Our services
Our team of experts boasts extensive experience and a profound understanding of pharmaceutical industry processes.
We assist our clients in efficiently managing their data, a critical requirement in the ever-advancing technological landscape of the pharma industry.
We’re proud of our annual Customer Satisfaction Survey results, which consistently reflect complete satisfaction with our services, from implementation to support.
Implementation
READY! Implementation Process
- Flexible Installation:
- READY! can be installed on your servers or hosted in the cloud.
- We offer remote implementation, including comprehensive training sessions.
- Data Analysis and Migration:
- Our team assists in analyzing your existing product information.
- We execute automatic migrations wherever possible.
- Requirements Analysis:
- The implementation process begins with a detailed analysis of user requirements.
- We document proposed solutions based on this analysis.
- Collaborative Effort:
- Our consultants, engineers, and key users actively collaborate to ensure functional, user-friendly solutions.
- These solutions align with your requirements from the outset.
- Ongoing Support:
- Our initial and ongoing consulting services guarantee that the solution is configured correctly for your business.
- We ensure that it remains consistently updated.
Migration
- Extensive Expertise: We bring extensive experience in regulatory data migration, garnered from the successful execution of numerous projects.
- Integral to READY! Implementation: Migration is an integral part of the READY! implementation process and is typically the first inquiry from our clients.
- Thorough Data Analysis: Before migrating data and documents, we conduct a comprehensive analysis, focusing on data location, quality, and granularity.
- Automated Data Migration Tools: In subsequent stages, we develop tools designed to facilitate automated data migration into READY!
- ISO IDMP and SPOR Standards: READY! is built on ISO IDMP standards and SPOR, ensuring seamless data migration.
- Expert Data Migration Team: Our highly skilled team of experts specializes in migrating data from various third-party systems. Thanks to Nanokinetik’s data migration services and tools, manual data input from your existing solution or spreadsheets becomes unnecessary.
Integrations
Role of Integrations: Integrations play a crucial role in the implementation of READY!, ensuring seamless data exchange and enhanced functionality.
Comprehensive Data Integration Services:
- We offer comprehensive data integration services, enabling automatic data retrieval, validation, and standardization of product data from various sources.
Common Integrations:
- READY! is frequently integrated with SAP, streamlining data management processes.
- In addition to SAP, it’s common to integrate READY! with your existing systems, including:
- Document management systems like SharePoint.
- Customer Relationship Management (CRM) platforms.
- eCTD publishing tools.
Versatile System Integration:
- READY! seamlessly integrates with a variety of systems, including:
- SAP, Oracle, and other ERP systems.
- Existing product databases.
- Existing Document Management Systems, including Microsoft SharePoint and OpenText Documentum.
- Various tracking tools and Regulatory Information Management (RIM) solutions.
- Publishing tools such as eCTD and NeeS.
Secure Integration Interfaces:
- For secure information exchange, READY! offers the following integration interfaces:
- Web services (over plain HTTP or using SSL for added security).
- FTP and SFTP interfaces (with optional use of XLS message format).
Validation
Validation Requirement:
- READY! needs to undergo validation when used as part of your validated GxP environment or Pharmacovigilance system.
Key Focus:
- Computer system validation is our primary focus in the development, implementation, and maintenance of our software.
Protocol Compliance:
- Our validation protocol aligns with the requirements of the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Our clients have successfully passed numerous audits.
Ensuring Proper Functionality:
- By validating your computer system, you confirm that it functions correctly and aligns with the specified requirements. This is essential for ensuring data consistency and reliability.
Expert Validation Services:
- Our certified experts can assist you through all stages of the validation process, including:
- Assistance in creating user requirement specifications.
- Performing risk assessment and risk-based validation planning.
- Creating functional and design specifications.
- Providing support during validation test execution (DQ, IQ, OQ, and PQ).
- Creating comprehensive validation reports.
GAMP®5 Principles:
- We are trained and experienced in the validation of computerized systems according to GAMP®5 principles. By introducing practical approaches, we can help you reduce the costs associated with the validation process.
Service Level Agreement (SLA)
The SLA includes comprehensive maintenance and support services designed to ensure the continuous operation and validation of READY! These services encompass:
- New Software Versions:
- Installation of new software versions.
- Validation of new versions.
- SPOR Controlled Vocabularies:
- Updates of the SPOR controlled vocabularies as defined by the EMA.
- Server Environment Control:
- Complete control of the server environment running READY! systems.
- Control updates of the SQL Server.
- Control updates of the operating system on the server.
- System administration.
- Performance Monitoring:
- Monitoring the system performance.
- SQL Server performance monitoring and optimization.
- Application performance monitoring and optimization.
- 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.
- Data Management:
- Daily backup check.
- Daily checking of security logs.
- Maintenance of the system documentation.
- Change management (keeping necessary records regarding system changes to ensure regulatory compliance).
- Consultation and Expert Advice:
- Consultation and expert advice on any topic relevant or related to the system use.
- Expert knowledge within NANOKINETIK (e.g., computer system validation, medicinal product data structures, SQL optimization, business continuity management, etc.).
Server Hosting & Cloud Services (SaaS)
We offer Server hosting and Cloud services (SaaS) to ensure you benefit from a robust and dependable READY! system. Our services come with the assurance that your software is professionally managed in a secure, stable environment.
Accessibility and Convenience:
- Access READY! via a browser from any location.
- We handle application and server management, as well as your data, in a highly secure and trusted environment.
Effortless Upgrades:
- We take care of all software upgrades, allowing you to focus on your core business activities.
- Optional disaster recovery packages minimize the risk of critical downtime and support business continuity strategies.
Cost-Effective Solutions:
- Leasing a business-information system, as opposed to purchasing one along with associated support equipment, reduces initial investment costs.
- Our SaaS (Software as a Service) and Cloud services offer low initial expenses and flexible payment options, enhancing budget control and expediting the procurement process.
READY! SOLUTIONS
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READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
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Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
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Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
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Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
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Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
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Development
Track milestones and store documents created in the development of a new medicine.
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Quality Assurance
Manage processes, documents, and products in one integrated platform.
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Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
READY!® stands for: REgulated Affairs DiarY.
READY! is built on the premise that companies require up-to-date, current information about their products in all their iterations.
It has been developed to address the specific needs of managing both structured (IDMP medicinal product information) and unstructured information (documents, forms, records) within the pharmaceutical industry.
