Leave a request
More detailed
The Digex Co. website uses Google Analytics and Yandex.Metrica services, which allows us to build the content of pages in accordance with your interests and requests, thereby improving the quality of the content offered to you. The cookies we use allow us to recognize those who visit our site repeatedly. These files also serve to track the traffic patterns of visitors on the site, which helps to improve its usability.
You can learn more about the types and files of cookies that we use in our cookies policy.
Digital transformation of document management for medicine life cycle
Client
Service
Digital transformation of document management for medicine life cycle
International pharma company
Years
2017 – 2020
International biopharma holding headquartered in the USA. One of the global pharma giants. For more than 130 years, the company has been creating and producing drugs and vaccines for prevention and treatment of the most complex diseases. Their vaccines and drugs are intended for oncology, hepatitis C, HIV infections, Ebola fever, and other infections.
Vaccines — one of the key activities of this company. For more than 100 years, the holding has been developing, researching, and supplying vaccines worldwide to prevent diseases. Over the past 30 years, the company has been actively engaged in development and research of ways to fight against chronic hepatitis C. Besides, the company is regularly increasing knowledge on this issue.
Vaccines — one of the key activities of this company. For more than 100 years, the holding has been developing, researching, and supplying vaccines worldwide to prevent diseases. Over the past 30 years, the company has been actively engaged in development and research of ways to fight against chronic hepatitis C. Besides, the company is regularly increasing knowledge on this issue.
About the client
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:
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.
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.
The challenge
Digex Co. team studied and analyzed all the details. After that, our team decided to create a complex IT solution.
Components used:
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.
Components used:
- Customized Microsoft Project Server.
- Porting to Microsoft Project Online.
- Power BI with max possible version under corporate licensing.
- Planning.
- Storage of documents and regulation of access rights.
- Submission of documents.
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.
Work progress
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.
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.
The result
300 000
GB of documents are stored in the system as normal
1 500
experts are engaged in document planning
99%
application uptime
20 000+
employees of the company use the IT solution on a weekly basis
Facts and figures
4
life cycle phases of a medicine are considered when documents are prepared and submitted
3
separate systems work together via a single API
Other cases
We’ll give you an independent view of the task, solution options, roadmap, deadlines and budget
