QMS使用者基礎訓練課程
作者：賴立仁
Email :
Lijen.lai@gmail.com
版本：Version 1.0
公司：富博科技
課程大綱


1.Windchill 簡介
1.1 Windchill Overview




2.登入 Windchill
2.1 透過 browser 登入 Windchill(各廠browser版本限制)
2.2 透過 e-mail 登入 Windchill















3.Windchill的工作清單(工作分派)
3.1說明工作分派
3.2善用工作分派
3.3完成工作分派
4.物件庫簡介
4.1 QMS 管控與物件庫
4.2 物件庫內容介紹與使用
4.2.0
物件庫 overview
4.2.1
使用附件
4.2.2
使用PDF(客製化產出)
5.搜尋流程文件
5.1
建立,管理,分享搜尋
5.2
自訂產出檢視
5.3
產生各類產出格式
Windchill Overview
Pharma – What’s it all About?
Pharmaceutical Manufacturing – Drugs and Solutions are highly regulated by the FDA and various other agencies. It is
essential to manage a Master Production Record (MPR) and Batch Production Record (BPR) for every drug or solution produced.
RISK
WC PDMLink
Change
Management
Store BOM’s
which include
Documents
and Parts
Design and
Process
Control
Benefits
WC
ProjectLink
NPI and
Automation of
that Process
Pharma MFG
MPMLink
Asset
MPR
BPR
Master Checklists
Risk
Preventive
Maintenance
and
Calibration
Arbortext
Unites product development
activities addressing quality
Connects the quality efforts of crossfunctional teams
QMS
Deviations,
Complaints,
CAPA’s,
Audits, and
Training
Provides a single source of truth to
improve management visibility
Structured
Product
Labeling and
Submissions
REPORTING
Life Sciences
4
Pharma MFG Process Flow Diagram
Mfg Batch Production Record (BPR)
Program Start
Quality
Template BPR Checklist 201
Drug A
Quality
Planning
Drug A - Lot
1
MPR Version 201
Governance
Drug A - Lot2
Complete BPR Checklist for Each Lot
Batch History Record Forms & Reports
Drug Master File
Design
Validation
Change
Management
SOP
Management
Closed-loop
Integration
Quality
Management
Reporting /
Dashboards
Incorporate Identified
Changes
Quality
Governance
Master
Production
Record (MPR)
Master
Production
Checklist
MFG
Critical Process
Control (CPP)
Lab Information
Management (LIMS)
Specification Tests
CTQ Validation, Tracking
Store, Communicate
Feedback to Other
Lifecycle Stages
Configuration
Management with
BPR and MPR
Material List
Operation
Steps
Control Plans
Manufacture
Quality
Integrate Engineering,
Production,
Execution
Yield Verification
Chemistry, QA & RA
Samples, Execution
Validate Solution
Conformance
Temporary Process Change (TPC)
Deviation
Final
Retention
Samples
Maintenance Policies
and Spares Planning
Asset
Preventative
Maintenance
Calibration
Failure Reporting /
Complaints
Process Analysis & Feedback (SPC)
Permanent Process Change (PPC)
Failure Analysis
Root Cause Analysis
Life Sciences
Corrective and
Preventive Action
(CAPA)
5
Windchill Overview
Windchill
PPM/PM
Windchill
RequirementsLink
Mathcad
Pro/ENGINEER
ProductView
Cadence, Mentor,
Zuken
Program Portfolio/
Project Management
Requirements
Management
Engineering
Calculations
MCAD /
CAM / CAE
Digital
Mockup
ECAD
Document
Management
Workflow
Heterogeneous
CAD Data Mgmt
ECAD Data
Management
Complete BOM
Management
Enterprise
Interoperability
Distributed
Collaboration
Communities
of Practice
Visualization
Change &
Config. Mgmt
ERP
Financials
SCM
MRP
SAP, Oracle,
Dynamics
Life Sciences
Product
Lifecycle
Management
Service
Information
Manufacturing
Process Mgmt.
Quality, Risk
& Reliability Mgmt.
Product
Analytics
Supplier &
Component Mgmt.
Embedded
Software
Arbortext
Windchill
MPMLink
Windchill
Quality
InSight
Windchill
PartsLink
Open Source,
Rational
6
Windchill 系統操作
© 2006 PTC
登入 Windchill
IE Internet Explorer 8.0 is recommended over Internet Explorer 7.0,
as there have been performance improvements in Internet Explorer 8.0.
URL:
Production 環境 :http://sptplm.scinopharm.com.tw
Development 環境:http://sptplmdev.scinopharm.com.tw
使用者名稱: AD 帳號(不包含domain name exp :Tommy.yang
Windchill的工作清單(工作分派)
物件庫簡介
QMS 管控與物件庫
依照各個流程的特性,分別建立個別物件庫存放,每個物件庫有該流程的使用
限制,如使用者群組,流程邏輯,產出 pdf 格式….exp:DMR 指專門存放 DMR 管理流程
輸出 pdf與使用附件
搜尋流程文件
Q&A
Project Management (NDA, Quality Improvement
Projects and Compliance Audits)
A Proven Solution for Collaborative Project Management throughout
the Product Lifecycle
> Project-related information management
– Global access to all project-related product data
including designs, models, etc.
– Web-based project portal with embedded 3D
visualization, search
> Project collaboration and management
processes
– Self-administration project management
– Distributed cross-enterprise team collaboration
> Cross-enterprise access to project
information
– Anywhere access to project data through
intuitive browser-based user interface
– Integration with data authoring applications
> Bi-directional Microsoft Project integration
Life Sciences
© 2006 PTC
19
Audit Execution – Project Roll Up Status Tracking
Life Sciences
© 2010 PTC 20
Document Structure Management
Create and manage documents and document
structures with full version, lifecycle and workflow
control.
Capabilities
Hierarchical Document Structures
Associate with parts, products or other documents.
Benefits
Comply with FDA, ISO and internal standards.
Speed creation, approval, training/effectivity, usage.
Document Structures
Life Sciences
21
Document Signature
Capabilities.
21 CFR Part 11 compliant electronic signatures.
Benefits
Reduce compliance risk.
Reduce errors and unnecessary delays.
Complete, automated tracking and traceability.
Windchill electronic signature records:
• Identification of the user who completed the task, link to a
signature file.
• Identification of the role the user assumed for performing the
task.
• Disposition of the user’s vote.
• Identification of instructions for the task.
• Capture of comments and other information associated with the
task.
• Identification of the time that the task was completed.
• Signature information for the signed object and associating it with
the signed object in the database.
Life Sciences
© 2010 PTC 22
Lifecycle Management
Capabilities.
Define and manage document Life Cycle phases.
Associate workflow and control access by Life Cycle.
Define and enforce training & approval matrices.
Benefits
State
Earlier Input from CCB & ECCB
Reduce compliance risk.
In Work
Released
Effective
Canceled
Reduce errors and unnecessary delays.
Gate
Complete, automated tracking and traceability.
Phase
• Life Cycles are defined by Phases and Gates.
• Life Cycles define an item’s states and define the roles and access
controls at each state.
• Each type of item (Part, Specification, Drawing) may have unique set of
Life Cycle states.
• Life Cycles are iterated.
• Workflows associated with an item Life Cycle manages the maturing
processes from state to state.
Life Sciences
© 2010 PTC 23
Change Management
Capabilities
Closed-loop, automated DCN process by type.
Configure process with graphical workflow editor.
Define and manage document Life Cycle phases.
Associate workflow and control access by Life Cycle.
Define and enforce training & approval matrices.
21 CFR Part 11 compliant electronic signatures.
Integrated Training.
Integrated reporting and dashboards.
Benefits
Reduce compliance risk.
Reduce errors and unnecessary delays.
Complete, automated tracking and traceability.
Life Sciences
Potential Streamlined DCN Form
Section 1: Change Type (Classification)
Class 0 – Typos, grammar, formatting, etc
Class 1 – Quality Documents
Class 2 – Labeling
Class 3 – DHF?
Section 2: Document Change Information (Doc Number and Description)
Section 3: Description of the Document Change
Section 4: Justification of the Change
Section 5: Training Required
Section 6: Documents Approvals
Section 7: Documents Effectivity
Section 8: Verification of Document Control before Filing
© 2010 PTC 24
Change Management (Continued)
Capabilities
Integrated reporting and dashboards.
Benefits
Detailed Reporting Capabilities
Reduce compliance risk.
Reduce errors and unnecessary delays.
Complete, automated tracking and traceability.
Dashboards & Reports
Life Sciences
© 2010 PTC 25
Reliability Management
>Design and Process FMEA’s, which can have associated Design
Verification Plans (requirement fulfillment and LIMS) and Quality Control
Plans
Perform reliability analyses using
globally accepted standards
Analyze reliability, availability,
and cost using system modeling
Predict repair times to meet
system availability objectives
Analyze potential failures
and minimize their effects
Analyze complex systems with
state transition diagrams
Manage corrective action
processes to improve reliability
Analyze the lifetime cost
of a product
Assess risk and reliability using
visualization and analysis
Life Sciences
Analyze life data throughout
all phases of product life
Assess and mitigate the risk
of human errors
26
Windchill CAPA: M010
CAPA - Corrective Action Preventive Action
Why is it Important?
• Correct and prevent product errors
• Communicate actions to future product design
• Continuous product and process improvement
Common Barriers
• Decentralized systems of quality management
• Manual processes don’t “close the loop”
• IT barriers to configuration and implementation
PTC Benefits
• Highly structured for repeatability of processes
• Trend metrics to track quality compliance
• Easy-to-configure industry-proven templates
Life Sciences
© 2011 PTC
27
Windchill Nonconformance – M020
Why is it Important?
• Quickly Record product nonconformances
• Perform & record immediate actions
• Communicate lessons learned to design
Common Barriers
• Labor-intensive manual intake and reporting
• Tracking an issue through to its correction
• Losing sight of overdue issues, quality trends
PTC Benefits
• Rapid, structured intake & issue processing
• Immediate Corrections against BOM items
• Full MRB & Disposition with sub workflows
Life Sciences
© 2011 PTC
28
Windchill Adhoc Reporting: M010
Why is it Important?
• Users can search data with no IT help
• Quickly review emerging trends
• Trend improvements for quality & compliance
Common Barriers
• Labor-intensive manual reporting processes
• Requires high degree of technical competence
• Losing sight of overdue issues, quality trends
PTC Benefits
• No knowledge of object structures required
• Simple Interface for simple data questions
• Alerts and reports provide system insight
Life Sciences
© 2011 PTC
29
BPR and MPR Publication Development
XML authoring: uses templates for standardized documents
Publishing capability for composition and transformation
Stylesheets for PDF
and Web based
output
Conversion to and
from MS Word
Assembly of
documents for
collection
Life Sciences
© 2008 PTC
30
Example: Boston Scientific Implementation of Arbortext
Technical Communications / Product Labeling Overview
Technical Communications produces the
primary literature and labeling for Boston
Scientific CRM
•
System Guides (~300 pg)
•
Physician Technical Manual (~30-60 pg)
• 12 authors
•
Physician Lead Manual (~30-60 pg)
• 5 translation associates
•
Operators Manual (~30-60 pg)
• 2 PLCMS business analysts
•
Warranty (~1-3 pg)
• 1 PLCMS system analyst
•
Box and Tray Label (~2 pg)
•
Patient Handbook (~30-60 pg)
•
Instructions for Use (~1-30 pg)
•
Patient Manuals (~4-30 pg)
•
Errata Sheets (~1-5 pg)
•
Clinician Manuals (~30-60 pg)
Primary literature and labeling:
•
CRM product literature and labeling include:
Provides information regarding the safe
use of their devices
•
Acts as the foundation for regulatory
approvals
•
Provides the basis for marketing claims
Life Sciences
Product Labeling is used by:
• Physicians
• Clinical Studies
• Marketing
• Nurses
• Software Engineering
• R&D
• Patients
• Technical Services
• Sales Training
• Regulatory
• System Engineering
• Legal
31
Traditional vs. Structured Authoring (Arbortext)
Word Processing
Centered, 24pt, Bold
Book Antiqua
Centered, 20pt Arial
Arboractin-D
Drug Name
Arborex sodium
Generic Name
Extended release tablets
Formulation
60 mg and 120 mg
Left Justified, 20pt,
Book Antiqua Bold
Body Text, 10pt Book
Antiqua
Indent 2X, 20pt Book
Antiqua Italic
XML Content
Strength
Description
Description Section
This is Arboraction-d (arborex sodium) in extended
release tablets in 60 and 120 mg strengths.
Paragraph
Clinical Pharmacology
This is Arboraction-d (arborex sodium) in extended
release tablets in 60 and 120 mg strengths.
Clinical Pharmacology Section
Paragraph
Indications and Usage
For the treatment of high blood pressure. 1-2 Tablets a
day as directed. Not for use by children under 18.
Contraindications
Pregnancy
Nursing Mothers
Indications Section
Paragraph
Contraindications Section
Contraindications List
Life Sciences
32