It is increasingly diffcult for the pharmaceutical and biotechnology industries to guarantee regulatory compliance at all times. Many aspects of the development, manufacturing, marketing, distribution, and administration of pharmaceuticals and biotechnology products are subject to strict regulations. With high volumes of data being digitized, there is a distinct need to both protect and manage this information centrally and adapt and issue it to multiple domains, such as healthcare providers or consumers. If a company does not have a system in place for traceability, it will be unable to meet these strict requirements, which is especially important today with so many counterfeit drugs on the market. Failure to meet these obligations may lead to potential risks to patient safety and could result in severe financial penalties and sanctions.
All of this and more can be managed centrally with Viamedici multi-domain MDM
1
Pharmaceutical and biotechnology manufacturing companies have vast amounts of data and product information. They need to keep a detailed record for each medication, from the development and manufacturing stages through to marketing, packaging, distribution, and patient administration. Understanding who the end consumers are is vital in the event of product recalls.
With Viamedici MDM and PIM, all product information is managed centrally – product descriptions, specifications, images used on the packaging, tracing of ingredients, and capturing data on which patients are using the medications. By monitoring patient usage, healthcare providers can assess if the drugs are being used in line with prescriptions, and manufacturers can react swiftly in case a product needs to be recalled.
2
Healthcare providers, such as hospitals, nursing homes, or outpatient care centers need to maintain a complete record of interaction for each patient that enters their facility.
We support patient lifecycle management by providing a full overview of the patient, from the moment they arrive at a facility through to the medication administered, any operational procedures, details of when they are discharged, and what happens to them after leaving the facility. All this information is managed in MDM.
3
The growing number of counterfeit medications is a major health threat to patients, therefore traceability within the supply chain and network of partners is key to proving compliance.
Our solutions enable full traceability for each drug and the ingredients that are used. By creating a golden record, medications are labeled consistently and in line with the legislation in the respective markets.
4
Pharmaceutical and biotechnology manufacturers and healthcare providers have to share a lot of diverse information with multiple stakeholders and partners. Different levels of content need to be managed for different parties. Therefore, they need to make sure that the information they are sharing is accurate, up to date, and relevant to the recipient.
Viamedici multi-domain MDM and PIM enable companies to create a single source of truth. Companies can collaborate seamlessly with partners and strengthen relationships by giving them access to the latest, relevant information in real time. This speeds up processes, whether in the manufacturing of new medications or their administration by healthcare providers.
5
Due to increasing threats of data breaches, regulatory bodies such as HIPAA and the FDA have imposed ever-increasing regulations with regard to protecting digital data. In light of limitations regarding what information can be shared and with whom, regulatory compliance and careful management of data are imperative.
Viamedici multi-domain MDM incorporates cutting-edge, robust security technology to protect sensitive information, such as patient data and trade secrets. Through central management and roles-based access, only authorized people have access to confidential information.
Case Study
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