READY! for ePI
READY! for ePI is a digital ecosystem that enables pharmaceutical companies to manage this huge task on-time by using our state-of-the-art IT technology with the help of Artificial Intelligence (AI).
READY! for ePI
Our solution enables the industry and the regulators to create and manage ePI using our DiCE XML Editor.
For the purpose of handling ePI (electronic Product Information), we have pre-configured our READY! platform to meet the specific demands of recognition, import, indexing, authoring, quality check, lifecycle management, and submissions of ePI documents in XML format.
The use of Artificial Intelligence makes the process faster and improves the accuracy of the migrated documents.
READY! for ePI comprises:
DiCE XML Editor
DiCE XML Editor is an XML editor specifically configured to easily create and edit ePI and SPL documents.
Our DiCE XML Editor is the result of our more than 20 years of experience with handling of structured documents. It perfectly integrated with READY! – which facilitates the importing and workflow of ePI documents in a validated environment.
The specific implementation of DiCE is designed to meet the requirements of subject matter experts to quickly author ePI and SPL documents. These ePI documents are based on QRD templates that are pre-structured and pre-filled, and the authors can only edit where the template allows them.
DiCE XML Editor is fully functional document editing tool with the following functionality:
• Document templates for ePI,
• Write text, content,
• Text formatting,
• Multilingual support (Unicode),
• Support for electronic structure of ePI,
• Support for granularity and coded information elements of ePI,
• Support for headings and sections of ePI,
• Compare text – delta,
• Compare versions,
• Track changes,
• Sections parallel authoring & approval,
• Headers/footers,
• Comments,
• Copy-paste text,
• Copy-paste from MS Word,
• Copy-paste from PDF,
• Drag-Drop,
• Find&Replace,
• Translations support,
• Tables support,
• Formulas support,
• Hyperlinks,
• Crosslinks,
• Header/footers,
• Reuse of content across documents, and
• Automatic population of documents with IDMP metadata based on SPOR.
There are several issues related to the conversion of unstructured documents (.doc or .rtf) into structured xml format:
• Defined structure with headings/sub-headings (style sheet),
• Consistent creation of bullets/numbering, and
• Defined formats for tables, figures, graphic symbols, footnotes, and frames/boxes.
DiCE = Documents with intelligent ContEnt
READY! – A Product Lifecycle and Document Management System
For the purpose of handling ePI, we have pre-configured our READY! platform to meet the specific demands of recognition, import, indexing, authoring, quality check, lifecycle management, and submissions of ePI documents in XML format. The use of Artificial Intelligence makes the process faster and improves the accuracy of the migrated documents.
The solution enables large and medium-sized companies to start with the preparation and migration activities.
READY! configuration for ePI enables:
• OCR integration, batch import, indexing, clean-up of SmPCs and PILs,
• Document bulk import,
• Document recognition and indexing using AI,
• Modular structure support,
• Structured templates support,
• Document quality control workflow,
• Document approval process workflow,
• Versioning control,
• Track changes,
• Adding comments,
• Document indexing,
• Access control,
• Role-based security,
• Management of ePI in XML format,
• Management of PI in Word format,
• ePI specific roles can be assigned to service providers such as translators,
• Document search,
• Automatic renditions to PDF and Word,
• Management of PI in Word format,
• Safe Digital archive,
• Automated comparison of old vs new text/tracking of changes, conducted in the back end,
• Track changes or text comparison,
• Integration with IDMP product lifecycle management,
• Integration with RIMS systems,
• Interoperability with other IT systems,
• Full support for IDMP&SPOR data, and
• Full document management functionality.
ePI Document Templates
The handling of PI documents is a complex process. Even without support for ePI the whole process involves various parties in the process.
Our preconfigured process templates are based on QRD templates and are designed to manage Labelling, and PI documents cover the complete management of document in all phases of the lifecycle.
Artificial Intelligence services
We are integrating Artificial Intelligence services for automatic document recognition, identification, data extraction, indexing, and quality control of PI documents.
PI information in existing documents can be extracted into machine-readable format using Artificial Intelligence (AI) muck quicker and with fewer errors.
Three methods can be used to extract text from documents:
Manual text entry
Authors read documents and then manually enter the text they see into a system. This method requires a significant time investment and is prone to mistakes.
Semi-automated solutions
Applications parse documents that have a fixed layout and then extract the text using optical recognition or OCR technology. This method can be effective, but it’s limited in the types of documents that can be processed. Each PI document is very complex and cannot be processed fully using such traditional approaches.
Artificial intelligence (AI) and machine learning
We use Artificial Intelligence (AI) and machine learning to analyse PI documents and extract information. This helps remove much of the data entry toil and can reduce document processing time. The AI technology has progressed rapidly in the last few years, and it’s now possible to use it to read documents, parse the content and extract value.
Information is being extracted from many different documents and is combined and compared with other sources of information such as publicly available information about medicines.
Understanding documents is an incredibly complex field in machine learning because it combines a lot of different techniques and algorithms – for example OCR image recognition, natural language processing, entity extraction, machine translation, and data loss prevention just to name a few.
And this is where document AI comes in to turn unstructured content into structured ePI documents based on QRD templates.
AI not only reads and adjusts your documents, but it also understands the spatial structure of the document.
For example, the PI document is parsed into sections that later can be edited in the DiCE editor. The sections are defined by the QRD templates.
READY! ePI FHIR Gateway
The READY! ePI FHIR Gateway enables the actual submission of the ePI in XML format to the EMA.
Everybody is wondering what this will look like and when the EMA is going to enable the upload of the ePI.
While this looks now as the most complicated part of the whole story, it is in fact the smallest problem the industry is facing now.
The FHIR standard is well-defined, and it is easy to implement the gateway to implement the automatic upload of the ePI documents as soon as the EMA makes this feasible.
The real problem the industry is facing now is how to find, collect, and analyse existing PI documents and where to store them. The second phase is to rewrite the documents using new XML tools. Once the documents are created in the new format, the industry will have to maintain the lifecycle and approval process of electronic documents in validated environment.
The submission via the Gateway using FHIR standard will happen only when these steps are finalised.
The EMA will make the authoring tool for ePI available via the PLM portal for everybody.
This solution is perhaps favourable for small companies, however, this is not a solution for medium-sized and large companies handling vast amounts of documents.
We will enable submissions in the FHIR format as soon as the EMA makes this functionality available.
EMA ePI Authoring tool
The EMA will make an authoring tool available that will help small companies to create their ePI information online. However, this is not a solution for large and medium-sized companies. For this purpose we have developed our own XML editor – DiCE.
What is the challenge for large and medium-sized companies?
The problem the industry faces first is how to find, collect, and analyse existing PI documents and where to store this information.
The industry will have to collect, analyse, create, and check millions of PI documents in many languages. Most of these final and approved versions of documents are currently in paper or scanned PDF and image formats.
The second problem is to rewrite all of the documents using new XML tools. Traditional document authoring tools such as Microsoft Word will be obsolete.
Finally, the industry will have to maintain the lifecycle and approval process of these electronic documents in a validated environment.
Approved and effective PI documents in ePI format will have to be uploaded to the EMA using the FHIR gateway, a new technology.
After the upload, the maintenance of the documents including new version will have to be facilitated, like the management of Article 57 data.
Why should you care?
To prepare, submit, and maintain documents in ePI, the industry will have to:
- Identify and collect approved and effective versions of existing valid PI documents,
- Transform existing valid documents into new XML format using new tools,
- Create new documents in XML using new tools,
- Check all documents and their translations,
- Submit documents to the authorities using new IT technology,
- Keep track of regulatory status of the documents,
- Keep record of the documents in electronic format,
- Maintain changes and new versions of the documents,
- Manage lifecycle of the documents in electronic format,
- Track approved and effective status of ePI documents,
- Keep links between translations of same documents,
- Link documents to the related medicinal products,
- Reuse documents in other systems (integrations), and
- Integrate documents with digital sources in IDMP/SPOR format.
READY! SOLUTIONS
Follow a manual added link
READY! for ePI
Prepare, submit, and maintain documents in ePI with our pre-configured READY! platform.
Follow a manual added link
Product information, Labelling
Increase efficiency in the approval of PI during regulatory procedures.
Follow a manual added link
Regulatory Affairs
Replace Excel spreadsheets, shared drives, and outdated regulatory databases.
Follow a manual added link
Article 57 reporting gateway
Exchange medicinal product information with a click on one button.
Follow a manual added link
Pharmacovigilance
Promote, maintain, and improve compliance with the legal requirements.
Follow a manual added link
Development
Track milestones and store documents created in the development of a new medicine.
Follow a manual added link
Quality Assurance
Manage processes, documents, and products in one integrated platform.
Follow a manual added link
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.
