Simplified Document Management for the Life Science industry
Our document management and business process automation system BIP 365, grew from solutions required within the Life Science industry, where the drug-to-market steps are critical and thoroughly regulated.
From Pre-clinical to Production, BIP 365 can help companies manage their digital documents/files and increase their productivity.
— Drug-to-market —>
How can BIP 365 empower users through these steps?
By applying applicable feature packs
Applicable through all steps
Department Documents
A basic document structure for any pharma company with departments and common document templates.
Business Process Management
Helps everyone in your business understand how important business processes work. Aids in developing more efficient processes and shares the knowledge across your organisation.
Advanced Search & Reporting
Advanced searching with content indexing is available across all feature packs. Advanced Business Intelligence reporting is also available out-of-the-box.
Project Management Office
Standard document structure for project management for your PMO.
eTMF
(step 1 & 2)
Clinical site management with electronic Trial Master File standard, includes pharma and Clinical Research Organisation functionality.
Specific steps
SUSARs
(step 1 & 2)
Communicate and track distributed documents in adverse events adapted for SUSARs as well as DILs.
Promotional material
(step 2 & 3)
A basic structure and templates for Promotional and Non-promotional materials.
Regulatory
( step 3)
DIA submission reference model adapted with templates for submitting eCTD or CTDs in EU, US,CA, GCC,CH,AU,JP, ROW. Specific to DIA or simplified with dossiers and sequences.
Quality Management System
( step 4 & 5)
Quality Management System and quality assurance in one. Corrective and Preventive Actions, Deviations and change controls for equipment and systems.
Medical devices
( step 3)
Medical device submission following model 10 template.
Application Lifecycle Management
(steg 4 & 5)
Manages all the applications implementations with Validation and Qualification for IQ and OQPQ etc. Following the V-model. This can also be used for any Validation or Qualification, not only for applications.
Batch records
( step 4 & 5)
Master batch records and batch records management and numbering.
One system for all types of users
At the same time as a document management system should simplify document & business process management, guarantee secure collaborations between internal and external parties and be able to expand together with your company, it should also be user-friendly. A well-thought-out system saves the company both time and money when it comes to trainings and IT-support.
That’s why BIP 365 contains user-friendly functionality such as:
Virtual libraries consisting of a collection of documents, images, videos, or presentations that users need quick access to. For example, all contracts for a specific customer, or all documents for a specific project.
Landing pages that customize the content depending on the user's level of access.
One and the same user experience regardless of which device they are using (desktop, tablet or mobile).
... and much more!
See for yourself how users can easily navigate and work in BIP365!
We’re with you all the way
We’ve made it as simple as possible for anyone to implement and start using BIP 365. The implementation itself takes no more than 30 minutes (!) and can be done by anyone at your IT-department. We provide full documentation and test scripts in order to establish a stable and secure implementation.
We of course provide additional off-site support to help you:
Implement and setup BIP 365 according to your preferences
Structure you data in preparation for future audits by investors, partners, suppliers or government agencies
Integrate existing business software
Automate processes and generate BI-reports utilizing AI
Migrate documents to/from existing storage