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 stage of retirement. This is clearly stated in Annex 11 of the European GMP and the FDA’s 21 CFR Part 11.
Based on our experience in the Life Sciences industry, we understand that the validation of READY! is a fundamental requirement for our clients.
The Nanokinetik Quality Management System (QMS) is based on our extensive industry experience and up-to-date with the latest regulatory developments and industry trends.
We have successfully passed all audits performed by our clients.
GAMP5 methodology followed:
- Stage 1: Planning and Specification
- Stage 2: Installation on the test and production environments
- Stage 3: Installation qualification (IQ)
- Stage 4: System acceptance testing (OQ and PQ)
- Stage 5: System operation
Validation documentation delivered:
- Project implementation plan
- Validation plan
- Validation risk assessment
- URS, FS, RTM
- Guides (User, Admin)
- Training records and materials
- Project tracking documentation (meeting minutes, progress reports, etc.)
- IQ (plan, records)
- OQ (protocol, test scenarios & cases, records, report)
- PQ (protocol, test scenarios & cases, records, report)
- Validation report
- Handover report
Preparation of IQ/OQ documentation and execution of the protocols is performed by the client and Nanokinetik.
PQ scripts preparation and execution is performed by the client and are supported by Nanokinetik.
Nanokinetik provides hands-on support for validated implementations through the “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Replace Excel spreadsheets, shared drives, and outdated regulatory databases.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.
