Informatizzare il laboratorio QC: un aiuto nella scelta NL42 Consulting 1

Transcription

1 Informatizzare il laboratorio QC: un aiuto nella scelta 2018 NL42 Consulting 1

2 Get to know the Team Isabel Muñoz-Willery Ph.D. Madrid, Spain Ph.D. in Biochemistry and Molecular Biology at Spanish National Research Council (CSIC) in Madrid Master in Molecular Biology at Pierre et Marie Curie University in Paris. 20 years experience in multinational companies serving life science laboratories in regulated market. EMEA Leader of Application Specialists teams experts Roberto Castelnovo Milano, Italy University degree in Computer Science from Milan University 30 years experience in the Laboratory Informatics market European Leader of Sales and Services organization in the Lab Informatics Business Co-Founders and owners of NL42 Industry domain experts, independent advisors operating from Europe with consultancy practices throughout the globe. Our mother tongues are French, Spanish and Italian Owners and organizers of the Annual European Congress, Paperless Lab Academy NL42 Consulting 2

3 Some history of paperless 1985 Laboratory Information Management System 32-bit system Approx. 2/4MB RAM, 100MB Hard Disk Boards 80x80 cm, RS-232 connectivity Streaming tape backup Paperless projects implemented Connecting lab instrumentation Communication with production Automatic printing of CoA Technology is not the Barrier 2018 NL42 Consulting 3

4 Why Going Paperless Reduce Time for manual transcription and related errors Ease the Access to Data Simplify the Review and Analysis Allow grouping of data into Informative Reports Ensure full Product Life Cycle data recording and traceability Ensure Integrity of the data Improve the efficiency in the acquisition, management & archiving of your data 2018 NL42 Consulting 4

5 How to go Paperless PEOPLE SYSTEMS PROCESSES 2018 NL42 Consulting 5

6 #People - Challenge the status quo Strong relationship between people and paper One production batch may generate up to 1000 data transcriptions on 15 different documents 70% of personal knowledge is typically lost when a person leaves the company Risk of damages, Forget technology Cost of paper: 20$ per document to classify, 125$ for each wrongly classified document, 600$ cost of a lost document Get the right team in place 2018 NL42 Consulting 6

7 #Processes Gain Effectiveness Get the End in Mind Who does what Quantify your Effectiveness Design the Future Build on your people Define your team mission and objectives Understand today s processes Get your team involved from the beginning Assumptions are made too often and quickly Real facts help to see the full picture New Processes are an opportunity to revisit your KPIs New Methodologies and Technologies support the Change Change Management is key for the success Trust, Training 2018 NL42 Consulting 7

8 #Systems An IT Strategy to support your Business Get the End in Mind Long term planning for complete harmonization and integration of your systems Prioritize There are always criticalities to get solved first Break down the elephant Know your limits $$ Build on your people Maximum of 6 months for a key milestone with clear ROI A quick cheap solution is never the long term economical best option. Understand the impacts of each potential solution An IT strategy is a constructive and positive corporate message to the team 2018 NL42 Consulting 8

9 Technology How to select a system? Avoid taking decision on one shot demo Construct fact-based evaluations Compare apples with apples Don t remove emotions The purchasing process is easily driven by emotions 2018 NL42 Consulting 9

10 Technology An accurate selection Process 1 Define your needs User Requirements Request for Information at international level Qualify the Answers Get to See it Choose YOUR solution Qualification of the answers (objective point rating) Presentation to technical committee Request for Proposal to best 3 options Demo agenda coordination Demo Script provided to candidates for proof of concept exercise Evaluation forms for the audience Qualification vs Technical, Company & Budget SWOT analysis Final Proposal 2018 NL42 Consulting 10

11 Technology An accurate selection Process 1 Define your needs Scope and User Requirements 2 Start the process when you know what you need Create a team to support the process : IT, purchasing, business Assign a project coordinator role to handle the communication with vendors Benefits of external help : Save time Gain knowledge Take advantage of their expertise You may need a puzzle of systems 2018 NL42 Consulting 11

12 Technology An accurate selection Process 1 Define your needs User Requirements Request for Information at international level 2 Make sure you are not driven by Google searches Avoid Acronyms: LIMS, ELN, LES, SDMS I need a LIMS should be converted into I need a system that does. or I need a system which is able to help me in Do not arrange meetings with the vendors yet 2018 NL42 Consulting 12

13 Technology An accurate selection Process 1 Define your needs User Requirements Request for Information at international level Category Benefits System requirements Corporate requirements Regulatory Workflow Why? Clearly state which are the expected advantages by implementing the system Define the size of the system, architecture, integration with other systems Define which IT or business requirements should be satisfied to be accepted within the company Define which functionalities are necessary to support the current regulations (different than indicating which regulatory references should be satisfied). Each company may have different expectations Define how the information should be processed, how the data should flow within the system, which controls should be introduced 2018 NL42 Consulting 13

14 Technology An accurate selection Process 1 Define your needs User Requirements Request for Information at international level Category Company background Product information Support information Quality system Service model Cost information Some product details Why? Collect information about the company in terms of: size, local presence, legal, resources available for the project, experience in selling the product, references Number of years in the market, GxP compliance, frequency of updates How is support provided, validation support, training offerings Presence of a quality system, quality manager Typical approach to the project implementation, example of project plan Preliminary information about licence, services and support costs Request information about the main features that should be present in the system, as a consequence of the User Requirements 2018 NL42 Consulting 14

15 Technology An accurate selection Process 2 2 Qualify the Answers Qualification of the answers (objective point rating) Presentation to technical committee Request for Proposal to best 3 options Qualify the answers and score the responses Use a numeric scoring system to evaluate the responses Focus on the product capabilities Evaluate the company reliability Assess your potential B2B relationship Ask for commercial information Do not decide based on the costs There is still time to negotiate!! 2018 NL42 Consulting 15

16 Technology An accurate selection Process 2 2 Qualify the Answers Qualification of the answers (objective point rating) Presentation to technical committee Request for Proposal to best 3 options Category Use numeric scoring Focus on product capabilities Commercial information Team review Move 3 companies Why? Remove the emotions and assess the responses to the RFI based on the real needs and the ability of the company to support your business At this point in time the goal is to identify the products that are potentially able to provide the required functionalities To have a first assessment of the cost impact Review the scoring as a team in order to collect all inputs (IT, business, purchasing, etc.) It is a fair number to perform a detailed assessment It does not require a large amount of time for the next phases It is sometimes required to have three commercial proposals 2018 NL42 Consulting 16

17 Technology An accurate selection Process 2 2 Qualify the Answers Qualification of the answers (objective point rating) Presentation to technical committee Request for Proposal to best 3 options Category Company background General conditions Process timelines RFP response outline Cost summary List of requirements Why? Present your company, your business and the goal of the project Clearly state how you are going to handle the RFP process, in terms of: communication, validity of the offer, etc. (purchasing department typically provides this type of information) Provide timelines for the process (when you need to receive the answers, date of the technical presentations, when you are planning to take the decision, expected timeframe for the contract signature and project delivery) Clearly define how you expect to receive the answer to avoid difficult comparisons Clearly state how you want to receive the commercial information Provide a list of requirements that you expect to cover (references to URS and RFI when needed) 2018 NL42 Consulting 17

18 Technology An accurate selection Process 2 3 Get to See it Demo agenda coordination Demo Script provided to candidates for proof of concept exercise Evaluation forms for the audience Drive the demos instead of being driven Technical sales people are experts in generating emotions Technical sales people are well trained in running technical presentations and focus on the strengths of their products 2018 NL42 Consulting 18

19 Technology An accurate selection Process 2 3 Get to See it Demo agenda coordination Demo Script provided to candidates for proof of concept exercise Evaluation forms for the audience Category Demo agenda Demo script Evaluation forms Technical assessment Why? To make sure the vendors are having the same opportunity (same amount of time, same presentation flow, etc.) It drives the technical presentation requesting the vendors to demonstrate that the product is able to cover a certain requirement To avoid the typical situation of: Is your system able to provide this functionality? and the answer is. YES Provide guidance to the attendees on how to score the system in terms of coverage, user interface, ease of use, etc. A scoring system to have full visibility on how the attendees have evaluated the presentations 2018 NL42 Consulting 19

20 Technology An accurate selection Process 2 4 Choose YOUR solution Qualification vs Technical, Company & Budget SWOT analysis Final Proposal Qualify the responses to the Request For Proposal Ask for clarification Focus on the commercial responses Licence vs subscription Maintenance Validation Focus on the proposed implementation plan Focus on the long-term ability to support your business Focus on the quality of the responses Move one company to negotiation Keep the others on hold 2018 NL42 Consulting 20

21 Technology An accurate selection Process 2 4 Choose YOUR solution Qualification vs Technical, Company & Budget SWOT analysis Final Proposal Category Technical evaluation Commercial evaluation SWOT analysis Negotiation Why? Have a fair assessment on how the product can be introduced in the company without major difficulties (integration, user interface, ease of use, coverage of requirements, etc.) Prepare a 5 years cost assessment based on the response to the RFP Overall summary on how the three options are responding to the business needs Move one company to the contractual negotiation, utilizing the responses to RFI and RFP To be completed in about 4 months 2018 NL42 Consulting 21

22 Summary of possible solutions Option 1 Option 2 Option 3 Infrastructure Client / Server Web enabled SaaS User interface Company strategy Completeness of the portfolio Static (typical Windows screens) Partially focused on the product (i.e. large companies including the product in their portfolio) Company focused on one (or few products) Configurable (IT needs to work in order to adapt) Re-seller (the company is selling several IT products, including the interested one) Company selling a partial set of products to satisfy the requirements Completely user-configurable Dedicated companies to the specific product Company selling a complete portfolio 08/10/ NL42 Consulting 22

23 Summary of possible solutions Compliance Cost of ownership Service model Local presence Option 1 Option 2 Option 3 Company focused on other market segments Licencing model plus maintenance Project implementation only with internal resources Large local presence (technical, project management, commercial, etc.) Company just entered in the market Subscription model Technical activities (i.e. training, configuration) performed with internal resources, other activities in collaboration with partners Typically limited local presence with offshore resources to adapt the system to the requirements Long-term presence in the market Completely outsourced Interested only in product revenues 08/10/ NL42 Consulting 23

24 A Paperless Plan As is Analysis Review the actual processes and the corresponding systems Identify the needs at technical, user and business levels IT Strategy & Business Case IT strategy at short, medium and long term Construction of a business case for senior management Process Reengineering Selection Process Review and design of new processes in line with the future system/s Update or creation of new SOPs Elaboration of URS, RFI, RFP, technical demonstrations SWOT analysis of best 3 fit to purpose Implementation & Validation Unique point of contact during the implementation Quality Expertize 2018 NL42 Consulting 24

25 Paperless Lab 2018 NL42 Consulting 25

26 Contacts Roberto Castelnovo NL42_roberto NL42 Consulting 26