2. ® THIS PRESENTATION IS GENERATED TO PRESENT A
IN SIMPLE WAY HOW TO DEVELOP THE
NECESSARY AND REQUIRED DOCUMENTATION
DURING A VALIDATION & VERIFICATION
PROJECTS.
® PRESENTATION WAS MADE “IN RICE & BEANS”
LANGUAGE LIKE MY GRANDPARENT TOLD ME ALL
THE TIME.
® ALSO, EXAMPLE USE DURING THE PRESENTATION
WAS SELECTED THINKING IN THE NEW
GENERATION X.
IF YOU ARE A NEW SPECIALIST IN THE BUSINESS
WORLD AND NEED TO UNDERSTAND THE BASICS
KNOWLEDGE OF THE VERIFICATION AND
VALIDATION PROCESS.
PURPOSE
SCOPE
3. DURING THE PRESENTATION WAS USED AS EXAMPLE PHONE.
EXAMPLE
FINAL
PRODUCT
Concept
Materials
Specifcations
4. MY DEFINITIONS
• VALIDATION – TESTING TO CONFIRM AND ASSURE THAT THE SYSTEM, EQUIPMENT, FACILITY,
COMPUTER SYSTEM OR PROCESS COMPLY WITH THE REQUIREMENTS AND SPECIFICATIONS
ESTABLISHED BY THE COMPANY.
• VERIFICATION –TESTING TO CONFIRM AND ASSURE THAT THE PRODUCT COMPLY WITH THE
REQUIREMENTS AND SPECIFICATIONS.
• POLICY – BROUGHT RULES AND PROCEDURE ADOPTED BY THE BOARD OF DIRECTORS AND THE
COMPANY.
• STANDARD OPERATING PROCEDURE (SOP) – RULES AND INSTRUCTIONS DEVELOPMENT FOR
EACH BUSINESS OR FACILITY BASED ON THE COMPANY POLICY.
• WORK INSTRUCTION – SIMPLE SET OF INSTRUCTIONS FOCUS TO FOLLOW A PROCESS,
DRAWING AND/OR SPECIFICATIONS.
• TRAINING –TRAIN THE RESOURCES THAT NEED TO FOLLOW AND/OR EXECUTED A SET OF TEST
CASE, SOP OR WORK INSTRUCTIONS
5. SYSTEM LIFE CYCLE • URS
• Drawings
• Technical Doc
Requirements
• FS
• DS
• TM
Specifications
Change
Control
• IQ
• OQ
• SOP or WI
• PQ
• SOP or WI
(training)
• PV
• TM
Testing &
Report
ü DOCUMENTATION NECESSARY
AND REQUIRED FOR NEW OR
CHANGES IN THE SYSTEM,
EQUIPMENT, FACILITY, COMPUTER
SYSTEM OR PROCESS.
ü REQUIREMENTS, SPECIFICATIONS
AND TRACEABILITY MATRIX ARE LIFE
DOCUMENTS.
ü THIS DOCUMENTS NEEDS TO BE
REVIEW AND UPDATE (AS
NECESSARY) WITH EACH
APPROVED CHANGE.
6. SLC CONTINUED
v RESEARCHER AND DEVELOPMENT STAGE
WILL BE BEFORE OF THE REQUIREMENTS.
v IN MUST OF THE CASES START WITH A
NECESSITY OF A CUSTOMER/CLIENT. THE
MUST COMMON SITUATION IS THAT THE
SALE REPRESENTATIVE INFORMED THE
CONCERNED OR PROPOSED A NEW IDEA
TO THE MANAGEMENT TEAM.
v FIRST DOCUMENTATION PROJECT PLAN TO
DESCRIBE AND EXPLAINS HIGH LEVEL THE
NEW INITIATIVES AND EXPECTED GOALS
v AS PART OF THIS NEW INITIATIVES NEED A
BROUGHT TEAM MEMBERS
PRODUCT
NECESITY
CONCEPT
IDEA
7. USER REQUIREMENTS SPECIFICATIONS EXAMPLE
UR#1
MAKE AND RECEIVED CALLS
UR#2
RECEIVED AND SEND MESSAGES
UR#3
SIMPLE TO USE (USER FRIENDLY)
UR#4
LONG LIVED
UR#5
LOOKS FASHIONABLE
8. URS EXAMPLE CONTINUED
UR#6
BATTERY EFFICIENT
UR#7
COMPATIBILITY WITH THE FEATURE APPLICATIONS (APPS)
UR#8
CAMERA THAT TAKE AN EXCELLENT PICTURE AND VIDEO
UR#9
COMPATIBLE & COMMUNICATE WITH THE TABLET, COMPUTER
& WATCH
UR#10
SIMPLE ACCESS TO CALENDAR, CALCULATOR, EMAIL, WEBPAGE
& NOTES
MUSIC, BOOKS AND VIDEOS
9. FUNCTIONAL SPECIFICATION EXAMPLE
FS#1
ACCESSIBLE WAY TO MAKE AND RECEIVING CALLS THRU THE
PHONE APP.
FS#2
ACCESSIBLE WAY TO MAKE AND RECEIVING MESSAGE THRU THE
MESSAGE APP.
FS#3
PHONE NEEDS TO PROVIDE A SIMPLE WAY TO NAVIGATE THRU
THE EMBEDDED APPLICATIONS AND USE IN DAILY BASIC
FS#4
MATERIAL USED MUST PROVIDED STRONG PHONE
FS#5
HIGH END APPEARANCE, CLEAN LINES AND SIMPLE
CONFIGURATION
10. FS EXAMPLE CONTINUED
FS#6
BATTERY MUST BE PROVIDE AT LEAST 8 HOURS WITHOUT
RECHARGEABLE PROCESS
FS#7
OPERATING SYSTEM MUST BE COMPATIBLE WITH THE AVAILABLE
APPLICATIONS USED IN THE DAILY BASE
FS#8
CAMERA MUST BE TAKE PHOTO/VIDEO HIGH QUALITY,
RESOLUTION AND RAW DATA
FS#9
EACH TIME THAT THE USER DOWNLOAD A NEW APPS IN THE
PHONE THE OTHER DEVICES MUST SYNCHRONIZED AND SHOW
IN THEM.
FS#10
FACTORY CONFIGURATION AND SETTING PROVIDE THE
APPLICATIONS AS DEFAULT
11. DESIGN SPECIFICATION EXAMPLE
DS#1
FACETIME VIDEO CALLING OVER WI‑FI OR CELLULAR, FACETIME AUDIO, VOICE OVER
LTE (VOLTE), AND WI‑FI CALLING
DS#2 & 7
IOS 10: WITH AN ALL-NEW DESIGN AND ALL-NEW FEATURES, IOS 10 IS THE
WORLD’S MOST ADVANCED MOBILE OS. IT BRINGS YOUR IPHONE TO LIFE IN MORE
INTELLIGENT AND EXPRESSIVE WAYS THAN EVER.
DS#3 & 5
IPHONE 7 AND IPHONE 7 PLUS ARE SPLASH, WATER, AND DUST RESISTANT AND
WERE TESTED UNDER CONTROLLED LABORATORY CONDITIONS WITH A RATING OF
IP67 UNDER IEC STANDARD 60529. SPLASH, WATER, AND DUST RESISTANCE ARE NOT
PERMANENT CONDITIONS AND RESISTANCE MIGHT DECREASE AS A RESULT OF
NORMAL WEAR. THE HIGH-GLOSS FINISH OF THE JET BLACK IPHONE 7 IS ACHIEVED
THROUGH A PRECISION NINE-STEP ANODIZATION AND POLISHING PROCESS. ITS
SURFACE IS EQUALLY AS HARD AS OTHER ANODIZED APPLE PRODUCTS; HOWEVER,
ITS HIGH SHINE MAY SHOW FINE MICRO-ABRASIONS WITH USE.
12. DESIGN SPECIFICATION EXAMPLE
DS#4
RETINA HD DISPLAY, 5.5-INCH (DIAGONAL) LED-BACKLIT WIDESCREEN, MULTI-TOUCH
DISPLAY WITH IPS TECHNOLOGY, 1920-BY-1080-PIXEL RESOLUTION AT 401 PPI AND
1300:1 CONTRAST RATIO (TYPICAL)
DS#6
TALK TIME (WIRELESS): UP TO 21 HOURS ON 3G AND INTERNET USE: UP TO 15 HOURS
ON WI-FI
DS#8
12MP WIDE-ANGLE AND TELEPHOTO CAMERAS, WIDE-ANGLE: Ƒ/1.8 APERTURE, AND
TELEPHOTO: Ƒ/2.8 APERTURE
DS#9
SYNCING WITH ITUNES ON A MAC OR PC REQUIRES:
MAC: OS X V10.9 OR LATER
PC: WINDOWS 7 OR LATER
ITUNES 12.5 OR LATER (FREE DOWNLOAD FROM WWW.ITUNES.COM/DOWNLOAD)
DS#10
BUILT-IN APPS ARE AN ESSENTIAL PART OF YOUR IPHONE EXPERIENCE AND ARE EFFICIENTLY
DESIGNED TO USE LESS THAN 200MB OF STORAGE.
13. CHANGE CONTROL DESCRIPTION AND EXAMPLE
IN THIS POINT IS AN EXCELLENT OPTION TO INITIATED A CHANGE
CONTROL.
THE CHANGE CONTROL IS INITIATED TO EXPLAINS THE NEW OR
CHANGES IN THE SYSTEM, EQUIPMENT, FACILITY, COMPUTER SYSTEM
OR PROCESS.
IN THE CHANGE CONTROL DOCUMENT IS NECESSARY TO INCLUDED
AS FOLLOWS:
• CHANGE
• SYSTEM DESCRIPTION
• RISK EVALUATION
• IMPACT ASSESSMENT
• PLAN OR GOALS
• OUTCOME
• APPROVAL PROCESS
NOTE: CHANGE CONTROL CAN BE INITIATED FROM THE MOMENT
THAT THE PROJECT TEAM DECIDE TO START A NEW PROJECT PLAN. IS
IMPORTANT AND CRITICAL STAGE OF THE PROJECT. THIS PROCESS
DEPEND OF THE COMPANY POLICIES AND PROCEDURES.
14. PROTOCOL
DEVELOPMENT A PROTOCOL DOCUMENT TO EXPLAINS ALL THE
PROPOSED TEST CASES AND ACCEPTANCE CRITERIA USE DURING
THE EXECUTION PROCESS.
IN THE PROTOCOL DOCUMENT NEED TO INCLUDE AT LEAST THE
FOLLOWING:
• PURPOSE & SCOPE
• SYSTEM DESCRIPTION
• NEW OR CHANGES TO QUALIFIED PER CHANGE
CONTROL FORM
• TEST CASES
• DESCRIPTION
• MATERIAL
• PROCEDURE
• ACCEPTANCE CRITERIA
• REFERENCE
• ACCEPTANCE CRITERIA
• NON-CONFORMANCES EVENTS
• TRAINING
15. DEVELOPMENT A REPORT DOCUMENT TO EXPLAINS ALL THE
TESTING EXECUTION PROCESS AND RESULTS OBTAINED
FROM THE ACTIVITIES.
IN THE REPORT DOCUMENT NEED TO INCLUDE AT LEAST THE
FOLLOWING:
• SUMMARY OF THE TEST CASES EXECUTED
• RESULTS AND THE EVALUATION IN MINITAB OR
EXCEL PROGRAM
• DEVIATION, DISCREPANCIES AND NON-
CONFORMANCES EVENTS
• RECOMMENDATIONS
• CONCLUSION
TRACEABILITY MATRIX
THE INPUTS OF THIS TM ARE URS, FS, DS AND PROTOCOLS.
THIS DOCUMENT CAN BE GENERATED AFTER DESIGN
SPECIFICATION IS APPROVED AS INITIAL VERSION. AFTER
PROTOCOLS ARE COMPLETED THIS DOCUMENT NEED TO BE
UPDATED. AS RECOMMENDATION THE BEST OPTION TO
GENERATE THE TM IS IN EXCEL SPREADSHEET.
REPORT
16. TESTING EXAMPLE
GENERATE A QUALIFICATION DOCUMENT TO INCLUDE AND
EXPLAINS THE PROPOSED TEST CASES DEPEND OF THE
PROJECT STAGE.
INSTALLATION QUALIFICATION:
• DOCUMENTATION: URS, FS, DS, DRAWING, TECHNICAL
SPECS, MANUALS
• DRAWING MEASUREMENTS
• RAW MATERIAL & COMPONENTS SPECIFICATIONS
• HARDWARE INSTALLATION & SPECIFICATIONS
• SOFTWARE AND APPLICATIONS INSTALLATION &
SPECIFICATIONS
17. TESTING EXAMPLE
OPERATIONAL QUALIFICATION:
• PHONE NAVIGATION FLOW & WINDOWS
• MUST MAKE A CALLS, MESSAGE, EMAILS AND RECEIVED
• SECURITY
• SYNCHRONIZATION BETWEEN DEVICES
• DRAFT SOP VERSION
• ENVIRONMENTAL CONDITIONS
• PREVENTIVE MAINTENANCE (EQUIPMENT)
• CALIBRATIONS (INSTRUMENTS)
18. TESTING EXAMPLE CONTINUED
PERFORMANCE QUALIFICATION:
• BATTERY PERFORMANCE AND DURABILITY
• WATER PROOF FEATURE
• FACETIME CALLING
• SIRI PERFORMANCE
• CAMERA FEATURES
• SOP FINAL VERSION
PROCESS QUALIFICATION
3 LOTS IN DIFFERENT CONDITIONS
• SHIFTS
• OPERATORS
• EQUIPMENT OR MANUFACTURING LINE
19. REGULATIONS:
REGULATIONS MORE USED IN THE PHARMACEUTICAL, MEDICAL DEVICES, BIOTECHNOLOGY, AVIATION, DEFENSE INDUSTRIES AND AMONG
OF OTHERS
FOOD AND DRUG A ADMINISTRATION (FDA)
CODE OF REGULATION
HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFCFR/CFRSEARCH.CFM
GUIDANCE DOCUMENTS
HTTP://WWW.FDA.GOV/REGULATORYINFORMATION/GUIDANCES/DEFAULT.HTM
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)
QUALITY MANAGEMENT 9001:2015
HTTP://WWW.ISO.ORG/ISO/HOME/STORE/CATALOGUE_ICS/CATALOGUE_DETAIL_ICS.HTM?CSNUMBER=62085
EUROPEAN MEDICINES AGENCY (EMA)
HTTP://WWW.EMA.EUROPA.EU/EMA/INDEX.JSP?CURL=SEARCH.JSP&Q=VALIDATION&BTNG=SEARCH&MID=
AEROSPACE BASIC QUALITY SYSTEM STANDARD (AS9100C)
HTTP://STANDARDS.SAE.ORG/AS9100C/
20. QUESTIONS
• IF YOU HAVE MORE QUESTIONS AND/OR DOUBTS
PLEASE SEND ME AN INSTANT MESSAGE OR EMAIL
TO RGAMALBERT@GMAIL.COM
21. REFERENCE
• HTTP://WWW.IIGSYSTEMS.COM/PDF/VERIFICATION%20VS%20VALIDATION.PDF
• USER GUIDE HTTP://CDN.CULTOFMAC.COM/WP-CONTENT/UPLOADS/2012/09/IMG_0148.JPG
• BOOK HOW TO HTTP://FAIRERPLATFORM.COM/WP-CONTENT/UPLOADS/2012/09/IBOOKS-IPHONE-USER-GUIDE-IOS-6.JPEG
• IPHONE FOR DUMMIES 10TH EDITION BY EDWARD C. BAIG (AUTHOR), BOB LEVITUS (AUTHOR) HTTPS://WWW.FOXEBOOK.NET/IPHONE-FOR-DUMMIES-10TH-EDITION/#DOWNLOAD
• HTTP://WWW.APPLE.COM/IPHONE-7/
• FOR DUMMIES PICTURE
HTTPS://WWW.BING.COM/IMAGES/SEARCH?Q=LOGO+FOR
+DUMMIES&VIEW=DETAILV2&&ID=16767B8871AE73DD9F26C50ADC7470978A4BDC59&SELECTEDINDEX=31&CCID=FYZIDMCT&SIMID=607988596610895587&THID=OIP.M7F2CE20E671384F868D3FF1D674A498CO0
• RISK MANAGEMENT GUIDANCE
HTTP://WWW.FDA.GOV/DOWNLOADS/DRUGS/GUIDANCECOMPLIANCEREGULATORYINFORMATION/GUIDANCES/UCM073511.PDF
• PHONE DIMENSIONS PICTURE
HTTP://IMAGES.GIZMAG.COM/INLINE/IPHONE-5S-VS-5C-VS-4S-5.JPG
• PHONE TESTING PICTURE
HTTP://WWW.NTI-AUDIO.COM/PORTALS/0/PIC/EN/FX100-CONFIGURATION-MOBILE-PHONE-END-TEST.PNG
HTTP://I.YTIMG.COM/VI/BJ00250HRRS/MAXRESDEFAULT.JPG
• CHANGE CONTROL FORM PICTURE
HTTP://IMAGE.SLIDESHARECDN.COM/CHANGECONTROLFORM-121228013034-PHPAPP01/95/CHANGE-CONTROL-FORM-1-638.JPG?CB=1356679891
• BOOK
• HTTP://VECTORTOONS.COM/WP-CONTENT/UPLOADS/2015/05/PAPER-EMOJI-COLLECTION-326X575.JPG
• DESKTOP PICTURE
HTTPS://UPLOAD.WIKIMEDIA.ORG/WIKIPEDIA/COMMONS/THUMB/D/D7/EMOJI_U1F4BB.SVG/1024PX-EMOJI_U1F4BB.SVG.PNG
• BINDER PICTURE
• HTTPS://WWW.EMOJIBASE.COM/RESOURCES/IMG/EMOJIS/APPLE/X1F4D2.PNG.PAGESPEED.IC.NEUUWPRO2W.PNG
• QUESTION MARK PICTURE
HTTP://WWW.SAQUIRESEARCH.COM/WP-CONTENT/UPLOADS/2013/05/COLORFUL-QUESTION-MARK1.JPG
