Our experts have at least 15 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.
We have a team of expert consultants available to deliver our implementation and training services.
Our consultants understand the importance of our products to your business and have the training and background to successfully implement the system in your business environment.
Companies usually start using READY! with the product database implementation.
The READY! Product database can be up and running in two weeks.
Document management is implemented in the second step, using product database information to populate documents and dossier attributes. In doing so, the implementation of document management is performed more easily and 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.
Initial and on-going consulting services ensure the system is set up the right way for your business and helps to identify new opportunities.
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 potential 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.
We take care of the data migration process in order to bring over data from old systems and other file types during the READY! implementation process. 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.
Integrations always play a part in READY! implementations.
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, and CRM (Customer Relationship Management).
To control user access to READY!, it uses an Active Directory for passwords management.
READY! can be integrated with the following 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)
If READY! will be used as part of your validated GMP environment or Pharmacovigilance system, it needs to be validated.
Our validation protocol is in line with EMA and FDA requirements, and our clients have successfully passed many audits.
Computer system validation is the key activity in the development, implementation, and maintenance of our software products.
Validation is an integral part of the computer system life cycle, from the planning stage to the stage of retirement. This is clearly stated in Annex 11 of the European GMP and the FDA’s “General Principles of Software Validation.”
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 (controlled and in agreement with the Client)
Validation of new versions (preparation of validation documentation and reports; the Client has the responsibility to perform test scripts)
Updates of the 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
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 Cloudservices 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.