4Life Sciences Pharma Whats 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. Pharma MFG MPMLink MPR BPR Master
Checklists Risk WC PDMLink Store BOMs which include Documents and
Parts WC PDMLink Store BOMs which include Documents and Parts QMS
Deviations, Complaints, CAPAs, Audits, and Training QMS Deviations,
Complaints, CAPAs, Audits, and Training WC ProjectLink NPI and
Automation of that Process WC ProjectLink NPI and Automation of
that Process Arbortext Structured Product Labeling and Submissions
Arbortext Structured Product Labeling and Submissions Asset
Preventive Maintenance and Calibration Asset Preventive Maintenance
and Calibration Change Management Design and Process Control Change
Management Design and Process Control Connects the quality efforts
of cross- functional teams Provides a single source of truth to
improve management visibility Unites product development activities
addressing quality Benefits RISK REPORTING
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5Life Sciences Pharma MFG Process Flow Diagram Quality
Governance Quality Execution Quality Planning Program Start Drug A
MPR Version 201 Mfg Batch Production Record (BPR) Template BPR
Checklist 201 Drug A - Lot 1 Drug A - Lot2 Complete BPR Checklist
for Each Lot Batch History Record Forms & Reports Drug Master
File Quality Governance Design Validation SOP Management Quality
Management Reporting / Dashboards Master Production Record (MPR)
Master Production Checklist Failure Reporting / Complaints
Deviation Process Analysis & Feedback (SPC) Corrective and
Preventive Action (CAPA) Failure Analysis Root Cause Analysis Lab
Information Management (LIMS) Specification Tests CTQ Validation,
Tracking Yield Verification Samples, Execution Maintenance Policies
and Spares Planning Preventative Maintenance Calibration Asset MFG
Critical Process Control (CPP) Material List Control Plans
Manufacture Integrate Engineering, Production, Chemistry, QA &
RA Validate Solution Conformance Operation Steps Final Retention
Samples Change Management Closed-loop Integration Incorporate
Identified Changes Store, Communicate Feedback to Other Lifecycle
Stages Configuration Management with BPR and MPR Temporary Process
Change (TPC) Permanent Process Change (PPC)
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6Life Sciences Windchill Overview Service Information Product
Analytics Engineering Calculations Requirements Management
Manufacturing Process Mgmt. Supplier & Component Mgmt.
Distributed Collaboration Visualization Heterogeneous CAD Data Mgmt
Change & Config. Mgmt Complete BOM Management Workflow MCAD /
CAM / CAEECAD Cadence, Mentor, Zuken Open Source, Rational
Communities of Practice Program Portfolio/ Project Management
Product Lifecycle Management Document Management ECAD Data
Management Enterprise Interoperability ERP SAP, Oracle, Dynamics
Windchill MathcadRequirementsLink Windchill PPM/PM Pro/ENGINEER
Digital Mockup ProductView Arbortext Windchill Quality InSight
Windchill MPMLink Windchill PartsLink Financials SCM MRP Embedded
Software Quality, Risk & Reliability Mgmt.
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Windchill 2006 PTC
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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
:http://sptplm.scinopharm.com.tw Development
:http://sptplmdev.scinopharm.com.tw : AD ( domain name exp
:Tommy.yang
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Windchill ( )
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QMS , , , , , pdf .exp:DMR DMR
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pdf
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Q&A
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19Life Sciences 2006 PTC Project Management (NDA, Quality
Improvement Projects and Compliance Audits) >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 A Proven Solution for Collaborative
Project Management throughout the Product Lifecycle
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20Life Sciences 20 2010 PTC Audit Execution Project Roll Up
Status Tracking
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21Life Sciences 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 Document Structure Management
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22Life Sciences Document Signature Capabilities. 21 CFR Part 11
compliant electronic signatures. Benefits Reduce compliance risk.
Reduce errors and unnecessary delays. Complete, automated tracking
and traceability. 2010 PTC 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 users 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.
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23Life Sciences 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 Earlier Input from CCB & ECCB Reduce
compliance risk. Reduce errors and unnecessary delays. Complete,
automated tracking and traceability. 2010 PTC Life Cycles are
defined by Phases and Gates. Life Cycles define an items 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. In WorkReleasedEffectiveCanceled Phase Gate State
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24Life Sciences 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.
2010 PTC 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
26Life Sciences >Design and Process FMEAs, which can have
associated Design Verification Plans (requirement fulfillment and
LIMS) and Quality Control Plans Reliability Management Manage
corrective action processes to improve reliability Assess risk and
reliability using visualization and analysis Analyze potential
failures and minimize their effects Perform reliability analyses
using globally accepted standards Analyze reliability,
availability, and cost using system modeling Analyze life data
throughout all phases of product life Predict repair times to meet
system availability objectives Analyze complex systems with state
transition diagrams Analyze the lifetime cost of a product Assess
and mitigate the risk of human errors
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27Life Sciences Correct and prevent product errors Communicate
actions to future product design Continuous product and process
improvement Why is it Important? Decentralized systems of quality
management Manual processes dont close the loop IT barriers to
configuration and implementation Common Barriers Highly structured
for repeatability of processes Trend metrics to track quality
compliance Easy-to-configure industry-proven templates PTC Benefits
Windchill CAPA: M010 CAPA - Corrective Action Preventive Action
2011 PTC
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28Life Sciences Quickly Record product nonconformances Perform
& record immediate actions Communicate lessons learned to
design Why is it Important? Labor-intensive manual intake and
reporting Tracking an issue through to its correction Losing sight
of overdue issues, quality trends Common Barriers Rapid, structured
intake & issue processing Immediate Corrections against BOM
items Full MRB & Disposition with sub workflows PTC Benefits
Windchill Nonconformance M020 2011 PTC
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29Life Sciences Users can search data with no IT help Quickly
review emerging trends Trend improvements for quality &
compliance Why is it Important? Labor-intensive manual reporting
processes Requires high degree of technical competence Losing sight
of overdue issues, quality trends Common Barriers No knowledge of
object structures required Simple Interface for simple data
questions Alerts and reports provide system insight PTC Benefits
Windchill Adhoc Reporting: M010 2011 PTC
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30Life Sciences BPR and MPR Publication Development 2008 PTC
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
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31Life Sciences Example: Boston Scientific Implementation of
Arbortext Technical Communications / Product Labeling Overview
Technical Communications produces the primary literature and
labeling for Boston Scientific CRM 12 authors 5 translation
associates 2 PLCMS business analysts 1 PLCMS system analyst Primary
literature and labeling: Provides information regarding the safe
use of their devices Acts as the foundation for regulatory
approvals Provides the basis for marketing claims CRM product
literature and labeling include: System Guides (~300 pg) Physician
Technical Manual (~30-60 pg) Physician Lead Manual (~30-60 pg)
Operators Manual (~30-60 pg) Warranty (~1-3 pg) 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) Product Labeling is used by:
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32Life Sciences Traditional vs. Structured Authoring
(Arbortext) Arboractin-D Arborex sodium Extended release tablets 60
mg and 120 mg Description This is Arboraction-d (arborex sodium) in
extended release tablets in 60 and 120 mg strengths. Clinical
Pharmacology This is Arboraction-d (arborex sodium) in extended
release tablets in 60 and 120 mg strengths. 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 Word Processing Centered, 24pt, Bold Book
Antiqua Centered, 20pt Arial Left Justified, 20pt, Book Antiqua
Bold Body Text, 10pt Book Antiqua Indent 2X, 20pt Book Antiqua
Italic XML Content Drug Name Generic Name Formulation Strength
Description Section Paragraph Clinical Pharmacology Section
Paragraph Indications Section Paragraph Contraindications Section
Contraindications List
