9 regulatory compliance and validation for li
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9 regulatory compliance and validation for li
- 1. Valarie King-Bailey, M.B.A. Chief Executive Officer OnShore Technology Group
- 2. Life Sciences Industry Challenges What Is Validation? How Do You Sell It? How Much Does It Cost? What Is The Validation Toolkit? Validation Automation – What You Need To Know What Every Partner Should Know
- 4. In 2011 the Pharma industry will face negative growth $ 62BN of sales will be lost to Generics in the US by 2011 Pharmaceutical Only 1 in 20,000 compounds make it to market Costs of taking a drug to Market in US exceeds $1.4B As much as 80% of revenue comes from new products (< 2 yr old) New regulations appear regularly from both states and feds Medical Devices Most hospitals have WiFi, but they struggle with Device Mgmt Biotechnology Biosimilar legislation in US puts billions of revenue at risk
- 5. • Disparate Systems • Legacy Systems • Huge Amounts of Data/Records • High Cost of Downtime • Lack of Automation Between Machines / Systems • Internal “Production Focus” Metrics • Many Manual Touch Points • We Validate All GMP Functionality In AX
- 8. FDA Definition Of Validation demonstrating evidence documented consistently predetermined specifications quality attributes
- 9. Developers CANNOT Check Their Own Work Ensures Quality Ensures Objectivity
- 10. 1. IQ 6. GMP 2. OQ 7. GAMP 5 3. PQ 8. Predicate Rule 9. QA 10. Change Control 4. 5. Part 11 SOP
- 11. GAMP 5® is an international standard designed to harmonize validation requirement across the globe. It was written by a life sciences industry consortium. PARALLELS SURESTEP® METHODOLOGY
- 14. ERP Engagement Project Plan
- 15. Hosted (Data Center) On-Premise Virtual EACH OPTION HAS UNIQUE IMPACT ON VALIDATION
- 17. “…You have failed to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of the production or the quality system, as required by 21 CFR 820.70(i)…”
- 18. You have failed to document maintenance activities, including the date and individuals performing those activities, as required by 21 CFR 820.70(g)(1).
- 19. “…Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 C.F.R. § 820.70(i)… Specifically, your firm has not maintained documentation of the validation of the computer software…”
- 23. Think Validation FIRST! Ask About Outsourcing Versus In-House Validation Ask About Deployment Environment (Hosted/OnPremise) Complete Validation Questionnaire With Prospect Do NOT Quote Fixed Price (T&M Only) Bring Validation Team In As Early As Possible
- 24. Q: Within your organization, what functional group is ultimately responsible for selecting and prioritizing ERP software investments? Who Should Be In The Room? Plant Manager 0% HR/Personnel 0% 1% Marketing/Sales 6% Plant or Manufacturing IT 7% Finance/Accounting 18% Business Operations 27% Corporate IT 41% Senior Executive Management 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% AMR Research ©2012
- 25. You do not have a clear understanding of client requirements Client is uncomfortable with your knowledge of validation You fail to give them a comfort level with the services they will receive You are caught in a price bidding war You cannot answer their questions during the sales process
- 30. Minimize Cost Of Validation & Verification Rapid Deployment Of Dynamics AX/NAV Minimize Risk Across Project Ensure Compliance With cGMP Regulations & 21 CFR Part 11 Maintaining A Validated State Over Time
- 31. IT Director/VP Who Understands Validation SMB Pharma/Med Device/Biotech/CRO Customer With Approved Budget Knowledgable About Regulations Significant ERP/Compliance Pain
- 32. Ask to speak to QA regarding their validation process Mention the Validation Toolkit as a validation starting point AT THE BEGINNING OF THE SALES CYCLE! Ask Prospect does the system require validation upfront
- 34. High Range Medium Range Low Range • $100 - $200k • OTB Installation • $200 - $400k • Some Customizations • $400 – 600k+ • Significant Customizations • Integrated 3rd Party Applications
- 36. Don’t Understand Validation Requirements Dont Understand The Industry Sector Challenges Cant Speak the language of life sciences companies Don’t Involve The Validation Team Early Enough Don’t Adopt Validation Processes Into The Overall Implementation Project Validation is an AFTER THOUGHT
- 37. Listen! Get The Right People Learn The Language of Validation In The Room Establish Credibility Early Emphasize Value Sharpen the Saw: Commit To Life Long Be Flexible: One Size Learning & Does Not Fit All Improvement
- 44. Customizable Output in Microsoft Word Format
- 46. Insert New Steps To Your OQ Script With Ease
- 47. • Allows Real Time OQ Test Script Execution In The Actual Software Environment • Reports Failures During Execution • Excellent For Re-validation Exercises • Saves 60% of Testing Time PROCEDURE CAPTURE IS OPTIONAL AND IS AVAILABLE FROM ONSHORE TECHNOLOGY GROUP
- 51. No Understanding Of The Validation Process No Understanding Of Regulatory Requirements/Impact Over-Customization No Process Control During AX Configuration/ Development Failure To Establish Change Control Lack of Training
- 53. Think Validation FIRST! Understand Applicable Regulations Understand Deployment Options (hosted, on-premise) Don’t Over-customize Train! Train! Train! Sell Toolkit and Automation Testing Tools Understand Validation Service Options
- 54. THANK YOU!
Hinweis der Redaktion
- SmartArt custom animation effects: upward arrow process(Basic)To reproduce the SmartArt effects on this slide, do the following:On the Home tab, in the Slides group, click Layout, and then clickBlank. On the Insert tab, in the Illustrations group, click SmartArt. In the Choose a SmartArt Graphic dialog box, in the left pane, click Process. In the Process pane, click Upward Arrow (sixth row, third option from the left), and then click OK to insert the graphic into the slide.Select the graphic, and then click one of the arrows on the left border. In the Type your text here dialog box, enter text. (Note: To create a bulleted list below each heading, select the heading text box in the Type your text here dialog box, and then under SmartArtTools, on the Design tab, in the CreateGraphic group, click AddBullet. Enter text into the new bullet text box.)On the slide, select the graphic. Under SmartArtTools, on the Design tab, in the SmartArtStyles group, do the following:Click ChangeColors, and then under Colorful click Colorful Range - Accent Colors 3 to 4 (third option from the left).Click More, and then under Best Match for Document click Intense Effect (fifth option from the left).On the Home tab, in the Font group, select Calibri from the Font list, and then select 24 from the Font Size list.Select the text in the first text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickOliveGreen, Accent 3, Darker 25% (fifth row, seventh option from the left).Select the text in the second text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickAqua, Accent 5, Darker 25% (fifth row, ninth option from the left).Select the text in the third text box from the left. Under SmartArtTools, on the Format tab, in the WordArtStyles group, click the arrow next to TextFill, and then under Theme Colors clickPurple, Accent 4, Darker 25% (fifth row, eighth option from the left).To reproduce the animation effects on this slide, do the following:On the Animations tab, in the Animations group, click CustomAnimation.On the slide, select the graphic. In the CustomAnimation task pane, do the following:Click Add Effect, point to Entrance, and then click MoreEffects. In the Add Entrance Effect dialog box, under Basic, click Wipe. Under Modify: Wipe, in the Direction list, select From Left.Under Modify: Wipe, in the Speed list, select Fast.Also in the Custom Animation task pane, select the wipe effect. Click the arrow to the right of the wipe effect, and then click Effect Options. In the Wipe dialog box, on the SmartArt Animation tab, in the Group graphic list, select One by one.Also in the Custom Animation task pane, click the double arrow under the wipe effect to expand the contents of the list of effects.Also in the Custom Animation task pane, select the second wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects. In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select With Previous. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation taskpane, select the third wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select With Previous. Under Modify: Descend,in the Speed list, select Very Fast.Click the arrow to the right of the third wipe effect, and then click Timing. In the Descend dialog box, on the Timing tab, in the Delay box, enter 0.5.Also in the Custom Animation task pane, select the fourth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select On Click. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation taskpane, select the fifth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select After Previous. Under Modify: Descend,in the Speed list, select Very Fast.Also in the Custom Animation task pane, select the sixth wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Exciting, click Curve Up.Under Modify: Curve Up,in the Start list, select On Click. Under Modify: Curve Up,in the Speed list, select Very Fast.Also in the Custom Animation task pane, select the seventh wipe effect and then do the following:Click Change, point to Entrance, and then click More Effects.In the Change Entrance Effect dialog box, under Moderate, click Descend.Under Modify: Descend,in the Start list, select After Previous. Under Modify: Descend,in the Speed list, select Very Fast.To reproduce the background effects on this slide, do the following:Right-click the slide background area, and then click Format Background. In the Format Background dialog box, click Fill in the left pane, select Gradient fill in the Fill pane, and then do the following:In the Type list, select Linear.In the Direction list, click Linear Right (first row, fourth option from the left).Under Gradient stops, click Add or Remove until two stops appear in the drop-down list.Also under Gradient stops, customize the gradient stops that you added as follows:Select Stop 1 from the list, and then do the following:In the Stop position box, enter 39%.Click the button next to Color, and then under Theme Colors click White, Background 1 (first row, first option from the left).Select Stop 2 from the list, and then do the following: In the Stop position box, enter 100%.Click the button next to Color, and then under Theme Colors click Olive Green, Accent 3, Lighter 60%(third row, seventh option from the left).To increase the size of the SmartArt graphic so that it spans the entire slide, do the following:On the slide, select the graphic. Point to the top right corner of the graphic border, until a two-headed arrow appears. Drag the top right corner of the graphic border into the top right corner of the slide. Point to the bottom left corner of the graphic border, until a two-headed arrow appears. Drag the bottom left corner of the graphic border into the bottom left corner of the slide.