Solidsoft Reply Ltd

Falsified Medicines Directive - VeriLite Verification and Decommissioning Tool

VeriLite allows pharmacists, GPs and other persons authorised or entitled to supply medicinal product to the public, together with wholesalers, to verify and decommission the unique identifiers printed on each pack of prescription medicine, allowing them to comply fully and simply with their legal obligations.

Features

  • Verification of medicine pack unique identifiers to meet FMD requirements
  • Decommissioning of unique identifiers to meet FMD requirements
  • Single- and Multiple (list) data entry modes
  • Safe mode to reduce risk of 'false positive' alerts
  • Reports and logs on all activities
  • Data import and export
  • Support for multiple locations
  • Advanced barcode scanner handling minimises risk of 'false positive' alerts
  • Off-line support with automated recovery features.
  • Local administration and user management features

Benefits

  • Supports full compliance with legal requirements of FMD
  • Strong focus on safe scanning to minimise 'false positive' alerts
  • Adapts dynamically to different roles (pharmacy, wholesaler)
  • Supports national systems in all EMVS markets (except Germany)
  • Brower-based cloud application with no software install or setup
  • Per user / per month subscription model with discounts
  • Minimises disruption when EMVS National System is unavailable
  • Full validation supported under GAMP 5
  • Provides independent evidence of compliance with legal requirements
  • Help desk support

Pricing

£25 to £45 a user a month

Service documents

Framework

G-Cloud 12

Service ID

8 2 4 8 8 7 7 3 6 9 7 7 0 3 5

Contact

Solidsoft Reply Ltd

Mark Usher

+44 1256 375700

m.usher@reply.eu

Service scope

Software add-on or extension
No
Cloud deployment model
Public cloud
Service constraints
VeriLite manages connections to EMVS National Systems including the SecurMed system in the UK. UK users must register with SecurMed separately to obtain the necessary certificates to access the National System.
System requirements
  • Browser-based - supports all major modern browsers and IE11.
  • No plug-ins or additional software.
  • Works with most barcode scanners. Users must supply scanner.
  • Connects on behalf of registered users to EMVS National System.
  • Depends on EMVS National System to perform verification and decommissioning.
  • Users must purchase subscription licences to access VeriLite.

User support

Email or online ticketing support
Email or online ticketing
Support response times
The response times are within 1 business hour. Service Desk (Core Hours) 9am – 5pm 5 days per week Monday to Friday (excluding English Public Holidays). Extended hours (e.g., 7am to 7pm) and Saturday cover can be provided. Response times outside of these hours is next business day.
User can manage status and priority of support tickets
Yes
Online ticketing support accessibility
WCAG 2.1 AA or EN 301 549
Phone support
Yes
Phone support availability
9 to 5 (UK time), Monday to Friday
Web chat support
No
Onsite support
Yes, at extra cost
Support levels
By default we provide support via email and web. Telephone support can be provided on request. Service Desk (Core Hours) 9am – 5pm 5 days per week, Monday to Friday (excluding English Public Holidays). Optional Out of Hours Support: 7am - 7pm 6 days per week, Monday to Saturday (excluding English Public Holidays). Optional Public Holiday Coverage: Should this option be chosen, Solidsoft Reply will provide 24-hour support for all English public holidays that fall within the term of the agreement. Optional 24 x 7 Managed Service: Should this option be chosen, Solidsoft Reply will provide 24-hour support for High/Medium/Low Priority Incidents as determined in the agreement. Optional Technical Design Authority consultant can be offered within the terms of the Managed Service agreement. Managed Service Pricing is determined by the individual customer requirement based on the options detailed above.
Support available to third parties
Yes

Onboarding and offboarding

Getting started
We provide users with a free, downloadable user manual describing registration with the service, initial creation of locations, user counts, etc., barcode scanning setup and general use of the system features. We also provide a series of short on-line videos introducing the main capabilities of the product.

Verilite is designed to be simple and intuitive to use, and does not require extensive training or acquisition of specialised skills. In terms of medicine verification and legal compliance, it is the the responsibility of the National Medicines Verification Organisation (SecurMed, in the UK), working with industry stakeholder organisations, to ensure that pharmacists and wholesalers understand their legal obligations and how to register for access to the EMVS National System.

Users can purchase, renew and manage subscriptions on-line. The web application guides users through a simple registration and initial log-in process and the calibration of their current barcode scanner and computer. Local administrators are guided by the application through the process of setting up locations and user accounts and providing the necessary credentials for accessing the National System.
Service documentation
Yes
Documentation formats
PDF
End-of-contract data extraction
Users are free to export their data from the system at any time before their subscription lapses. If their subscription lapses and they subsequently renew, their existing data will be made available. Their data is stored for several years by default (generally at least one year longer than the expiry date of medicines whose unique identifiers have been verified or decommissioned), in conformance with guidelines for data storage within the EMVS. Data can, however, be deleted on request.

Data is downloaded in comma-separated format (CSV) and opened in a variety of applications including spreadsheets, or imported into a customer's data store.
End-of-contract process
VeriLite is licensed on a per user/per month subscription basis with discounts for 12-month subscriptions and multi-user subscriptions. Subscription renewal is managed through a self-service on-line portal that includes a payment service. Customers can configure subscriptions to auto-renew . Before a subscription expires or is automatically renewed, the user is sent a number of reminders by email.

If a subscription lapses without renewal, the user can no longer access the VeriLite application until they purchase a new subscription. There are no additional costs or constraints.

Using the service

Web browser interface
Yes
Supported browsers
  • Internet Explorer 11
  • Microsoft Edge
  • Firefox
  • Chrome
  • Safari 9+
  • Opera
Application to install
No
Designed for use on mobile devices
No
Service interface
No
API
Yes
What users can and can't do using the API
VeriLite is built over an API that we can offer to customers to facilitate direct integration of their software with the EMVS. The API supports the following:

Parser service - a robust and standards-compliant API for parsing Unique Identifiers (GS1 and German PPN) accurately. The Parser service supports our innovative 'calibration' facility which analyses the barcode scanner / computer combination and dynamically builds maps to handle any mismatches or issues. The Parser service eliminates many causes of 'false positive' alerts.

Verification and decommissioning service. This allows customers to exploit the automated off-line and recovery services and logging services provided by VeriLite when verifying and decommissioning unique identifiers. The API supports all National Systems except Germany. We support both single pack and 'bulk-of-pack' requests.

Reporting. The API provides access to logged data held by VeriLite.
API documentation
Yes
API documentation formats
Open API (also known as Swagger)
API sandbox or test environment
Yes
Customisation available
No

Scaling

Independence of resources
The web service runs on a modern public cloud platform using its Platform-as-a-Service features. It is highly scalable and resilient, and can auto-scale to handle peaks in demand. However, each transaction is very light-weight, and the application can easily deal with significant volumes of work.

VeriLite depends on its connection to the National System. By law, verification of unique identifiers must be carried out by the National System. If the National System is unavailable or running slowly, VeriLite switches to an off-line mode and subsequently recovers automatically when the National System becomes available.

Analytics

Service usage metrics
No

Resellers

Supplier type
Not a reseller

Staff security

Staff security clearance
Conforms to BS7858:2012
Government security clearance
Up to Security Clearance (SC)

Asset protection

Knowledge of data storage and processing locations
Yes
Data storage and processing locations
European Economic Area (EEA)
User control over data storage and processing locations
No
Datacentre security standards
Complies with a recognised standard (for example CSA CCM version 3.0)
Penetration testing frequency
At least once a year
Penetration testing approach
‘IT Health Check’ performed by a Tigerscheme qualified provider or a CREST-approved service provider
Protecting data at rest
  • Physical access control, complying with CSA CCM v3.0
  • Physical access control, complying with SSAE-16 / ISAE 3402
  • Encryption of all physical media
  • Scale, obfuscating techniques, or data storage sharding
Data sanitisation process
Yes
Data sanitisation type
  • Explicit overwriting of storage before reallocation
  • Deleted data can’t be directly accessed
Equipment disposal approach
Complying with a recognised standard, for example CSA CCM v.30, CAS (Sanitisation) or ISO/IEC 27001

Data importing and exporting

Data export approach
VeriLite provides a simple data export facility that allows users to download their data as a file. Users select a period of time for which they wish to export data. To minimise the size of any one download, this period is limited to a few months. However, users can make multiple downloads of data for different periods for any of their data that the system holds.
Data export formats
CSV
Data import formats
Other
Other data import formats
JSON

Data-in-transit protection

Data protection between buyer and supplier networks
TLS (version 1.2 or above)
Data protection within supplier network
TLS (version 1.2 or above)

Availability and resilience

Guaranteed availability
We do not offer SLAs for VeriLite. VeriLite employs a low-cost user subscription model for a simple user interface supporting interaction with a National Medicines Verification System.

SLAs are implemented for the National Systems to which VeriLite connects. Solidsoft Reply is one of two companies that builds and operates National Systems across Europe and must meet the stringent SLA requirements of the European Pharmaceutical industry stakeholders, based on legal requirements for the minimum level of service and performance - e.g., a maximum of 300ms to process at least 95% of all single pack verification and decommissioning requests. If system providers fail to meet their SLAs, they provide service credits under the terms of individual contracts signed with National Medicine Verification Organisations. While these credits to do benefit VeriLite customers directly, they help ensure that users receive the level of service necessary to meet their legal obligations.
Approach to resilience
We use public cloud data centres provided by Microsoft. The web application is hosted using Platform-as-a Service features of the Microsoft Azure platform. It is the responsibility of Microsoft, and central to their commercial interests, to ensure that they provide a high level of availability and resilience. Although Microsoft does not share the technical details of their approach publicly, they do provide their customers, on request, with recent audit reports for a number of compliance, quality and security schemes used in the governance of their platform and infrastructure.

Microsoft runs its Azure platform across a large number of data centres in various geographical regions. We host VeriLite using two European regions (West Europe and North Europe). Each region has several physical data centres which are exploited by the PaaS platform as a single 'virtual' infrastructure to maximise availability and maintain service levels. Microsoft also exploits cross-regional data replication and recovery techniques.
Outage reporting
We communicate with end-users primarily by email. In the event of an outage, our help desk support team communicates with designated customer staff to inform them of the issue. Because VeriLite is a 'gateway' service to a National System, users are directly affected by outages of the National System, even if VeriLite remains functional. For this reason, VeriLite provides automated off-line and recovery features that allow customers to carry on working in the case of a National System outage with minimum disruption and in compliance with legal obligations.

National Systems provide dashboard information on their availability via portals to which our customers have access, and there is also a European-wide scheme for informing stakeholders of any issues, outages or planned maintenance of the European System (a system of connected National Systems).

Identity and authentication

User authentication needed
Yes
User authentication
  • 2-factor authentication
  • Username or password
Access restrictions in management interfaces and support channels
Management access is managed through a dedicated support and operations group. Access is only granted to designated members of staff on the basis of need, and staff are authorised only to the level required to fulfil their function. For example, support staff have the ability to view relevant data in the system to aid investigation, and can use tools to make certain simple changes in order to rectify problems.
Access restriction testing frequency
At least once a year
Management access authentication
  • 2-factor authentication
  • Public key authentication (including by TLS client certificate)
  • Username or password

Audit information for users

Access to user activity audit information
Users contact the support team to get audit information
How long user audit data is stored for
At least 12 months
Access to supplier activity audit information
Users contact the support team to get audit information
How long supplier audit data is stored for
At least 12 months
How long system logs are stored for
At least 12 months

Standards and certifications

ISO/IEC 27001 certification
Yes
Who accredited the ISO/IEC 27001
QMS International
ISO/IEC 27001 accreditation date
02/07/2020
What the ISO/IEC 27001 doesn’t cover
No exclusions.
ISO 28000:2007 certification
No
CSA STAR certification
No
PCI certification
No
Other security certifications
No

Security governance

Named board-level person responsible for service security
Yes
Security governance certified
Yes
Security governance standards
ISO/IEC 27001
Information security policies and processes
Our Information Security Management System comprises an Information Security Policy, Manual and Objectives, is supported by an Access Control Policy, Anti-Piracy Policy, Acceptable Usage Policy, Backup Policy, Bring Your Own Device Policy, Cryptographic Controls Policy, Information Exchange Policy, Leaving Policy, USB Memory Sticks Usage Policy, Network Monitoring Policy, Portable Computer Policy, Password Policy, Remote Access and Mobile Computing Policy, Secure Development Policy and Virus Protection Policy.

The ISMS takes a risk-based approach. Information assets are defined and threats and vulnerabilities for these identified, together with the risk presented. This assessment is used to determine the treatment of the risk and the required controls are implemented (be they technical, physical, policy or training-based). The results are documented in an Asset Risk and Treatment Register, which is reviewed at least annually.

Our reporting structure includes Information Security representation on the Leadership Team and a separate Security Manager. A Security Committee meets every two months. The Security Manager is supported in managing the ISMS by the three-strong Quality Management Team, which includes a certified ISO 27001 internal auditor. This team oversees compliance and training in the ISMS. Management reviews, full system internal and independent external audits are carried out annually.

Operational security

Configuration and change management standard
Supplier-defined controls
Configuration and change management approach
Our change and configuration management processes are based on ITIL. Our Change Manager holds a weekly Change Advisory Board meeting which includes the Security Manager. We follow a defined risk assessment approach for changes which includes consideration of security impacts. Changes are recorded via the Freshservice IT Service Management platform. Configuration management of virtual infrastructure and platforms is performed (and tracked) using the Microsoft Azure Portal. Configuration management of application code, test cases, test plans, builds, releases and deployment pipelines is performed via the Microsoft Azure DevOps tool. Documentation versioning follows our procedure for document control.
Vulnerability management type
Supplier-defined controls
Vulnerability management approach
Assessment of threats at a high level is made via the Asset Risk and Treatment Register, a key component of the Information Security Management System. Penetration testing is conducted annually. Microsoft patching is typically applied monthly in a staggered model to staging environments prior to deployment onto production. In addition we monitor Microsoft sites and other security sources directly and via email subscription for details of security vulnerabilities. The vulnerabilities are reviewed to assess their impact and criticality against our Patch Management Policy and to identify if accelerated deployment is necessary to the production environment.
Protective monitoring type
Supplier-defined controls
Protective monitoring approach
Our operations team monitors the services against a wide range of parameters. Anomalous activities, which may indicate security or other issues, are identified through visual dashboards and alerting. Alerts automatically generate support incident tickets. Raised incidents are managed through our Incident Management or High Priority Incident Management processes. We prioritise incidents on impact, urgency and response times, typically depending on the categorisation defined in customer Service Level Agreements. Data protection breaches are managed in accordance with agreed customer or internal breach management procedures and regulations such as GDPR.
Incident management type
Supplier-defined controls
Incident management approach
Users report incidents via our Service Desk and/or ticketing system (part of our Freshservice IT service Management system). Incidents are categorised according to severity and managed in accordance with our Incident Management or High Priority Incident Management processes. The Operations Team maintain a knowledge management system, which includes details of responses to common incidents. Incidents that reveal underlying issues trigger our Problem Management process, which includes identification and recording of workarounds for Known Errors. Significant incidents are reported via periodic Service Management Reviews (at least monthly). Major incident reports may be prepared in some cases (contract and severity dependent).

Secure development

Approach to secure software development best practice
Independent review of processes (for example CESG CPA Build Standard, ISO/IEC 27034, ISO/IEC 27001 or CSA CCM v3.0)

Public sector networks

Connection to public sector networks
No

Pricing

Price
£25 to £45 a user a month
Discount for educational organisations
No
Free trial available
No

Service documents

Return to top ↑