Are you READY! ?
READY! is a web-based solution based on IDMP standards that enables pharmaceutical companies to manage their medicinal product information, safety data, and documents in one validated environment.
Why READY! ?
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
The biggest problem companies face today is how to manage the current information about their products, plus manage all of the changes.
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.
READY! is a secure web-based solution that enables collaboration and reuse of the same information across the enterprise.
READY! is configurable and enables quick implementation of any process in a validated environment. The implementation of READY! is based on process templates.
This approach lowers the cost of installation, validation, and maintenance of such system in medium sized and large pharmaceutical companies.
For example, regulatory affairs specific configuration of READY! serves as a complete RIMS system that enables tracking and reporting capabilities over the complete regulatory lifecycle of medicinal product base on SPOR data.
Another example is management of ePI documents.
READY! has been designed and developed to meet stringent regulatory and technical requirements. These requirements are regulated by international standards, standardisation bodies, and rules and regulations of regulatory bodies, including 21 CFR part 11 requirements for validation of computer systems.
Our clients report an estimated 20% increase in overall efficiency using READY!. They can dedicate time to scientific work instead of populating Excel spreadsheets and manually creating reports. This can be translated into 20% more scientific work done, and measured in the salaries of an additional 20% more staff.
Investment into READY! returns in less than one year!
READY! is being used by the industry and regulators since 2012.
What is READY! ?
READY! stands for REgulated Affairs DiarY.
READY! comprises various configurations of the same software platform:
- Product database and Activity tracking
- Document management and Dossier compilation
- ISO IDMP/Article 57 reporting
The complexity of managing information is simply reduced to configuring a business process.
The user interface is web-based and users simply like it.
READY! is:
- Web-based
- Easy-to-use
- Supports remote work and can be used in many locations including at home
- Makes tracking, planning, and reporting automatic
- Creates automatic alerts for important dates
- Information can always be exported to Excel
- No installation is needed on local computers
Our innovative approach in the design of READY! translates into more work done with less stress.
Instead of useless time spent populating Excel worksheets, the professionals can focus on scientific work.
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 fundamental necessity for companies to have up-to-date and comprehensive information about their products in all their variations.
It has been meticulously developed to address the unique requirements of managing both structured (IDMP medicinal product information) and unstructured data (documents, forms, records) within the pharmaceutical industry.
