Using READY! will increase efficiency in the approval of PI during regulatory procedures, and later dissemination in printed and in electronic format (ePI).
Authorised, statutory product information for medicines include:
PI must be updated as soon as changes to the SmPC and PL are authorised by regulatory authorities.
READY! tracks changes across all relevant PI annexes and products, and it eliminates many manually performed tasks and redundancies that are potential sources of error.
Using the READY! automated process simultaneously changes, or flags for change, all locations where the information occurs, leading to faster updates and reducing the risk of introducing errors.
PI contains the same information linked to several products and strengths registered in several countries, each of which has to be changed individually in case of an update to the information.
The approval process of PI documents in READY! to the metadata about medicinal products stored in READY!.
Each document gets the attributes from the respective marketing authorisation metadata.
For example:
PI is updated as soon as changes to the SmPC and PL are authorised by the regulatory authorities.
The approval process can be based on electronic signatures, eliminating the need for paper-based signatures and paper approvals.
The result is a complete history (versions) of each PI document, and for every Marketing Authorisation you can always find approved and effective PI documents.
The most up-to-date PI version is always easily available.
Various departments, including Pharmacovigilance, can access this resource more easily for studies of active substances, indications, target populations, adverse events, and many other pieces of information contained in PI.
Approved and effective PI documents are available across the organisation and partners, including CROs, CMOs, translators, and medical professionals.
READY! also fully supports the management of the forthcoming electronic PI (ePI) in a semi-structured format created using common EU electronic standards.
READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
Development
Track milestones and store documents created in the development of a new medicine.
Quality Assurance
Manage processes, documents, and products in one integrated platform.
Are you READY! ?
Manage product information, safety data, and documents in one validated environment.
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.
