This presentation provides an overview of the role that a computerized quality management system plays in a manufacturer practising Good Manufacturing Practices and compares it's complimentary functions against an Enterprise Resource Planning System

1. Quality Management
Systems for Medical,
Pharmaceutical, Cosmetic
and Food Products
And their differences with ERP Systems

2. Background
Requirements for Quality Management Systems

3. Regulations and Regulators
 Europe – Directive 2003/94/EC (EU
Regulators)
◦ GMP: “the part of quality assurance which ensures
that products are consistently produced and
controlled in accordance with the quality standards
appropriate to their intended use”
 USA – F,D&C Act, Federal Codes (FDA)
◦ “… the minimum current good manufacturing
practice for … the manufacture, processing,
packing, or holding of a drug to assure [safety,
identity, strength, quality and purity]”

4. The GxP’s
 “Good x Practice”
◦ Good Clinical Practice
◦ Good Distribution Practice
◦ Good Laboratory Practice
◦ Good Manufacturing Practice
 GxP Controls to are required to minimize
risks to
◦ Patient Safety
◦ Product Quality
◦ Data Integrity

5. Objective
 “Our primary focus will remain the same:
to minimize the risks to the public health”
 - Department of Health and Human
Services, U.S. Food and Drug
Administration

6. Laws, Regulations and Guidance
 Law, e.g.
◦ Food, Drug & Cosmetic Act, EU Directive
 Regulations, e.g.
◦ 21 CFR 211, 21 CFR 820, EU GMPs
 Guidance, e.g.
◦ FDA Guidance on Part 11 Scope and Application

7. The Food, Drug and Cosmetic Act
 “A drug or device shall be deemed to be
adulterated … if it is a drug and the methods
used in, or the facilities or controls and the
methods used in, or the facilities or controls used
for, its manufacture, processing, packing, or
holding do not conform to or are not operated or
administered in conformity with current good
manufacturing practice to assure that such drugs
meet the requirements of this chapter as to
safety and has the identity and strength, and
meet the quality and purity characteristics, which
it purports or is represented to possess…”

8. 21 CFR 211.68 Automatic,
Mechanical and Electronic
Equipment
 Must
◦ Perform a function satisfactorily
◦ Calibrated, inspected or checked according to a
written programme
◦ Controlled in use
◦ The data is secure
◦ Outputs are accurate
◦ Adequately backed up, maintained and
documented
◦ Under change control

9. GAMP 5, ICH Q9
 “Manufacturers should be able to justify
their standards, protocols, acceptance
criteria, procedures and records based on
their risk assessment”

10. Quality Management Systems

11. Records and Signatures
 Records that are required to be maintained under
predicate rule requirements and that are maintained
in electronic format in place of paper format
 Records that are required to be maintained under
predicate rules that are maintained in electronic
format in addition to paper format, and that are relied
upon to perform regulated activities
 Records submitted to FDA under predicate rules
(even if such records are not specifically identified in
Agency regulations) in electronic format.
◦ - FDA Scope and Application Guidance

12. Elecronic Record
 Electronic record means any combination
of text, graphics, data, audio, pictorial or
other information representation in digital
form that is created, modified,
maintained, archived, retrieved, or
distributed by a computer system

13. Electronic Signature
 Electronic signature means a computer
data compilation of any symbol or series
of symbols executed, adopted, or
authorized by an individual to be the
legally binding equivalent of the
individual’s handwritten signature

14. Validation of Systems
 Validation of systems to ensure accuracy,
reliability, consistent intended
performance and the reliability to discern
invalid or altered records
 This clause is currently under enforcement
discretion

15. Protection
 Protection of records to ensure their
accurate and ready retrieval throughout
the records retention period

16. Record Retention
 Must meet predicate rule requirements
and preserve content and meaning
 Decision how should be based on
predicate requirements, a justified and
documented risk assessment, and
determination of the value of the records
over time

17. Audit Trail
 Secure, computer generated timestamped
audit trails to independently record the
date and time of operator entries and
actions that create, modify or delete
electronic records

18. Quality Management System
Quality Modules
• Risk Management
• Document Management
• Project Management
• Process Management
• IT Services Management
• Product Life Cycle Mgt
• Competency
Management
• Asset Management
• Preventive/Corrective
Actions
• etc

19. ERP
 ERP Functions
◦ General Ledger
◦ Purchasing
◦ Inventory
◦ Sales
◦ Accounts Receivables
◦ Accounts Payables
◦ Production Planning & Control
 Logistics
 Production Schedule
 Job Costing
◦ etc

20. Differences
Quality Management Systems ERP Systems
Data related to Quality Management
• Quality documents, policies, SOP,
procedures, checklist
• Project plans eg product lifecycle
management activities: prepare specs,
drawings, acceptance, tooling, training
• Quality related workflows
• Preventive/ corrective actions:
equipment maintenance, customer
complaints, incoming QC
• Risk management – identification,
quantification, control plan, monitoring
• Quality related KPIs – reworks,
downtime, deadlines
• Staff training – evaluation, training
needs, scheduling, certification
Financial, manufacturing and logistic data
• Order entry, deliveries, sales invoicing,
accounts receivables
• Purchase requisitions, purchase orders,
deliveries, accounts payables
• Cash and payment management, bank
reconciliation, cashflow reporting
• Manufacturing plans, production
scheduling
• Inventory management, receipts,
issuance, stock levels, transfers
• Facility management, fixed asset
register, acquisitions, disposals,
depreciation
• Human resource management, payroll,
taxes

21. Comparison of ERP to Quality
Management System
 Quality Management Systems
complement ERP Systems
 Quality Management Systems manages
quality documents, processes, people,
facilities and assets, materials
 ERP systems manages accounting and
logistics aspects of finance, production,
inventories

22. Enterprise Quality Management

23. Governance, Risk and Compliance

24. Enterprise Risk Management

25. Environment, Health and Safety

26. Document Management

27. QMS and ERP Integration

28. Integrated Solution Architecture
Data
Synchro
nization
with
ERPIntegration

29. Integration Points – Core Module
 Personnel – staff/user id, departments,
teams, positions, roles
 Business Units, Organization Units
 Business Calendar

30. Process Integration – Sales/ Production
Predefined
Parts
Custom
Order
Production
Sales
Support
QMS ERP
• Specifications Docs
• Drawings
• Project Planning
• Specifications/
Drawings – Revision
Control/ Acceptance
• Commercial Proposal
Docs
• Change Management
• Quality Records
• Quality KPIs
• Process Risks
• Logistics Document
Capture/ Storage
• Corrective Actions
• Parts Definitions
• Parts Details/ Std
Costs
• Sales Quotation
• Order Entry
• Subcontractors
Quotations
• Credit Control
• Production Planning/
Control
• Inventory
• Cost Accounting
• Delivery Order
• Invoicing
• Accounts Receivables

31. Integration Points - Production
 Item types
 Part numbers
 Part details eg descriptive details, alias
names
 Equipment ID
 Process/ Run / Batch ID and details
 Customer names and details
 Subcontractor names and details (if
applicable)

32. Item
Definitions
Purchase
Order
Delivery
Inventory
Management
Process Integration – Purchasing/ Inventory
QMS ERP
• Specifications Docs
• Drawings
• Document
Management
• Request
Documents
• Suppliers
Proposals
• Change Management
• Delivery Documents
• Incoming Inspections
• Quality Checks
(Expiry/
Deteriorations)
• Parts Definitions
• Parts Details/ Std
Costs
• Supplier Quotation
• Purchase Order Entry
• Delivery Tracking
• Inventory Receiving
• Supplier Invoices
• Accounts Payables
• Inventory Records
• Stock Taking
• Stock Movements

33. Integration Points - Inventory
 Inventory types, inventory item ID,
storage locations
 Supplier names and details
 Shippers names and details

34. Acquisition
Planning
Fized Assets
Acquisitions
Delivery/
Installation
Operations/
Maintenance
Process Integration – Fixed Assets
QMS ERP
• Specifications Docs
• Drawings
• Budgetary
Documents
• Change Management
• Tender Documents
• Contract Documents
• Delivery Documents
• Incoming Inspections
• Test/ Commissioning
Reports
• Correctuve Actions
• Calibration
• Preventive/
Corrective
Maintenance
• Parts Definitions
• Parts Details/ Std
Costs
• Supplier Quotation
• Purchase Order Entry
• Delivery Tracking
• Inventory Receiving
• Supplier Invoices
• Accounts Payables
• Inventory Records
• Stock Taking
• Stock Movements

35. Integration Points – Fixed Assets
 Equipment ID and details
 Supplier ID and details
 Maintenance service providers ID and
details
 Maintenance/ calibration records and
schedules

36. Conclusion
And Benefits

37. Impact of Quality Management
Systems
•US FDA Regulations
•EU Directives
•GMP Requirements
•Other Legal and Regulatory RequirementsCompliance
•Available When Neeeded
•Secured Access
•Document Loss/ Tampering
•Non-RepudiationEffectiveness
•Loss of Business/ Opportunities
•Inability to Access Market
•Inability to Enforce Contracts & Agreements
•Inability to Defend Against Litigations & Suits
Risk
Management
•Search & Retrieval
•< 10 mins 75%
•< 1 hour 25%
•Sharing/ Alert
•Storage Utilization
Efficiency