2021 whitepaper

Whitepaper

https://www.scilife.io/

Whitepaper Contents page 2 of 49

01Our Story

02Why ScilifeSet up & go

Customizable

Ensures inspection-readiness

Easy for Everyone

Prevalidated according to GAMP5 and 21 CFR part 11

06Onboarding & SupportOnboarding process

Upgrades & Bug fixes

Service desk & Knowledge base

07Cost StructurePay per user

Storage costs

One-time setup fee

08Our Customers

03ModulesAll Modules

According to industry:- Pharma & Biotech- Medical Devices

04Key FeaturesConfigurable workflows

Automatic notifications

Seamless module and app integrations

Electronic signatures

Custom user roles

05Tech SpecsSoftware environments

User interface- Dashboard- List Pages- Form Pages- Detail Pages

Cloud security

Contents

This document is interactive, you can navigate through the

contents by clicking on titles


01Our Story

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01 Our Story

Our story began a few years ago, when we launched our software-as-a-service (SaaS) company QbD Software with our leading Life Science consultancy partners QbD.

We started off building several custom projects, including a cloud-based quality management (QMS) solution we called QualityKick. QualityKick took off to such an extent that we decided to focus all our energy on it, and expand it into something much bigger and far-reaching than a QMS.

We wanted to create an all-in-one digital platform that met all quality, process, and product needs our customers might have during every one of their industry lifecycle stages. We also wanted to tailor our solution exclusively to Life Sciences companies. It soon became clear that we needed a new name and rebranding to match our evolution.

Scilife was born!



01 Our Story

Now, we’re proud to offer you a first-class, highly specialized Life Sciences accelerating platform. We help Pharma & Biotech, Medical Device, and ATMP companies like yours ace audits, improve processes (quality and non-quality related), and save valuable resources in their journey towards competitivity.

Our Scilife platform is fully digital and cloud-based, meets the stringent regulatory requirements of the industry, is totally customizable, and grows as you grow. Plus, our stellar customer support team is by your side to guide you every step of the way.



We’re here to be your true Life Science allies; helping you go paperless, get lean, reduce costs, and drastically improve the entire lifecycle of your product and process workflows.

Save time to invest into life-changing research.

02Why Scilife

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02 Why Scilife

Set up & goScilife is entirely cloud-based. It requires no hardware installation, physical storage space, or in-house maintenance. Your data is secure and backed up at all times by AWS cloud technology. Scilife also comes with out-of-the-box functionality that serves 80% of the Life Sciences industry needs. It’s a one-size-fits-all solution for Life Sciences companies of any size.

CustomizableIf a standard system isn’t what you’re after, Scilife lets you configure all workflows and forms to meet your unique needs.



02 Why Scilife

Ensures inspection-readinessIn such a highly regulated environment, it’s vital to be ready for audits at all times. Risk assessment is infused into our platform, so you can rest assured knowing you’ll have a spotless audit trail at any time. From risk-proof design, to effective implementation of CAPAs, to compliant e-signatures and approval workflows, to painless assignment and follow-up of compliance trainings. Everything is transparent and traceable, all the time.

Easy for everyoneOur Scilife user-friendly interface is simple, intuitive, and browser-based. This makes the Scilife platform accessible from anywhere, by anyone, and really easy to learn.



02 Why Scilife

Prevalidated according to GAMP5 and 21 CFR part 11Scilife comes prevalidated according to GAMP5 and 21 CFR part 11. In 2020, Scilife earned the ISO 9001:2015 certification with zero findings. We perform 95% of validation activity so that you don’t have to repeat the same work on your end unnecessarily, a big resource saver. Scilife software is frequently updated, so you can keep up with the most up-to-date regulations.


03Modules

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03 Modules

Create your own Scilife platform by picking and choosing the right modules to fit your needs. All modules link together to create seamless and efficient workflows.

Document ControlOur Scilife Document Control module standardizes and sorts your documents, effortlessly. Automated input variables and integrations to your existing document editing apps, like MS Office, speed up document creation. Detailed action logs and save histories leave a spotless audit trail. Automatic notifications are sent to specific users that need to take action, and documents are signed off electronically, streamlining approval cascades. Custom user permissions and controlled printing safeguard sensitive paperwork.

Read more about Scilife Document Control module


https://www.scilife.io/document-control-module


03 Modules

Print & ReconciliationStay FDA 21 CFR 11 compliant through efficiently controlled printing and reconciliation. Our Print & Reconciliation module logs every print action and tags every printed page with a unique barcode for easy identification and retrieval. Our module integrates to your existing apps, so you can issue a printout from anywhere. Printed paperwork can also be grouped, giving you a handy overview of the reconciliation status of any document package at a glance.

Read more about Scilife Print & Reconciliation module

TrainingsKeep everyone in the company fully compliant with ease. Our Trainings module makes creating, and keeping track of employee trainings a breeze, through highly customizable templates. Create individual trainings based on job positions, or set up group trainings. The right employees will be notified automatically. Configure your ideal training matrix by arranging automatic retraining and training assessments. Supervisors and employees can follow training progress on the Training Detail page, and trainings are signed off with compliant electronic signatures.

Read more about Scilife Trainings module


https://www.scilife.io/print-and-reconciliation-module

https://www.scilife.io/trainings-module


03 Modules

CompetencesUnearth valuable talent in your team. Stay up to date on the evolving skills of each of your employees through our detailed competences matrix and CV management tool built into our Competences module. Allow employees to define their own competences and skill levels, or assign this to supervisors. Export or print any CV in standardized formats. Our Competences module can also connect to our Trainings module, which allows competences to be updated automatically as trainings are completed.Read more about Scilife Competences module

Quality Process DesignerFor designing very specific and detailed workflows, especially at enterprise level, our Quality Process Designer module is the right choice. This module integrates smoothly with the other Scilife modules, so that syncing up data and workflows is effortless. Create your own unique workflow from scratch or duplicate one of our standard workflows and modify it to be exactly what you want. No programming skills required!

Read more about Scilife Quality Process Designer module


https://www.scilife.io/competences-module

https://www.scilife.io/quality-management-module


03 Modules

EventsCapture and follow up every issue in our Events module. Register deviations, nonconformities, and complaints in a few clicks. Set up limitless event types, add custom fields, and preconfigure the details. Trace back responsibility through tags, and upload proof where needed. Event creation, investigation, and review phases are in a seamless cascade to make the whole event workflow smoother and reach closure quicker. CAPAs can be linked since Scilife modules are all connected.Read more about Scilife Events module

CAPAsEveryone can stay on top of Corrective and Preventive Actions (CAPAs) effectively in our CAPAs module. Map out a CAPA action plan with our intuitive template, set up automated notifications to reach your assigned approvers, program follow-up notifications, and fast-track CAPAs to closure. CAPAs are linked to our Events, Audit and Change Control modules, enabling sophisticated workflows.

Read more about Scilife CAPAs module


https://www.scilife.io/events-module

https://www.scilife.io/capas-module


03 Modules

Change ControlOur Change Control module lets you create a clear path for the request, approval, and implementation of modifications, empowering your whole company to participate in changes. Incorporate risk & impact assessment, cost estimate, and a defined task pipeline with automatic notifications to those involved as well as the possibility to upload proof and electronically sign off. Change requests can be triggered by linked CAPAs from the CAPA module. Change Control is also linked to Document Control, in case document updates are needed.Read more about Scilife Change Control module

AuditsOur Audits module handles all types of audits; including supplier, internal, outgoing, and incoming audits. Whether you’re hosting or performing an audit, our Audit module makes it effortless. It integrates seamlessly with our other modules like Events, CAPAs, and Change Control so all required information is linked and easily accessible to export to regulatory bodies in a few clicks.

Read more about Scilife Audits module


https://www.scilife.io/change-control-module

https://www.scilife.io/audits-module


03 Modules

Risk AssessmentCreate and manage the full risk assessment process within our Risk Assessment module. Link risk assessment to deviations, nonconformities, CAPAs, and audits to keep everything in one place since all modules are seamlessly integrated. Automate risk scores or set up manual scoring. Program periodic reviews while maintaining version control over all previous versions. Tailor your risk assessment workflows exactly as you want them.Read more about Scilife Risk Assessment module

EquipmentEquipment maintenance and calibration requires careful planning, management, and proof to ensure continued safety and inspection readiness. Set up simple, effective workflows in our Equipment module by configuring equipment types, enabling automatic notifications and setting maintenance due dates. Nonconformities or deviations created in our Events module can be easily linked to an Equipment element as all modules are connected.

Read more about Scilife Equipment module


https://www.scilife.io/risk-assessments-module

https://www.scilife.io/equipment-module


03 Modules

Quality by DesignIf you’re using Quality by Design methodology, our purpose-built QbD module is ideal. Simplify the path to improving complex processes in your company by having all process-related data and process-improvement iterations in one central location.Read more about Scilife Quality by Design module

Design & Development (release planned Q2 2022)

Our new module lets you manage the whole medical device design & development process from user needs to design verification and validation according to ISO 13485. Our Design and Development module lets you link elements, maintain version control, use fully compliant approval e-signatures and streamline risk assessment in a single effective workflow. It really speeds up getting your medical device to market by ticking all compliancy boxes and keeping everything centralized.Our Design & Development module will be released in 2022!

Read more about it here.


https://www.scilife.io/quality-by-design-module

https://www.scilife.io/design-and-development-module


03 Modules

KPIOur KPI module provides you with the real-time performance metrics and historic trends you need to know in order to oversee how your company is doing and find actionable areas. With our intuitive dashboard, visualize a wide range of key metrics in interactive graphs and tables. Click on any data to drill down and see stats on a quarterly, monthly, weekly, and daily basis and use filters for detailed analyses. If needed, export Scilife data in a few clicks to easily import it into your existing business intelligence tools.Read more about Scilife KPI module

Validations (release planned end 2022)

Our Validations module makes managing validation projects a breeze. It automates the linking of items, maximizing efficiency and traceability. Design custom document templates within the module to lay out responsibilities, and the exact order of approval (with digital sign-offs). Our module lets you define and export everything required by regulations.Our Scilife Validation module will be released at the end of 2022! Read more about it here.


https://www.scilife.io/kpi-module

https://www.scilife.io/validations-module


03 According to Industry

Pharma & BiotechChoosing our Events module in combination with our CAPAs and Change Control modules provides out-of-the-box functionality and meets GMP regulations; sufficient for most Pharma and Biotech SMBs. For larger companies and enterprises, our purpose-built and highly configurable Quality Process Designer module is a better replacement for these 3 standard modules.

Read more about Scilife for Pharma & Biotech


https://www.scilife.io/pharma-biotech


03 According to Industry

Medical DevicesFor Medical device companies, a validated QMS is a core requirement according to ISO 13485. Our standard quality management modules (Events, CAPAs and Change Control) are sufficient to efficiently manage Medical Device quality processes.

However, our Document Control module is not really built to support the design process of medical devices. Intead, our Design & Development module in combination with the other modules are ideal for Medical Device companies to manage all their design and quality related processes in one single platform.

Read more about Scilife for Medical Devices


https://www.scilife.io/medical-devices

04Key Features

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04 Key Features

Configurable workflowsScilife comes with efficient ready-to-use workflows in all modules, that fit most use cases. If your processes need more fine-tuned cascades, every workflow is customizable, so you can tinker and design the perfect workflows for your needs.

Electronic signaturesGone are the days that documents need to be printed, hand-signed and scanned back into the system to achieve compliance! Scilife lets each of your users implement a unique electronic signature that’s fully compliant according to 21CFR Part 11. It speeds up workflows, and leaves a spotless audit trail.



04 Key Features

Automatic notificationsScilife takes care of notifying the right people at the right time for when their action is required for a specific task. Users can decide whether to receive emails or be notified directly in their Scilife dashboard. There’s no need to remember who needs to follow up when, and if users don’t act, automatic reminders are sent to urge participation. Users can leave comments throughout the platform, and there’s an integrated chat function too.



04 Key Features

Seamless module and app integrationsAll Scilife modules connect together seamlessly, for maximum workflow efficiency and traceability. Linked items are clickable, so all important details are accessible instantly. What’s more, Scilife modules integrate with your existing applications to pull everything together into an all-in-one solution.



04 Key Features

Custom user rolesCustom user roles are used throughout the Scilife platform to safeguard sensitive data and protect workflow and system integrity. You choose who can do what. The four types of custom user roles available are:

Read-only user

Depending on where you grant these users access, users with read-only rights can’t create elements or participate in approval workflows. They can sign off on trainings, and only view the documents you provide access to. Useful for suppliers and other external parties.

Regular user

The user role given to most of your company, a regular user can create new items, take part in workflows, sign off on trainings, and view the documents and items you grant access to.

Managers

Managers can be given greater access rights, such as being able to view more event types and monitor team performances. You’re in charge of how much configuration they can do within the platform.

Administrator

Admin access to all features of Scilife.


05Tech Specs

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05 Environments

TestingUse this environment to try out new functionalities before they are implemented.

ValidationThe ideal environment for testing and training before going live in production, and also where the final validation steps can be taken.

ProductionThis is the live environment where your actual production data is stored.



05 User Interface

User-Friendly Layout Scilife is a flexible and modular platform. Modules are only activated and functional if you need them. The modules you see in your Scilife are the ones you’ve signed up for. The structure of these modules is straightforward to understand, as there are only four screens that explain their full functionality. Once you understand one of Scilife’s modules, you can easily find your way around other modules as well.



05 User Interface

DashboardShows a user’s personal ‘to-do list’ of activities. This can include things like sign-off actions that are still pending (on CAPAs, Events, Documents, etc) and training tasks that need completing.



05 User Interface

List PagesElements in each module are shown in list pages, with filters in the top right and action buttons in the top left corners. All lists throughout the platform are exportable in CSV and Excel format.



05 User Interface

Form PagesForm pages, used to create or edit elements, are extremely user-friendly as they all are alike. Form fields are self-explanatory and are provided with help text in case a user needs further explanation to enter the correct details.



05 User Interface

Detail PagesThese appear when you click on any ID or element title. Again, detail pages are all alike and provide you with the information you need in a user-friendly way. They highlight linked elements easily, so navigating between detail pages is achievable in a few clicks.

Standard Operating Procedure Title: ${Document_title}

Document n°: ${DocumentId} Revision: ${Version}

Date of effectiveness: ${Published_date}

Scilife NV - Confidential document Page 1 of 4

Name Function Digitally Signed

Author Jane Doe QA Assistant May 20, 2021 06:40:24 (UTC/GMT +02 00 - Europe/Brussels)

Reviewer John Smith QA Assistant May 21, 2021 04:50:37 (UTC/GMT +02 00 - Europe/Brussels)

Approver Phil Anthony QA Manager May 21, 2021 06:53:21 (UTC/GMT +02 00 - Europe/Brussels)

QA Astrid James CSM May 22, 2021 08:40:24 (UTC/GMT +02 00 - Europe/Brussels)

1 Contents 1 Contents ..................................................................................................................................................................................................... 1 2 Overview .................................................................................................................................................................................................... 2 3 Purpose ....................................................................................................................................................................................................... 3 4 Scope ........................................................................................................................................................................................................... 3 5 Responsibilities ..................................................................................................................................................................................... 3 6 Procedure .................................................................................................................................................................................................. 3 7 Related documents ............................................................................................................................................................................ 3 8 Definitions ................................................................................................................................................................................................. 3 9 Version History ...................................................................................................................................................................................... 4



05 Cloud Security

Hosted on Secure and Compliant Cloud InfrastructureWe use Amazon Web Services (AWS) as our secure cloud service provider. AWS is still the best on the market, as per Gartner, holding this prized top spot for over a decade. Since we operate in a tightly regulated space, compliance is of prime importance. AWS meets all the essential compliance standards required in the Life Sciences industry (read more on their website)


https://aws.amazon.com/compliance/programs/

https://aws.amazon.com/compliance/programs/


05 Cloud Security

Disaster-proof Backup TechnologyWe use the Amazon S3 service for storing documents. This service replicates a file in three separate global locations as soon as it is uploaded, ensuring a robust data backup strategy.

Scilife is run on virtual application servers in the cloud, allowing it to scale out and scale down automatically depending on the usage demand at any particular moment. This saves costs on infrastructure, which translates into a highly cost-effective solution for you. It also protects against server failure, as new servers are activated automatically in minutes if hardware failures are detected.

To safeguard database data, a snapshot is taken every 5 minutes as a data backup policy. The backup is kept for 30 days.


06Onboarding & Support

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06 Onboarding process

Your Scilife Onboarding JourneyWe have a very systematic approach to onboarding new clients. We hold weekly meetings on the progress of the project to completion. The goal is to get you trained, validated, and to go live with your data in production in the least amount of time.

Núria describes every step of your Scilife onboarding journey, including how we help you migrate your existing data

Initial Onboarding meetingThe objective of this meeting is to explain the onboarding process. The relevant activities are discussed, and action items are agreed upon.

1

TrainingThe training of each Scilife module is recorded and shared to easily train future employees in your company.

2


https://www.youtube.com/watch?v=GY8rGTu6uq8



ValidationWe provide a validation package for each module. It contains a full validation according to GAMP5, drafted and executed on our end. This serves as a pre-validation on your end which you can leverage to do the last validation steps.

This effectively takes away ≈95% of the validation effort on your end.

IntegrationsIntegrations like MS Active

Directory or AzureAD are not a problem at all. Besides that,

Scilife is API-driven. Its RESTful API makes it very easy to

integrate with other systems.

3

4

OWASP




Data importOur team will guide you in analysing your quality system and to make the right choices. Once everything is clear, you will provide us with the data accordingly and we will take care of the import for you. After the data import has finished, we will ask you to verify and confirm that the data has been imported correctly.

3

4Weekly follow up meetings

A weekly follow-up meeting of 30 minutes

will be scheduled to ensure a successful

Scilife onboarding.



06 Upgrades & Bug fixes

Frequent module upgradesWe’re constantly upgrading our modules to meet the evolving needs of our Life Science customers. These upgrades occur 1-3 times a year per module. With each upgrade we provide an updated validation package, which includes a change list containing information on the improvements that have been made. The updated validation documentation package is provided 60 days before each new version release. During this time, you’ll already have access to the new version in your Validation environment. All our customers have a 60 day time window to review, perform selected tests, and sign off on validation documentation on their end. Depending on the nature of change, a medium or major version increase is assigned to the upgraded module.



06 Upgrades & Bug fixes

Rapid bug fixesBug fixes are made as soon as possible. Differing from planned upgrades, they’re carried out with a shorter Change Control process (known as ‘Low Impact Change Control’ or LICC) in which we describe the problem along with its solution, perform and describe the tests, and send out a signed Change Control document to all relevant customers. This type of upgrade only causes a minor version increase in the module.



06 Service Desk & Knowledge Base

Scilife Knowledge BaseScilife boasts a rich Knowledge Base, where you can find detailed answers to frequently asked questions about the Scilife platform, modules, and features. It’s available on our website and searchable in the Scilife platform itself by clicking on the help button in the bottom right.



06 Service Desk & Knowledge Base

Support a click awayIf you can’t find what you’re looking for in our Knowledge Base, creating a support ticket is easy. As well as reporting issues or asking questions, you can create a ticket to make feature requests. Tickets are handled according to urgency by our Customer Success team. You can keep track of the status of your ticket via email or by logging in to our support portal.

Our Customer Success Manager Trine explains how we listen to and support you at Scilife


https://www.youtube.com/watch?v=LmgKA5euE5A

07Cost Structure

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07 Cost Structure

Pay for what you needThe cost structure of Scilife is flexible, transparent, and scalable. You only pay for what you need. Onboarding, upgrades, infrastructure, and full support are all included in the price.

Our pricing model is broken down into three parts:

Pay per user

We calculate your User Licence Cost depending on:· Number of users· User role assigned to each user· Number of modules each user has access to

Storage cost

Different organizations have different data storage needs. To ensure fair and reasonable charges, we calculate storage cost based on GigaBytes of storage used per month.

One-time setup fee

There is a one-time, fixed implementation cost which we calculate based on:· Setup and configuration requirements· Number of modules for which training is necessary· Data import services (if required)· Integrations with external systems (if required)


08Our Customers

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07 Our Customers

International and multi-modal Freight Forwarding and Logistics

Yusen Logistics use Scilife instead of their paper-heavy QMS to improve customer happiness

Medical Food

Pendulum use Scilife to supercharge operational efficiency

Medical Devices

Olfactomics use Scilife to streamline ISO 13485 quality processes

Read stories from our worldwide customers to learn how we help them boost the Life Science Industry.

Take me back to the contents page08. Our Customers page 47 of 30


https://www.scilife.io/customer-stories/yusen

https://www.scilife.io/customer-stories/pendulum

https://www.scilife.io/customer-stories/olfactomics

08. Our Customers Take me back to the contents pageWhitepaper page 48 of 49

Medical Devices

Confinis use Scilife to drastically reduce costs and time expenditure

Pharma, Biotech, and Healthcare

Novitan use Scilife to push their quality efficiency into hyperdrive

07 Our Customers

Take me back to the contents page08. Our Customers page 48 of 30

Healthcare

Hebias use Scilife to reduce risk and ensure audit success


https://www.scilife.io/customer-stories/confinis

https://www.scilife.io/customer-stories/novitan

https://www.scilife.io/customer-stories/hebias

Want to Know More?We’re here to answer all your questions

Let’s chat

https://www.scilife.io/get-in-touch