READY! is used to support your most important company objectives, namely guaranteeing the safety, efficacy, and quality of your products (EU Regulation No. 1235/2010 and Directive 2010/84/EU).
READY! gives you access to one, single product and safety database with an up-to-date overview of all products and activities with dedicated responsibilities.
QPPV and other managers have prompt access to current, important information and activities about their products, and can use the system to report to, or alert internal and external stakeholders.
READY! is a full featured safety database through which you can easily handle your cases and receive alerts on important dates and deadlines; keep track of your activities, cases and documents for compliance and audit purposes; and electronically exchange ICSRs.
The ICSRs are compatible with the new ICH E2B(R3) standard including the connection to the Eudravigilance Gateway.
With READY! you get an on-demand, easy management overview of all pharmacovigilance matters within the company, as well as insight into the performance of your internal business processes.
The pharmacovigilance department benefits from fast and easy creation of documents by exploiting all benefits of electronic templates, workflows and automatic data population.
READY! enables your company to comprehensively monitor all activities and documents required by the EU GVP, while respecting all technical requirements of EU and US regulators (such as 21 CFR Par 11 or EU Annex 11), thus providing a tool for achieving regulatory compliance.
- Medicinal product database
- Safety database
- Full support for ICRS submissions
- Full support for XEVMPD and the coming ISO IDMP submissions
- Change management and alerting
- An overview of all company products (in development and later including regulatory status – authorised, pending registration, change ownership, suspended, etc. – marketing status, sunset clause, launch date, MAH, country, etc.)
- QPPV and local representative per product and country
- PSMF location per product
- An overview of products belonging to DDPS, PSMF, or products with no DDPS or PSMF
- Life cycle management of PSMF with annexes, SOPs, quality manuals (versions, document status, responsibilities, etc.)
- Life cycle management of risk management plans per product with their regulatory status, version, and dates (change date, effective date, version date, etc.)
- PSUR cycles
- DLPs per product
- An overview of PSURs per product and country
- Plan and track submissions of all PV-related activities (renewals, PSURs, safety variations, changes to RMP, etc.)
- An overview of product information (SmPC, PIL, labelling) per product and country with defined regulatory and internal statuses
- An overview of current labelling in the packs on the market (per product and country)
- An overview of products with additional monitoring
- An overview of literature search per product: global or local
- An overview of clinical trials
- An overview of PASS
- An overview of all partners per product (formulation development, clinical studies, pharmacovigilance, in-licence, out-licence, co-marketing, etc.)
- An overview of audits and inspections per product or PV system
- An overview of all planned, active, and finished regulatory activities
Moreover, the system alerts you EVERYDAY which activities and tasks you need to complete to avoid delays and non-compliance.
Last, but not least, and still very important:
- Standard and general reports
- Reports that can be tailored and customised to an organisation’s specific needs
- Export of reports to a different format (e.g. Excel, .xml, .pdf, etc.)
- Possibility for various searches, general or customised, private, or public where you can access the required information with one click
- Managers will have the prompt knowledge of dedicated activities, tasks, and projects for each employee to help them identify the people they need to achieve their organisational objectives
With READY! you can identify which products are affected, have an overview of current PV and RA activities (planned, active, and finished), and then prioritise and plan the implementation with setting responsibilities and after approval, and plan the implementation without delays.