Digex Co. team studied and analyzed all the details. After that, our team decided to create a complex IT solution.Components used:
Depending on processes, IT system was divided into 3 components:
- Customized Microsoft Project Server.
- Porting to Microsoft Project Online.
- Power BI with max possible version under corporate licensing.
- Storage of documents and regulation of access rights.
- Submission of documents.
There are 3 separate systems for 3 processes. As part of the project, they were integrated using a single API.Planning
This module helps to plan work at portfolio level. Here, a single detailed plan for submitting and processing drug-related documents is created. According to regulators' requirements, any pharma employees have access to planning module without being bound to GMP/GxP licensing.
The module has continuous tracking. The system warns when certain documents should appear and be submitted. Customer’s specialized departments responsible for documentation start each day by checking current drug-related processes.
Links to documents are stored inside each application. The customer’s supervisor checks availability and correctness of all documents. After that, it is possible to change documents status. The supervisor is responsible for plan actuality, compliance with applicable laws and industry requirements. After checking readiness of all documents, they are set into issue mode for posting.
After clicking the submit button, drug-related work plan becomes available to the next specialist in his personal account. After re-checking by an industry expert, there are two options. The system sends documents via built-in integrations with state industry regulators software or instructs special departments to send them manually to pharma industry regulators. There is online tracking. Information on the acceptance status of each document is collected.Document storage and distribution of access rights
The system supports document storage versioning. Each file and document has properties according to the GxP classifier: role model, specific data retention period, and so on. In total, more than 30 types of metadata are considered.Submission of documents
Each document has its own access level. For example, planning the submission of documents doesn’t require GMP/GxP licensing. But the document submission process requires only employees with a valid GMP/GxP license.
For this reason, certified people are engaged in storing and adding documents to the repository. Thus, the document storage subsystem is separated from the planning system. Planning system can be used by all customer’s employees. And only GxP certified specialists can handle documents in storage.
These specialists must meet different criteria. For example, to know the language of the region or country where the drug is certified. Besides, certified customer’s employees must live there. In many countries pharma regulators prohibit remote submission of documents.