Regulated Documents. A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents

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1 Regulated Documents A concept solution for SharePoint that enables FDA 21CFR part 11 compliance when working with digital documents

2 Contents Life science industry challenges Regulated Documents our service offering Solution overview Software Components Introduction company OpenDocs Contact details 2

3 Life Science Industry Challenges Increased drug development time and cost Average time-to-market is 10 to 15 years Average cost is $1B Increased regulations and market requirements Increased competition requires process improvements 90% of corporate memory is on paper 15% - average time reading the right information 50% - average time spent searching for information 19 - average times a document gets copied 25% - average annual document growth 3

4 Regulated Documents by OpenDocs Tag cloud Requests to external systems Digital signatures Search Periodic review Unique document number Document templates Monitoring Reporting notifications Document metadata Document versions Intuitive task forms 21 CFR Part 11 Consistent Document Management Processes A centralized collaboration platform 4

5 Concept of service offering Regulated Documents service offering Regulated Documents Concept by OpenDocs Solution delivery Implementation support Fixed offer 5

6 Regulated documents Our service offering Fixed offer of the Regulated Documents solution Installation together with your IT team Avoid budget risks Use of trial licenses for all software components for a limited period Optionally: installation and configuration of SharePoint if not already there Implementation of the Regulated Documents solution through a joint implementation project based on GAMP Including user training (train the trainer) Including design, user and administration documentation Optional support contract (4 hour response window through remote access) 6

7 Typical procurement process RFI OpenDocs delivers product information OpenDocs provides online demonstration Quote 1 OpenDocs sends high level quote with Approach and high level project costs Software license costs URS User requirements are gathered and analysed Supported onsite by an OpenDocs consultant and access to Regulated Documents solution Quote 2 After having completed the URS, OpenDocs will quote the entire project Client decides to: start the project, buy the solution plus software licenses Project Project continues until solution is completely in use Assumption is that 80% of solution is already there 7

8 Project phasing UR analysis Access to our hosted Regulated Documents Onsite training Onsite requirements analysis Updated quote (quote 2) for entire project Design OpenDocs writes a functional design based on the user requirements specification. Deliverables: technical design (including interfaces and infrastructure), operation protocol, migration plan Realization Our Regulated Documents solution is adapted according to functional design Preparation of staging environment (SharePoint + K2 + cosign) User and administration documentation Formal acceptance of solution and documentation by client Pilot Preparation of production environment Test the new solution and ways of working using the Operational and Performance Protocol Only one department or subset of users Calculate for minor changes in solution and documentation Rollout Migration of existing documents to Regulated Documents Training Start using the Regulated Documents solution in the entire company Aftercare Handover to IT management Optional support contract with OpenDocs 4 hr response time Start with continuous improvement 8

9 Regulated Documents Dashboard Start a workflow Review your tasks 9

10 Regulated Documents Solution overview Document Processes Roles Components Author 2. Document manager 3. Reviewer(s) 4. Approver(s) 5. Final approver 6. Auditor 1. Portal 2. Document Libraries 3. Workflows 4. Forms 5. Search 6. Digital signing 7. Tasks 8. Notifications 9. Reports 10. Personal views Creation Change Periodic review Cancellation Review Approval 10

11 Document process 1 Create document Creation based upon controlled document templates The workflow automatically places metadata into the new document In the basic setup reviewing and approval is combined, but can be easily separated 11

12 Create document screenshots 12

13 Create new document - screenshot Forms based on InfoPath Optional: ASP.NET forms In both cases your IT team can modify the forms themselves if you have the proper tooling 13

14 Approve document Review simultanuously (e.g. 3 reviewers parallel) Multiple sequential or parallel approval rounds Connection to external system(s) notifications Digital signing (see next slide) 14

15 Digital signing Sign in SharePoint or directly in document (Word, Excel, PDF etc.) 15

16 Change document Author requests change to the Document Manager After change Approval required 16

17 Cancel document Author requests cancellation to Document Manager Author needs to agree with rejection Optional: involve approvers Cancelled document will be moved to archive 17

18 Task completion Complete your task in the browser User configurable task list 18

19 Using SharePoint document libraries Screenshot - all documents in draft version 19

20 Real-time process monitoring (example screenshot)

21 Monitoring & administration by Document Manager

22 Reporting & auditing Audit on document Workflow history Management overview Track user performance 22

23 Regulated Documents Technical overview Work with documents other Complete your task Task notifications and status updates Review documents SharePoint Server InfoPath Forms Services Exchange Server Regulated Documents Solution cosign K2 Server 23

24 Software Components of the Regulated Documents solution 1. Microsoft Office 2010/2013 Word, Excel, Powerpoint for editing Outlook for receiving workflow task notifications 2. SharePoint 2010 (2013 soon) Enterprise license if InfoPath required Standard license if forms based on ASP.NET or K2 SmartForms 3. InfoPath Basic solution uses forms based on InfoPath InfoPath comes with an Enterprise license and fits companies with a clear vision on how to optimize business processes throughout the company If required, forms can be delivered as ASP.NET forms including source code 4. K2 BlackPearl (http://www.k2.com) A Visual Workflow tool that enables you to easily model and execute processes according to your way of working (also see 21CFR Part11 statement here) 5. ARX cosign (www.arx.com) Tool for digitally signing documents integrated in Regulated Documents Can be used within Regulated Documents, but also adhoc for signing contracts, purchase orders and so on so the entire organisation can benefit from paperless signing documents. 24

25 Component justification Why Microsoft Office? Your users already use Word, Excel, Powerpoint and Outlook today. Why SharePoint? SharePoint rapidly becomes the default information platform and links easily with Microsoft Office and other third party products. Why InfoPath? Companies that have a clear vision on how to optimise their business processes will need to be able to easily create solutions with electronic smart forms and workflows; InfoPath reduces the need for developer hours and allows for faster delivery of new solutions within your company. Also see here. Why K2? SharePoint doesn t offer rich workflow functionality that allows for automation in a fast and graphical way. K2 allows for creating workflows without developers. Also see here. K2 fits in a regulated environment, see here. However, if your organisation has no need for further process automation, we can offer this concept based on SharePoint 2013 workflows as well. Why cosign? Lots of processes become automated, but when it comes to signing, most companies still print on paper. This slows down processes and is not completely traceable. cosign offers state-of-the-art digital signing solutions that can be used from within Microsoft Office. See here. 25

26 Beyond Regulated Documents Once working with forms, workflows, electronic documents and e- signing is introduced into your company, other processes can start to benefit as well from the components you own: Optimise other QA processes Corrective and Preventive Actions (CAPA - see here in Dutch) Customer Feedback process Optimise R&D processes Specifications Approval Conference insights Optimise HR processes Employee onboarding (see example) Employee self service portal Optimise financial processes Purchase-to-pay Investment Approval Requests 26

27 Technical Document creation workflow This is an actual workflow in K2 Workflow Designer; advantage of using K2 is that processes as delivered can easily be modified to your needs with a graphical interface 27

28 Regulated Documents more than tooling! Ensure proper project management Choose an approach based on GAMP so the solution can be validated Form the right project team You are in charge of the project Business in the driver seat Consultants can help you making informed decisions and realise solutions Do not leave project execution to software vendors Introducing a Regulated Documents solution means changing the way people work Proper training Stay focused on changing behaviour 28

29 Regulated Documents solution Solution summary Enforces workflow for document processes Document creation based on controlled templates Review & Approval Cancellation Document changes Periodic review Based on Microsoft SharePoint 2010 or 2013 Document versioning (minor / major) Expiration policies Offers digital signing (we use ARX cosign) Microsoft Office as document editor Access work through task lists Management reports Role based Processes can be easily modified to organisational needs Allows the organisation to be 21 CFR part 11 compliant Supports complying to 21 CFR Part

30 Summary Industry issues Time and costs of product development in a regulated environment increase Operational efficiency must be improved Still a lot of manual paper handling Regulated Documents Solution for SharePoint Automated creation and management of submission ready documents Integration with familiar editors fits Microsoft environment Ease of implementation Configured based on standard components No need for external consultants for future changes Note: when using ASP.Net Forms instead of InfoPath, adding new fields requires Visual Studio and probably does require external consultancy Adherence to regulatory requirements 30

31 OpenDocs Company overview Founded in 2001 Consultants of medior/senior level specialised in SharePoint, K2, Livelink and complementary products Services ranging from business consultancy to IT Support Enterprise Content Management Specialists 31

32 Customers 32

33 Thank you for your attention! This Regulated Document concept has been built for OpenDocs customers as separate projects; however, it s our ambition to serve more customers in regulated environments by delivering proven solutions that can be tailored to suit a specific way of working. Our concepts are based on products of market leaders and never contain OpenDocs proprietary code or products. Feel free to contact us for a demonstration. OpenDocs bv Het Wielsem BW s-hertogenbosch The Netherlands +31 (0)

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