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DIGITECTURE LIMITED

IDMP FHIR compliant Data and API Design

Delivering IDMP, MEDDRA, FHIR compliant design for Data warehouse and Reporting platforms. Expertise in Azure Fabric, Synapse Analytics, Azure Data factory, Azure Data Lake, PowerBi and Microstrategy

Features

  • SPOR and IDMP compliance
  • SPOR Reference Data Services
  • IDMP Data Standardization
  • Regulatory Information Management
  • Medicines Data Integration
  • SPOR Data Exchange
  • SPOR Data Quality Management
  • EHR data exchange services
  • EHR solution design

Benefits

  • Gain valuable insights from medicinal product data through analytics
  • Facilitate collaboration between regulatory affairs, NHS partners and supply chain
  • Unified view of Medicinal and Medical devices product information
  • Mitigate risks associated with data inconsistency, incompleteness, or non-compliance
  • ensure data quality, integrity, enhancing trust in medicinal product information
  • Standardize data formats to facilitate interoperability between Health agencies

Pricing

£350 to £1,000 a unit a month

Service documents

Request an accessible format
If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at anil.piplani@digitecture.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.

Framework

G-Cloud 14

Service ID

7 1 1 0 2 1 6 7 1 2 2 5 4 8 9

Contact

DIGITECTURE LIMITED Anil Piplani
Telephone: 07513935465
Email: anil.piplani@digitecture.co.uk

Planning

Planning service
Yes
How the planning service works
Our Analysis and Design service for an Cloud-hosted IDMP Data reporting platform offers a comprehensive solution tailored to the specific needs of NHS, government regulators and health agencies seeking to comply with IDMP regulations. Leveraging the power and scalability of Microsoft Azure, our service begins with a thorough analysis of the client's requirements, existing infrastructure, and regulatory obligations. We collaborate closely with stakeholders to understand their reporting needs, data sources, and integration requirements.

Based on this analysis, we design a robust and scalable architecture for the IDMP Data reporting platform, utilizing Azure services such as Azure SQL Database, Azure Data Factory, Azure Analysis Services, and Power BI. Our design ensures data security, compliance with regulatory standards, and seamless integration with existing systems. We prioritize scalability and performance to accommodate growing data volumes and ensure timely reporting.
Planning service works with specific services
No

Training

Training service provided
Yes
How the training service works
Regulatory Compliance Training: Training sessions focused on educating users about IDMP regulations, standards, and reporting requirements. This includes understanding the importance of data accuracy, completeness, and timeliness for regulatory submissions, as well as compliance with ISO standards and guidelines set forth by regulatory agencies such as the MHRA, ICH, FDA and EMA.
Technical Training: Training for IT professionals responsible for supporting the IDMP data platform, including database administrators, developers, and technical support staff. Topics may include platform architecture, data integration methods, API usage, and troubleshooting technical issues.
Customized Workshops and Webinars: Interactive workshops and webinars tailored to specific organizational needs or challenges related to the IDMP data platform. These sessions may focus on advanced features, data analysis techniques, or specialized topics requested by stakeholders.
Documentation and Knowledge Base: Development of comprehensive documentation, user guides, and knowledge base articles to supplement training materials and provide ongoing support to users. This includes tutorials, FAQs, and troubleshooting guides accessible through the platform's interface or a dedicated portal.
On-Demand Training Resources: Provision of on-demand training resources such as video tutorials, online courses, and self-paced learning modules to accommodate diverse learning styles and preferences.
Training is tied to specific services
Yes
Services the training service works with
  • Microsoft Azure
  • Amazon AWS

Setup and migration

Setup or migration service available
Yes
How the setup or migration service works
In the government sector, our analysis and design service for migrating to an Cloud-hosted IDMP Data reporting platform ensures seamless transitions from on-premise or existing cloud environments. We assess current infrastructure, regulatory requirements, and data migration needs, designing a scalable Cloud architecture that meets compliance standards. Our expertise streamlines the migration process, optimizing performance, security, and integration with existing systems, ensuring government agencies effectively manage medicinal product data while meeting IDMP regulations.
Setup or migration service is for specific cloud services
Yes
List of supported services
  • Microsoft Azure
  • Amazon AWS

Quality assurance and performance testing

Quality assurance and performance testing service
Yes
How the quality assurance and performance testing works
We can help the NHS organization, regulatory and other healthcare agencies in quality assurance of their IDMP compliant services
Data Quality Checks: Implement comprehensive data quality checks to validate the accuracy, completeness, and consistency of IDMP data. This includes verifying data against predefined rules, identifying anomalies or discrepancies, and performing data cleansing and enrichment as needed.
Regulatory Compliance: Ensure compliance with IDMP regulations and standards, including ISO standards and regulatory requirements set forth by agencies such as the MHRA, ICH, FDA and EMA. Conduct regular audits and assessments to verify adherence to regulatory guidelines and documentation standards.
Performance Testing: Conduct performance testing to evaluate the responsiveness, scalability, and reliability of the IDMP Data platform. This includes stress testing, load testing, and endurance testing to assess system performance under various usage scenarios and peak loads.

Security testing

Security services
No

Ongoing support

Ongoing support service
No

Service scope

Service constraints
None

User support

Email or online ticketing support
Email or online ticketing
Support response times
Email support is offered only on weekdays and standard response time is 3 to 5 working days. Support is provisioned only for the technology solutions delivered by the company and doesn't include consultancy on IDMP, SPOR or any Data platforms used in the solution
User can manage status and priority of support tickets
No
Phone support
Yes
Phone support availability
9 to 5 (UK time), Monday to Friday
Web chat support
No
Support levels
For IT services related to IDMP SPOR and medicines data management, support is typically offered across two levels: Basic and Premium. Basic support provides helpdesk assistance during standard business hours and is often included in base service fees. Premium support offers dedicated teams, priority response for critical incidents, proactive monitoring, and customized training. Costs vary depending on the level of support and the organization's size and requirements.
Tehcnical Account Manager services are offered in Premium support. Basic support is offered only via email

Resellers

Supplier type
Not a reseller

Staff security

Staff security clearance
Conforms to BS7858:2019
Government security clearance
Up to Baseline Personnel Security Standard (BPSS)

Standards and certifications

ISO/IEC 27001 certification
No
ISO 28000:2007 certification
No
CSA STAR certification
No
PCI certification
No
Cyber essentials
No
Cyber essentials plus
No
Other security certifications
No

Social Value

Social Value

Social Value

  • Covid-19 recovery
  • Equal opportunity

Covid-19 recovery

We endeavour to support organisations in implementing Identification of Medicinal Products (IDMP) standards can significantly enhance a health organization's resilience to pandemics like COVID-19 in several ways:

Improved Drug Traceability: IDMP facilitates comprehensive tracking and tracing of medicinal products throughout the supply chain.
Enhanced Pharmacovigilance: IDMP promotes the standardized collection, processing, and exchange of pharmacovigilance data.
Interoperable Data Exchange: IDMP standards promote interoperability by standardizing data formats and terminologies for medicinal product information. This interoperability facilitates seamless data exchange between health organizations, regulatory agencies, and partners
Facilitated Regulatory Compliance: Adhering to IDMP standards ensures that health organizations maintain accurate, consistent, and up-to-date information about medicinal products.

Equal opportunity

We are committed to building an organisation that provides fair and equal opportunities to all employees and job applicants, regardless of their race, ethnicity, gender, age, sexual orientation, disability, religion, or any other characteristic protected by law.
Recruitment and Hiring Practices: Our company's recruitment and hiring processes are fair, unbiased, and free from discrimination.
Diverse Workforce: We actively seek to build and maintain a diverse workforce that reflects the broader community. This involves recruiting employees from various backgrounds and demographics, including those traditionally underrepresented in the tech industry.
Equal Access to Opportunities: We believe in providing equal access to training, professional development, and advancement opportunities for all employees, regardless of their background or identity.
Compliance with Laws and Regulations: We adhere to all applicable laws, regulations, and guidelines related to equal employment opportunity, including those governing nondiscrimination, harassment, and accommodation.

Pricing

Price
£350 to £1,000 a unit a month
Discount for educational organisations
No

Service documents

Request an accessible format
If you use assistive technology (such as a screen reader) and need versions of these documents in a more accessible format, email the supplier at anil.piplani@digitecture.co.uk. Tell them what format you need. It will help if you say what assistive technology you use.