Customer Story: Globalpharma
Globalpharma is a wholly owned subsidiary of Dubai Investments PJSC. It started its UAE operations in 2003 and is registered in GCC countries, including Qatar, Kuwait, Oman, Bahrain, KSA, and UAE, as well as other export markets such as Iraq, Sudan, Lebanon, and Jordan.
A market leader in key generic pharma segments, Globalpharma manufactures and distributes over 95+ generic pharmaceutical products in almost all lifestyle disease segments, including cardiovascular, anti-ulcerants, anti-diabetics, anti-arthritis, analgesics including NSAIDs (nonsteroidal anti-inflammatory drugs), respiratory, antihistamine formulations, anti-infectives, and multivitamin supplements.
The company constantly focuses on continuously expanding its portfolio of covered therapeutic areas, launching new products to meet the “unmet needs” of the patient.
Eliminating Spreadsheets in Regulatory Management
The Regulatory Affairs team at Global Pharma followed traditional and manual methods to manage registration documents and data, including storing documents in shared folders. All data were tracked in Excel spreadsheets. With many people using spreadsheets, there were data entry errors and missing data. There were trials to have only one person in charge of the spreadsheets, but there was no system to manage all the data.
Reem Khayal is Globalpharma’s senior manager of regulatory affairs. She handles registration for UAE and KSA and is responsible for a team that manages registrations in other markets.
The department head was looking for a solution to facilitate Reem and her team’s work. They wanted a regulatory management system (RMS) to help them manage the registration information and the registration process. The RMS had to be a user-friendly solution that maintained the company’s product history and enabled them to produce reports quickly when management asked for specific information.
Solutions were shortlisted to two potential options, one of which was Scigeniq. While at a GCC conference, Reem and the department head viewed and liked a demo of Scigeniq RMS. They requested another meeting with Scigeniq to learn more about the company and the product and decided to go with Scigeniq in August 2023.
The first step was migrating the data from the Excel spreadsheets, followed by migrating the files a few months later. The RMS went live in May 2024 and has five users, including Khayal.
Khayal said that the reporting feature was one of her favorite features.
“If I want to know what inquiries are still pending, I can just click a button, and it sends it [the report] to my email within minutes.”
Automating Document Processes
Before implementing an electronic document management system (DMS), the quality team at Globalpharma managed its documentation manually. They had SOPs in place for the work they needed to do and used an Excel spreadsheet to track tasks in the process. In addition, they printed hard copies of documents that needed to be signed.
For their batch process, they implemented e-signatures on the Microsoft Word level.
According to Karunanithi Veerapandian, Assistant Manager Quality Assurance, there were two primary reasons for the decision to implement a DMS:
- They wanted to automate their processes.
- They wanted to bring everything into a centralized platform.
Using the company’s software procurement process, the Quality team selected multiple vendors, conducted a technical review, and viewed a demo.
The Scigeniq DMS provided features that would help them automate their processes without requiring changes to the existing process. It was also easy to use.
There were two important features that needed to be addressed before moving forward with the DMS. First, Globalpharma wanted the DMS to autogenerate batch numbers, but this is typically done by an ERP system. Scigeniq supported the company to set up batch number generation in ERP system. Then, Scigeniq created an integration between SAP and the DMS, where the DMS requested the batch number from SAP and also pulled in full batch information.
The second is related to printing templates. Globalpharma had many printing templates to implement in the DMS with specific headers, footers, and cover page information. They also requested that a printing counter and type of copy be added to the templates. In addition, Scigeniq added enhanced printing options, including multi-copy print, printing page ranges, and creating a printing distribution list.
The Quality team had around 2,000 documents to migrate to Scigeniq DMS, and they successfully did so with the help of Scigeniq’s support team.
From the decision to go with Scigeniq DMS to implementation, it took 5-6 months. Today, 40+ people use the DMS daily.
Working with a Supportive, Experienced Team
As Globalpharma implemented both the DMS and the RMS, the Scigeniq support team was there every step of the way, listening to their needs and helping to resolve challenges.
Geeta Gujaran, Site Head, said that what stood out to them about Scigeniq was its expert team.
“Scigeniq has huge pharma experience with some big pharmaceutical companies in the region. That was very important to us.”
Khayal agreed, noting that the Scigeniq team was very supportive and helped her team solve tickets quickly.
Bencymon Varghese, Quality Assurance Manager, said another critical consideration for Globalpharma was to find a technology partner who would work with them in a true partnership. The Scigeniq team was open to suggestions for new features and functionality for both the DMS and RMS.
Future plans include integrating the RMS and DMS and enabling other teams in the supply chain to access certain information in the RMS to eliminate email requests.
