Our services

Our experts have many years of experience and a deep understanding of processes in the pharmaceutical industry.

Our expertise and practical approach enable clear and efficient communication with our clients. We are proud that our annual Customer Satisfaction Survey demonstrates total satisfaction with our services, from implementation to support.

All of our projects have been successful and finished within the agreed-upon time and price.

Implementation

Our consultants understand the importance of accurate medicinal product information to your business and have the training and background to successfully implement such system in your business environment.

Companies usually start using READY! with the product database configuration.

READY! document management configuration is usually implemented in the second step, using medicinal product information to populate documents and dossier attributes using SPOR data. In doing so, the implementation of workflows is performed faster, as the complexity is reduced to focusing on document and dossier lifecycles.

READY! can be installed on your servers, or we can arrange hosting for a Cloud-based installation. Implementation can be done remotely, including trainings.

During the implementation, we will help you analyse your existing product information and execute automatic migration whenever possible.

Implementation of the system begins with a detailed user requirements analysis and a documented proposal of the requirements resolution.

Our consultants, engineers, and key users work on implementing solutions to ensure that our solutions are functional, user-friendly, and meet your requirements from the start.

Initial and on-going consulting services ensure the solution is set up the right way for your business and always updated.

Migration

We have extensive experience in regulatory data migration based on the many projects that we have implemented.

Migration is always part of the implementation of READY!, and is the first question that our customers ask.

Before the data and the documents are migrated, we analyse the location, quality, and granularity of your data.

In the following steps, we prepare tools that will help you migrate the data into READY! automatically.

READY! is based on ISO IDMP standards and SPOR, once the data is migrated.

Migration services are performed by our skilled team of experts who have experience migrating data from a variety of third-party systems. With Nanokinetik’s data migration services and tools, there is no need for manual data input into the system from your existing solution or other spreadsheets.

Integration

Integrations always play a part in READY! implementation.

We can provide data integration services for automatic data retrieval, validation, and standardisation of product data from various data sources.

We usually integrate READY! with SAP.

It is not unusual to also integrate READY! with your existing document management system, Sharepoint, CRM (Customer Relationship Management) or eCTD publishing tools.

READY! can be integrated with the various systems:

  • SAP, Oracle, and other ERP systems
  • Existing product databases
  • Existing Document Management Systems, including MS SharePoint and OpenText Documentum
  • Various tracking tools and RIM solutions
  • Publishing tools (eCTD and NeeS)

The following integration interfaces are available for the secure exchange of information:

  • Web services (Over plain HTTP or by using the SSL connection)
  • FTP and SFTP interfaces (XLS message format can also be used optionally)

Validation

READY! needs to be validated if used as part of your validated GxP environment or Pharmacovigilance system.

Computer system validation is our key focus in the development, implementation, and maintenance of our software.

Our validation protocol is in line with EMA and FDA requirements, and our clients have successfully passed many audits.

By validating your computer system, you confirm that the system is functioning properly and according to the requirements’ specifications, which is important for data consistency and reliability.

Our certified experts can help perform validation through all stages of the validation process:

  • Assistance in creating user requirement specifications
  • Performing risk assessment and risk-based validation planning
  • Creating functional and design specification
  • Assistance through validation test execution (DQ, IQ, OQ, and PQ)
  • Creating validation reports.

We are trained and experienced in the validation of computerised systems according to GAMP®5 principles, and by introducing practical approaches we can help you decrease the costs of the validation process.

Service Level Agreement (SLA)

The SLA includes maintenance and support services to keep the READY! up and running and validated:

  • New software versions installation
  • Validation of new versions
  • Updates of the SPOR controlled vocabularies as defined by the EMA
  • Complete control of server environment running READY! systems
    • Control updates of the SQL Server
    • Control updates of the operating system on the server
    • System administration
  • Monitoring the system performance
    • SQL Server performance monitoring and optimisation
    • Application performance monitoring and optimisation
    • Antivirus performance monitoring
  • Corrective and Preventive actions
    • Root cause analysis
    • Correction of the problem
    • Corrective action design, performing, and record-keeping
    • Preventive action design, performing, and record-keeping
  • Daily backup check
  • Daily checking the security logs
  • Maintenance of the system documentation
  • Change management (keeping necessary records regarding system changes, thus ensuring regulatory compliance)
  • Consultation and expert advice on any topic relevant or related to the system use, and/or any other expert knowledge within NANOKINETIK (e.g. computer system validation, medicinal product data structures, SQL optimisation, business continuity management, etc.)

Server Hosting & Cloud Services

We can offer Server hosting and Cloud services to ensure that you benefit from a comprehensive and reliable READY! system, combined with insurance that your software is professionally managed in a secure, stable environment.

Our services enable you access to our software via a browser, from any location.

We take care of the management of the applications, servers, and your data in a highly secure and trusted environment.

We manage all software upgrades, enabling you to focus on your business. Optional disaster recovery packages reduce the risk of business-critical downtime and support business continuity strategies.

Leasing a business-information system versus purchasing such a system and the associated support equipment has the advantage of reducing investment costs.

Our SaaS and Cloud services offer you low initial costs and flexible payment options to improve your budget control and speed up the procurement process.