Quality and Validation
READY! is fit for the purpose from a regulatory and business perspective, including operational benefits.
Validation is an integral part of the computer system life cycle, from the planning stage to the retirement stage, as clearly stated in Annex 11 of the European GMP and FDA’s 21 CFR Part 11 regulations.
Drawing from our extensive experience in the Life Sciences industry, we recognize that the validation of READY! is a fundamental requirement for our clients.
The Nanokinetik Quality Management System (QMS) draws from our extensive industry experience and remains updated with the latest regulatory developments and industry trends.
We are proud to share that we have successfully passed all audits conducted by our clients.
Our approach aligns with the GAMP5 methodology, encompassing the following stages:
- Planning and Specification
- Installation on the test and production environments
- Installation qualification (IQ)
- System acceptance testing (OQ and PQ)
- System operation
Additionally, we hold ISO 9001 certification.
Validation documentation delivered:
- Project implementation plan
- Validation plan
- Validation risk assessment
- User Requirement Specification (URS), Functional Specification (FS), Requirement Traceability Matrix (RTM)
- Guides (User and Admin)
- Training records and materials
- Project tracking documentation (meeting minutes, progress reports, etc.)
- Installation Qualification (IQ) documentation (plan and records)
- Operational Qualification (OQ) documentation (protocol, test scenarios and cases, records, report)
- Performance Qualification (PQ) documentation (protocol, test scenarios and cases, records, report)
- Validation report
- Handover report
The preparation of IQ/OQ documentation and the execution of the protocols are performed jointly by the client and Nanokinetik.
PQ script preparation and execution are managed by the client, with support from Nanokinetik.
Nanokinetik offers hands-on support for validated implementations through “Service Level Agreements(SLA).”
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 based around the idea that companies need updated, current information about their products in all of their iterations.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.
