM VAP does not currently include readiness
for Navigate and additional validation will be required.