agenda
DESCRIPTION
Agenda. Regulations & Standards Compliance Medical Industry. Compliance – Regulatory & Standards. Compliance – Regulatory & Standards. ISO – International Standards Organization CFR – Code of Federal Regulations SQF – Safe Quality Foods ANSI – American National Standards Institute - PowerPoint PPT PresentationTRANSCRIPT
Regulations & Standards
Compliance
Medical Industry
Agenda
Compliance – Regulatory & Standards
Manufacturing / Distribution
ISO 9000:2000
ISO 9000:2008
Compliance – Regulatory & Standards
ISO – International Standards Organization
CFR – Code of Federal Regulations
SQF – Safe Quality Foods
ANSI – American National Standards Institute
OSHA – Occupational Safety & Health Administration
FAR – Federal Acquisition Regulation
FAA – Federal Aviation Administration
SARA - Superfund Amendments and Reauthorization Act
REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals
Compliance – ISO StandardsSect
Function Where Sect
Function
4.23 Document Control 8.22 Internal Audits
4.24 Quality Records 8.2.3
Measuring Processes
5.6 Management Review 8.2.4
Measuring Product
6.0 Resource Management 8.3 Control of NC’s
7.0 Product Realization 8.4 Analyzing Data
7.2 Customer Related Process 8.51 Continual Improvement
7.4 Purchasing 8.52 Corrective Actions
7.5 Control of Production 8.53 Preventive Actions
7.6 Control of Monitoring &Measuring Devices
8.21 Customer Satisfaction
Regulations & Standards
•Traceability through all functional actions•Recall protection•Quality•Electronic records & audit trails•Validation
Compliance
•Business process management•Workflows and approvals with business rules•Security administration•Electronic signatures with notifications
Control
Simply Smarter
Business SolutionERP QMS CRM REPORTING
ComplaintsNon-
Conforming Materials
Calibration &
Maintenance
Regulatory Requirement
s
AuditsMaterial Returns
Product Data Management
Supplier Management
Safety Meetings
MO
NIT
OR
Quality Records
Employee Training
DeviationsChange Management
Document Control
INVESTIGATIONS
CAPACorrective &
Preventive Actions CO
NTR
OL
cGMP
HACCPFDA
ISO
PART 11 SOX
Inspections
Simply Smarter
Business SolutionERP QMS CRM REPORTING
ComplaintsNon-
Conforming Materials
Calibration &
Maintenance
Regulatory Requirement
s
AuditsMaterial Returns
Product Data Management
Supplier Management
Safety Meetings
Quality Records
Employee Training
DeviationsChange Management
Document Control
INVESTIGATIONS
CAPACorrective &
Preventive Actions
Alerts
Charts
Dashboards
Mobile Access
Inspections
Escalations
E-Signature
Audit Trail
Security
Integrated Quality Solution
Quality for SYSPRO’s quality management software system consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), and other documents- and forms-based quality and business processes.
Document Control
Document control manages the creation, approval, distribution and archiving of all controlled documents, such as manuals, procedures, work instructions, forms, job descriptions, product specifications, inspection specifications, test methods, and much more. Any document used in the application of any ISO standard must be controlled by means of a quality management system (QMS) specific to the company.
A controlled document may be stored electronically, on a disk, on paper, or as a photograph. The QMS ensures each document's integrity by adhering to specific rules for document use and storage.
Non ConformanceA non-conformance means that something went wrong – a problem has occurred and needs to be addressed. Product characteristics are not to specification. You may find a non-conformance in a service, a product, a process, from a supplier, or manufacturing process system itself. It occurs when something does not meet the specifications or requirements in some way.
Those requirements might be defined by the customer, a regulatory body, or in the internal procedures of the company. A non-conformance could be identified through customer complaints, internal audits, external audits, incoming material inspection, and manufacturing or simply during normal testing and inspection activities.The non-conformance procedure will address how you deal with the
problem:
How to decide on what immediate actions will be taken to correct the problem, and who is responsible for the decision.Assess the effects of the problem – how much, how bad (e.g. scrap/rework)Contain the effects – (e.g. quarantine/MRB defective itemsNotify affected customersStop further non-conformance
Corrective ActionCorrective actions are reactive – something has gone wrong and these are the actions taken to deal with the problem. Non-conformances are resolved through corrective actions.This will include the immediate corrective actions you take to keep your customer happy, e.g. you sent the wrong part and will immediately replace it with the correct part.
The problem might be identified in processes, materials, suppliers, the product, the service, the workplace, or the management system itself.
The Corrective Action procedure will include the steps taken to:
Review and document the problemContain or temporarily fix the problem e.g remove the defective product from production and quarantine it in a designated area for later investigationInvestigate the cause of the problem – how did it happen, why did it happen, could it happen again?Propose an appropriate solution that will prevent the problem happening again. This will often mean a change to the process. You need to report on what actions were actually takenAfter an appropriate period of time, you will need to assess whether the actions taken were successful in preventing recurrence. Document the evidence to support your decision.
Education & Training
Employee Training module helps to manage the identification, responsibilities, authorities, and training and certification requirements for each employee in an easy-to-use environment. This provides a simple way to schedule and record training.
Manage the following:
Streamline training communicationWritten job descriptions and their competenciesCreate course profilesIdentify course prerequisitesDefine pass/fail criteriaDefine expiration date and receive notificationsHandles internal and external trainingIdentify qualified trainers based on coursePaper or electronic copies of licenses, certificates, training records, etc.Gap analysisTraining Schedule with plan Controls the training records once employee training is completedLinked to Document Control
Inspections
Build a database of Inspection Specifications, detailing all product characteristics, inspection rates, and then record the results with the inspection record is being performed.
Manage First Article, In-process, Final and Receiving Inspection results, and other user-definable inspection activity.
Manage the following:
Automate the inspection processGenerate inspection documentationSetup control level warningsIdentify Tooling/Equipment required Track inspection time/costAssociate unlimited attachmentsGenerate Non-conformance
AuditingAn audit is simply another form of inspection and testing – except that in this case the product being inspected is the management system itself. There are two basic audits, internal and external. Internal is auditing the companies own processes, while External audits manage and control your Suppliers.
Audits are performed to ensure that suppliers (or prospective suppliers) systems, practices, and procedures are defined, documented, controlled and periodically assessed for effectiveness and compliance. Audits are also conducted as pre-award survey to assess supplier capabilities and qualifications needed to meet specific client contractual obligations.
Audits help uncover areas that are in need of attention. Quality, safety and environmental management standards all require audits to monitor and report on the effectiveness of the management system.
Supplier ManagementYou should evaluate and select suppliers based on their ability to meet your requirements.You have to define the requirements that are important to your organization, and select suppliers on those criteria. The list of approved suppliers is part of your quality management system.
Evaluation CriteriaObviously cost is an important criterion for selecting a supplier, but it shouldn’t be the only factor – or even the most important one.A reliable and consistent supplier is worth paying extra for, since the less variation coming into your process; the easier it is to keep consistent results. It’s not just the product you need to think about – consistent lead times, good customer support, delivery, and business stability are important too.
Evaluation MethodsSome companies use a questionnaire form with new suppliers, while others deem best to perform a physical audit of the suppliers facility.
For existing suppliers, you will need to periodically re-assess whether your suppliers are still meeting your needs. To evaluate suppliers based on their past performance, you’ll need to keep records (e.g. an Incoming product inspection log, records of supplier non-conformance).
Tooling & Equipment
Schedule and record the results of all your calibration activities and costs for each piece of equipment. Maintenance or Repair tickets can be scheduled independently and easy-to-read reports and automatic notifications indicate when equipment is due for calibration/maintenance. R&R studies can also be done quickly and uniformly.
Maintenance is an intuitive, easy and effective way of recording and tracking equipment that requires preventive and reactive maintenance. Complete with work orders, this module is easy and powerful, minimizing operator input during normal and repair operations.
MEDICALKey Provisions
21CFR part 1121CFR part 820(GMP)ISO 13485/9001Recall managementValidation
Industry Information
DefinitionClassification ControlsClassification Breakdown
Definition
A Medical Device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals.
Definition
One end of spectrum - highly invasive and technologically complex products
Electrically active implantable products Pacemakers Artificial cochlear devices Implantable neurotransmitters
Non-active implantable devices: Coronary stents Spine screws Knee or hip replacement devices
Definition
Other end of spectrum – simple consumer items BandagesDressings and drapesDisposable surgical instruments / syringesBarrier contraceptives – such as condoms
Diagnostic & surgical equipment also regulatedMRI imaging machinesElectro-cautery devicesECG monitors
Classification
Stringency of regulation depends on “Class” of the device being produced
Three Classes:Class I – General ControlsClass II – General Controls with Special ControlsClass III – Pre-Market Approval
Classification Controls
Class I General ControlsPresent minimal potential for harm to the user
Subject to the least regulatory controls
Controls cover:Register manufacturing and distribution locationsList device to be marketed with FDAManufacture in accordance with good manufacturing practices Label in accordance with labeling regulations
21 CFR 801 21 CFR 809
Report adverse events
Typical Class I products:Tongue depressorsArm slingsStethoscopesElastic bandagesExamination glovesHand-held surgical instrumentsOther similar types of common equipment
Classification Controls
Class II General Controls with Special ControlsClass II devices are held to a
higher level of assurance than Class I
The must perform as indicatedPose mild potential risk
Additional special controls include:Special labeling requirementsMandatory performance standardsPost market surveillance
Typical Class II products:X-ray machinesPACSPowered wheelchairsInfusion pumpsSurgical drapesSuture materialsAcupuncture needles
Classification Controls
Class III Pre-market Approval
Class III is most stringent regulatory category
Devices in this category usually:Require pre-market approvalSupport or sustain human lifeFull description on intended use including the manufacturing, processing, packing and installation Performance standards to ensure device meets each standard
Require additional regulation to assure safety and effectiveness
Typical Class III products:Heart valvesPacemakersSilicone gel-filled breast implantsJoint replacementsImplanted cerebella stimulators
Classification Breakdown
868 Anesthesiology870 Cardiovascular862 Clinical Chemistry and Clinical Toxicology872 Dental874 Ear, Nose, and Throat876 Gastroenterology and Urology878 General and Plastic Surgery880 General Hospital and Personal Use864 Hematology and Pathology866 Immunology and Microbiology882 Neurology884 Obstetrical and Gynecological886 Ophthalmic888 Orthopedic890 Physical Medicine892 Radiology
FDA established classifications for 1700 different generic types of devices and grouped into 16 medical specialties
Referred to as panelsAssigned to one of three regulatory classes based on level of control
Class device assigned to determines the type premarketing submission/application required for clearance
Class II a 510(k) will be required for marketingClass III requires a premarket approval application (PMA)
Classification Breakdown
21 CFR Part 11 Electronic Records; Electronic signatures
Subpart A – General Provisions
Subpart B – Electronic Records
Subpart C – Electronic Signatures
21 CFR Part 11
Subpart A – General Provisions
Subpart B – Electronic Records
Subpart C – Electronic Signatures11.1 Scope
11.2 Implementation
11.3 Definitions
11.10 Controls for closed system
11.30 Controls for open system
11.50 Signature manifestations
11.70 Signature/record linking
11.100 General requirements
11.200 Electronic signature components and controls
11.300 Controls for identification codes/passwords
Requirements for ComplianceTechnical controls
Data validation
Audit trails
Time stamps
Security
Record maintenance
Electronic signatures
Administrative controls
Notifications
Training
Standard Operating Procedures
What makes SYSPRO Compliant
Audit TrailsJob loggingAmendment journalsRecord archivingSecurityRole based accessPassword control & configurationProgram accessSystem audit logElectronic SignaturesSignatures auditSYSPRO Workflow ServicesSequencing of steps SYSPRO Reporting ServicesArchiving utilities
21 CFR Part 11 Electronic Records; Electronic signatures
Subpart B – Electronic Records
11.10 Controls for Closed system
11.30 Signature Manifestations
11.50 Signature/record linking
11.10 b Controls for a Closed System (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
SYSPRO Reporting ServicesForms & ReportsForm DesignersReport OutputXML Viewing
11.10 c Controls for a Closed System (b) Protection of records to enable their accurate and ready retrieval throughout the records retention period.
Archive and Retrieve Documents
SYSPRO Reporting Services
Archive Output to .pdf Encryption
11.10 d Controls for a Closed System(d) Limiting system access to authorized individuals.
SYSPRO SecurityDefinitionAlternate passwords & configurationLogin attempts & lockout controls
11.10 d Controls for a Closed System(d) Limiting system access to authorized individuals.
SYSPRO SecurityRole, operator, group, companyeSignaturesProgram AccessActivities and fieldsAccess Control
11.10 e Controls for a Closed System(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for as long as it is required for the subject electronic records and shall be available for agency review and copying.
System audit logsJob logging
Time stampsAmendment journals
11.10 e Controls for a Closed System(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for as long as it is required for the subject electronic records and shall be available for agency review and copying.
Amendment journals
11.10 f Controls for a Closed System(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.
SYSPRO Workflow ServicesProcess sequencing
Approvals and Rejections
11.10 g Controls for a Closed System(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand.
Password Controls128 byte encryptionPassword agingPassword recycling
Login controls Login attempts Lockout accounts Idle accounts Automatic sign-out
11.10 i Controls for a Closed System(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks
On-line education system - SLCNew employees trainingExisting employee reviewNew module how-to
Training & Certification - uniPointNew employees training recordsExisting employee review
11.50 a Signatures/Record Linking(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
Electronic Signatures
(1) The printed name of the signer;
(2) The date and time when the signature was executed; and
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
11.70 a Signatures/Record Linking
Password Setup
Electronic Signatures
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.
11.200 Electronic Signatures Components
Password Setup/Alternate Password
11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:
(1) Employ at least two distinct identification components such as an identification code and password.
21 CFR Part 11
21 CFR Part 820 Quality System Regulation
Current Good Manufacturing Practices
SYSPRO and uniPoint
Part 820 Breakdown
21 CFR Part 820Subpart A General Provisions
§820.1 Scope§820.3 Definitions§820.5 Quality system
Subpart B Quality System Requirements
§820.20 Management responsibility§820.22 Quality audit§820.25 Personnel
Subpart C Design Controls§820.30 Design controls
Subpart D Document Controls§820.40 Document controls
Subpart E Purchasing Controls§820.50 Purchasing controls
Subpart F Identification and Traceability
§820.60 Identification§820.65 Traceability
Subpart G Production and Process Controls
§820.70 Production & process§820.72 Inspection, measuring & test equipment§820.75 Process validation
Subpart H Acceptance Activities§820.80 Scope§820.86 Receiving, in-process and finished device acceptance
Subpart I Non-Conforming Product§820.90 Non-conforming product
21 CFR Part 820
Subpart J Corrective & Preventive Actions
§820.100 Corrective & preventive actions
Subpart K Labeling & Packaging Control
§820.120 Device labeling§820.130 Device packaging
Subpart L Handling, Storage, Distribution & Installation
§820.140 Handling§820.150 Storage§820.160 Distribution§820.170 Installation
Subpart M Records§820.180 General requirements§820.181 Device master record§820.184 Device history record§820.186 Quality system record§820.198 Complaint files
Subpart N Servicing§820.200 Servicing
Subpart O Statistical Techniques§820.250 Statistical techniques
SYSPRO Tools
PurchasingInventoryReceiving inspectionApproved vendorReturn to vendorSupplier performance
Design ControlsCAD integrationBill of materialEngineering change
Identification & TraceabilityLot/serial controlComponent to parentUp & down query
Production and Process ControlsWork in progressWIP inspection
ServicingReturned merchandiseCRM – Field ServiceTransaction posting – Depot
Electronic recordsFactory documentationRecord archiving
Integrated Quality Solution
Quality for
SYSPRO
Non-Conform
anceCorrective Actions
Document
Control
Audit
Tooling &
Equipment
Supplier Manage
ment
Inspections
Education &
Training
Document Control
Education & Training
Non-conformance
Corrective Action
Tooling & Equipment
Inspections
Audits
Supplier ManagementSurveys
(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.
(c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.
(i)Device history record (DHR ) means a compilation of records containing the production history of a finished device.
(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.
(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.
(m)Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.
21 CFR Part 820 - Subpart AGeneral (§820.3) Definitions
(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.
(q)Nonconformity means the nonfulfillment of a specified requirement.
(t)Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.
(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management
21 CFR Part 820 - Subpart AGeneral (§820.3) Definitions
(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.
(y)Specification means any requirement with which a product, process, service, or other activity must conform
21 CFR Part 820 - Subpart AGeneral (§820.3) Definitions
Design Controls(§820.30)Any class III, class II, and some class I (820.(a)(2))
21 CFR Part 820 - Subpart C
21 CFR Part 820 - Subpart C
General (§820.30a)Design and development planning (§820.30b)Design input (§820.30c)Design output (§820.30d) SOPDesign review (§820.30e) SOPDesign verification (§820.30f) SOPDesign validation (§820.30g) SOPDesign transfer (§820.30h) SOPDesign changes (§820.30i)Design history file (§820.30j)
Document Controls(§820.40)
Document Approvals (§820.40a)Review and approve prior to issuanceAvailable at all locations necessaryRemove obsolete documents promptly
Document Changes (§820.40b)Original review and approvalTimely communication of changesChange records with approvals
21 CFR Part 820 - Subpart D
Purchasing Controls (§820.50)Raw material receiptsRaw material inventoryAllocation/transfer of materialsIncoming quality auditsSupplier quality ratingsNon-conforming material segregation
21 CFR Part 820 – Subpart E
Integrated Quality Solution
Quality for SYSPRO’s quality management software system consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and forms-based quality and business processes.
21 CFR Part 820 – Subpart ESupplier Management
Optionally places Supplier on Hold if their Approval has been rejected in the Ratings Module.
Purchase orders
Automatically associate an inspection specification for merchandise line(s) requiring inspection.
Requisitions created to generated Purchase Orders
Requirement planning generated orders will automate the process by capturing the inspection specification for every inspection item on that purchase order
Purchase orders received into inspection
An inspection record is generated in uniPoint at the time of receipt.
Lot/Serial generated along with the GRN
Notifications can flag quality operators of pending inspections.
Purchase orders Inspection Completed
Dynamically pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO PO on Inspection completion
Dynamically pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO PO on NC completion
Dynamically updates Purchase Order GRN
21 CFR Part 820 – Subpart E
Take Action
Pass
Fail
Record Inspection
Results
Print Inspection
Record
Inspect Materials
Receive to FG
PrintRejection
Documents
Create Purchase Order
Quarantine Materials
Receiving Documentation
Receive GoodsElectronic Signature
Inspection Document
Language Translation
uniPoint Inspection Electronic
Signature
Require NC
Yes
Generate NC
Electronic Signature
21 CFR Part 820 – Subpart E
Reads uniPoint Inspection Specifications
Purchase Order Generated
Inspection Specification Matrix
Stock CodeSupplierCustomer
Purchase Order Generated
Inspection Specification written back to the SYSPRO PO merchandise lineReads uniPoint
Inspection Specifications
Inspection Record dynamically created
Lot/Serial generated along with the GRN
Inspection record generated and the above details passed
Inspection record dynamically placed on the Inspectors To-Do List
Purchase Order Received
Purchase Order Inspection
Inspection Record Completed
Option to pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO PO on Inspection completion
Option pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO PO on NC completion
Inspection Record number written to Purchase Order Inspection
Dynamically updates Purchase Order GRN
21 CFR Part 820 Quality System Regulation
Quality for SYSPRO in Action
Demonstration
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
Purchasing Inspection
21 CFR Part 820 – Subpart E
SOP-00058 Control of Received Materials
21 CFR Part 820 – Subpart E
SOP-00036 Supplier Qualification and Maintenance
Identification & Traceability (§820.60/65)
Unique lot numberUnique unit, lot and batchTrackingSerialization
21 CFR Part 820 – Subpart F
A device identifier, which is a unique numeric or alphanumeric code specific to a device model; anda production identifier, which includes the current production information for a device.
UDI – Unique Device Identifier
Production & Process Controls (§820.70/72/75)
Work instructions/SOP’sOperator certificationFacilitiesEquipment certificationPreventive maintenanceInspectionsValidation
21 CFR Part 820 – Subpart G
Acceptance Activities (§820.80/86)
Receiving acceptanceIn-process acceptanceFinal acceptanceAcceptance recordsAcceptance status
21 CFR Part 820 – Subpart H
These elements become part of the Device Master Record
Integration Options - Manufacturing
Bill of Material
Automatically associate an inspection specification for a Inspection operation
Work in process
Automatically associate an inspection specification for a job that requires inspection
Requirement planning generated orders will automate the process by capturing the inspection specification for each job that requires inspection.
Work In process inspection
When an operation preceding an inspection operation is completed, through labor posting(both standard and ShopClock an Inspection record will be created in uniPoint.
Job(s) are placed on hold pending completion of inspection record.
Dynamically pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on Inspection completion.
Dynamically pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on NC completion.
Dynamically update NC labor costs to Job on NC close.
Automatically create rework SYSPRO Job from NC
Jobs received into inspection
An inspection record is generated in uniPoint at the time of receipt.
Integration Options– Bill of Material Flow
Reads uniPoint Inspection Specifications
Bill of Material Generated
Operation is flagged as either “Full” or “Sample” Inspection Required
Automatically associate an inspection specification for a Inspection operation
Manufacturing Inspection
Manufacturing Inspection
Integration Options– Work in Progress Flow
Reads uniPoint Inspection Specifications
Job/Work Order Generated
Inspection Specification Matrix
Stock CodeCustomer
Job/Work Order Generated
Inspection Specification written back to the SYSPRO Job
Reads uniPoint Inspection Specifications
Inspection Record dynamically created
Operation completed and next operation is Inspection required Inspection Record generated
Job placed on hold pending inspection completion
Inspection record dynamically placed on the Inspectors To-Do List
Labor PostingShop Clock or SYSPRO
Job/Work Order Inspection Record
Completed
Job removed from hold upon inspection completion
Option to pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on Inspection completion
Option pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on NC completion
Integration Options – Work in Progress Flow
uniPoint Inspection Record Generated
Job/Work Order Receipted
Dynamically generated Inspection Record and placed on the Inspectors To-Do List
WIP Inspection UpdatedInspection Record
Completed
Option to pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on Inspection completion
Option pass “accepted”, “scrap”, and “rejected” quantities to SYSPRO Job on NC completion
Dynamically update NC labor costs to Job on NC close.
21 CFR Part 820 Quality System Regulation
Quality for SYSPRO in Action
Demonstration
Manufacturing In Process Inspection
Manufacturing In Process Inspection
Manufacturing In Process Inspection
Manufacturing In Process Inspection
Manufacturing In Process Inspection
Manufacturing Final Inspection
Manufacturing Final Inspection
Manufacturing Final Inspection
Manufacturing Final Inspection
21 CFR Part 820 – Subpart I & J
Non-Conforming & Corrective Action (§820.90/100)
Non-conformance tracking & CAPA generation Root cause analysisCorrective action approval & implementationRework evaluation
These elements become part of the Device History Record
Device Labeling (§820.120)Label integrityLabeling InspectionLabeling StorageLabeling operationsControl Number
21 CFR Part 820 – Subpart K
A device identifier, which is a unique numeric or alphanumeric code specific to a device model; anda production identifier, which includes the current production information for a device.
UDI – Unique Device Identifier
Must be compliant by September 24, 2014 through 2020
FDA Harmonize Medical Device Labeling
The label on the package of any medical device set on the market will show the symbols in compliance with the harmonized standards.The symbols marked with a single (*) are based on the ISO 21531, ISO 15223-1, EN 980 European Standard and on the 93/42EEC Directive
21 CFR Part 820 – Subpart K
Device Master Record (§820.180)
Electronic recordsRetention periodDevice specificationsProduction process specification
21 CFR Part 820 – Subpart M
Device specificationsProduction process specificationsQuality assurance procedures and specificationsPackaging and labeling specificationsInstallation, maintenance and servicing procedures and methods
Device master record (DMR) means a
compilation of records containing the
procedures and specifications for a finished
device.
21 CFR Part 820 – Subpart M
These elements become part of the Device Master Record
21 CFR Part 820 – Subpart M
These elements become part of the Device Master Record
Device History Record (§820.181)
Data for each unitSignatures captured
21 CFR Part 820 – Subpart M
Dates of manufacture
Quantity manufactured
Quantity released for distribution
Acceptance records which demonstrate the device is manufactured in accordance with DMR
DHR shall include:
‒ Production Run Sheets
‒ Travelers
‒ Process Control Records
‒ Environmental Monitoring Records
‒ Quality Assurance Test Runs
21 CFR Part 820 – Subpart MWhat purpose do DHRs serve for the device manufacturer?
- Serves as the basis for product evaluation
- Traceability and tracking (products and components)
- Trending of quality data
- Record of changes or variances in a process
- Problem solving (facilitates investigations,
corrective actions, etc.)
21 CFR Part 820 – Subpart M
What purpose do DHRs serve for the FDA?
- Provides objective evidence that a firm’s procedures and processes were followed, and that the requirements of the DMR were met.
- Serves as a data source for a firm’s overall manufacturing “state of control”
- Evaluation of a firm’s investigations and corrective and
preventive actions
- Ensures label and labeling control for products
21 CFR Part 820 – Subpart M
Complaint Files (§820.198)Reportable vs Non-reportableInvestigation requiredMedWatch – Form FDA 3500B
21 CFR Part 820 – Subpart M
21 CFR Part 820 – Subpart M
21 CFR Part 820
Validation
System Validation Master Plan
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
IQ
OQ PQ
SYSPRO
Validation Assistance – SYSPRO Tools
Process validation is applied to the specific needs of each SYSPRO user company
Each validation is unique
Many factors influence the actual validation process
Number and types of manufacturing steps and transactions
We provide:
Documentation for SYSPRO
Guidance and support in the preparation and conduct of the validation
Validation Assistance – SYSPRO Tools
SYSPRO Process ModelingPolicies and ProceduresReference MaterialTraining MaterialValidation Scripts/ModuleWorkflow
Business Process Management
SYSPRO Process ModelingSYSPRO Process Modeling Internal Control Documents
Policies and Procedures
Policies and ProceduresEstablishment and controlLink to Training RecordsLinked to Processes
Reference Material
Reference MaterialOn-line and Printable Link to Training Records
Training Material
Training MaterialOn-line and Printable Link to Training Records
Validation Test Scripts
Validation
Each process has its own test script
The following test procedures describe:
The setup requirements as described in the Software Requirements Specification (SRS) revision A for SYSPRO
All necessary steps for conducting each test.
As each test procedure is completed, it will be signed off and marked as passed or failed by the tester. This will serve as a log of completed test procedures.
Validation Test Scripts
The uniPoint Validation module is a tool to help automate the recording of validation procedures and actual results, as it pertains to uniPoint Software, or other software or process validation projects.
Workflow Services
SYSPRO Workflow ServicesProcess sequencingLimit functionsApprovals and rejections
SYSPRO Medical Solution
Test Script
SYSPRO Medical Solution
Test Script
SYSPRO Medical Solution
Test Script
SYSPRO Medical Solution
Test Script
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uth
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