Built on established SoftGroup technology.
- •Validated serialization platform
- •Native interoperability with the existing network
- •Regulatory connectivity across markets
- •Governed serialized data
MANAGED SERIALIZATION COMPLIANCE
Keep serialization compliance moving after go-live.
Serialization compliance doesn't end at implementation. Through an agreed service arrangement, specialist providers can manage recurring activities such as exceptions, partner-data coordination, application changes and validation support. Built on SoftGroup technology, with oversight and regulatory accountability remaining with your organisation.
Established SoftGroup technology✓Native interoperability✓Managed compliance available
WHY CONSIDER MANAGED COMPLIANCE
Implementation ends. Compliance operations continue.
Exceptions, verification activity, partner changes, validation, reporting and controlled releases remain recurring work. The question is not only which system you use, but which responsibilities still need to sit inside your own team.
Choose the daily compliance work you need help with.
- ✓Monitoring and specialist review
- ✓Exception and connection coordination
- ✓Validation support and evidence
- ✓Clear governance and escalation
MANAGED SERVICES
Four service areas for your daily compliance workload.
Choose the support your team needs. Activities, response times and responsibilities are agreed with your service provider.
01
Compliance Operations
Exception handling, verification-alert triage, partner-data coordination and routine reporting. Agree response windows, approvals and escalation for your operation.
02
Application Management
Application administration, monitoring and configuration, with controlled changes and release support for your serialization environment.
03
Quality & Validation
Validation planning and support, evidence management, controlled change and quality documentation for regulated operations.
04
Advisory & Lifecycle
Plan launch readiness, provider change, migration and partner onboarding. Prepare for new products and supported markets as your business grows.
REGULATORY SOLUTIONS
Serialization support for the markets you serve.
Apply the same four service areas to your regulatory environment. Confirm the technology, daily activities and delivery support your organisation needs.
AssureTrace DSCSA
For pharmaceutical companies managing US serialization requirements. Bring technology, trading-partner exchange and daily compliance activities into one agreed plan.
- Trading-partner data coordination and supported exchange
- Verification alerts, exceptions and escalation
- Application changes, validation support and reporting
AssureTrace FMD
For pharmaceutical companies managing EU FMD serialization. Organise recurring compliance work around your products, connected systems and market requirements.
- Verification-alert triage and exception coordination
- Product and partner-data coordination
- Application management, validation support and controlled change
Coverage, activities and response times are confirmed for your markets and service agreement. Your organisation retains oversight and regulatory accountability.
Understand how service delivery works →IS MANAGED COMPLIANCE RIGHT FOR YOU?
When daily compliance needs more than your team can spare.
A lean internal team
Daily serialization work relies on a few people who also carry other responsibilities.
Frequent regulatory or market change
New requirements, markets, products, and releases create repeated validation and coordination work.
A complex partner network
CMOs, 3PLs, wholesalers, and other partners make connection monitoring and change coordination harder to sustain internally.
A recurring exception workload
Alerts, verifications, investigations, and evidence preparation compete with other quality, supply-chain, and IT priorities.
A provider review or renewal
A contract, upgrade, or service decision creates a natural point to compare the current setup with a managed alternative.
A first commercial launch
A launch team can establish reliable compliance operations without building the entire specialist function internally.
HOW THE SERVICE WORKS
Specialists handle the agreed work. You stay in control.
Your service combines established SoftGroup technology with specialist operational support. You retain regulatory accountability and the approvals your organisation needs.
Technology: SoftGroup’s platform supports serialization, regulatory connectivity and partner data exchange.
Operations: your provider handles the daily compliance activities included in your service.
Quality: agree the validation support, change controls and documentation needed for your environment.
Control: agree responsibilities, service reporting and escalation so your team knows who handles what.
ASSESS THE CASE
Find out where your compliance workload could improve.
Explore your recurring workload, partner dependencies and operating costs. Use the results to compare your current setup with the support your team needs.
Open the Serialization Resilience CheckASSESS ONLINE
Use the tools online
Review partner dependencies, migration effort and operating costs at your own pace.
REQUEST THE TOOLS
Receive standalone versions
Request the network and cost tools without entering sensitive operational information into the website.
DISCUSS YOUR RESULTS
Discuss the assessment
Talk through your results and explore the support available for your organisation.
START A CONVERSATION
Discuss the operating model that fits your organisation.
Tell us where daily compliance is stretching your team. Explore specialist support for the work you want to reduce.