Every idea of developing any drug comes with paper work. Drug development should take place within the framework of industry regulation. Starting from the very idea, research, and clinical trials and up to production, sale, and production discontinuation. In the USA, pharma regulation is handled by special authorities. GMP/GxP rules regulate this process. Compliance with a large set of these rules differs dietary supplements from drugs.

Compliance with GMP/GxP is monitored by submitting reports. From 1,000 to 15,000 document items are submitted during the implementation of an average project. Usually drug life cycle is up to 50 years. So, submission of drug-related documents has been carried out for decades.

There are only 4 stages of drug’s life:

• Initial stage — concept and theory verification.
• Confirmation of safety for humans.
• Confirmation of effectiveness and performance test.
• Drug production and its subsequent disposal.

At each step, pharma company must properly monitor and organize submission of documents for drug research and development. There is no industrial solution for such automation in the current IT market. There are only IT solutions intended for submitting documents but no systems that plan the entire process within a full cycle covering all 4 stages.

In addition, there is also a problem of drug development scope. If a single drug is developed, it is possible to track and submit documents manually. But large pharma holdings work on hundreds of drugs at once. It is impossible to track and submit documents on time with such scope. Any document not submitted on time and not properly executed stops any drug-related business processes. It may result in huge financial losses.

Digex Co. team studied and analyzed all the details. After that, our team decided to create a complex IT solution.

Components used:

• Customized Microsoft Project Server.
• Porting to Microsoft Project Online.
• Power BI with max possible version under corporate licensing.

Depending on processes, IT system was divided into 3 components:

• Planning.
• 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.

Special solution developed by our team has been put into commercial operation and handed over to the customer. During the first two years, quality of data forecasting has improved significantly. Percentage of inaccuracies and errors in planning, execution, and delivery of required documents has reached 0.1%.

The system is a key business asset for one of the global pharma leaders. Implemented project is included in TOP 3 customer’s recording systems within IT architecture. Prior to system introduction, errors in planning and paper work resulted in 6 or more hours of downtime. The customer was forced to dismiss entire departments for such failures. With complex IT solution to digitalize the data management of drug life cycle, such errors are no longer the cases in the company’s practice.

10 key developers implemented the project. Development team was assisted by the second and third support lines from Europe and the USA. In the second year of operation, the system was used by more than 20,000 customer’s employees. And 1,500+ employees participated in planning. All reports and document databases were updated every 15 minutes. Final repository normally stores more than 300,000 GB of data.