The life science industry is one of the most highly regulated in the world. While certain compliance requirements in pharma can seem like a headache, these regulations are put in place in the interest of public health and data security – and to ensure that the drug development process is as safe, effective, and ethical as possible. In this article, we discuss the importance of pharma compliance software, explore some available pharma compliance solutions, and consider insights management technology’s role.
“No other means ensure the wellbeing and health of people than regulatory compliance.” – GCP Learning
Compliance and the pharma industry
Every country has its own set of pharma industry compliance laws and regulations. Any pharmaceutical company that deals in a particular country – no matter where that company is based or where drugs are manufactured – will be bound by that country’s regulatory requirements. Navigating this tangled regulatory thicket can be enormously complex – potentially leading to mistakes that can result in noncompliance.
In the United States, regulatory bodies such as the FDA regulate processes including:
- Clinical trials
- Manufacturing practices
- Product approvals
- Risk management
- Data management and security
- Advertising and promotion
There are also international laws and regulations – such as the EU’s General Data Protection Regulation (GDPR) in Europe, which applies to any company that handles the personal information of EU data subjects whether that company is based in the EU or not.
Failure to comply with these regulations and others like them can result in significant censure from regulatory bodies and government agencies.
“Loss of manufacturing capability as a result of regulatory non-compliance can have a devastating impact on biopharma or medical device manufacturers, and can happen anywhere along a company’s supply chain.” – European Pharmaceutical Review
Pharma companies can expect to pay a heavy penalty for non-compliance. Failure to comply with GDPR regulations, for example, can result in a fine of up to €20 million or 4% of a company’s total global turnover – whichever figure is higher. But ensuring regulatory compliance is about more than simply avoiding penalties, however. By complying with these regulations, pharma companies can ensure that the drug development process is safe, effective, and repeatable, that patient and customer data remains secure, that products are fit for purpose, and that companies are safe from liability. Pharma industry compliance software has a role in helping firms achieve and maintain compliance.
The different types of compliance software
Many pharma industry compliance solutions are available, each designed for a different area or application. These solutions allow life science teams to automate manual processes – saving time, improving accuracy, and helping to avoid potentially costly errors. Pharmaceutical Technology states, “Digital technologies can help to skillfully manage extensive amounts of data and promote value addition to the company by streamlining compliance operations, helping companies prevent wrong, unforeseen situations.”
- Pharmaceutical regulatory compliance software provides a single source of truth for content creation and approval to improve workflows, enhance collaboration, and accelerate approval cycles.
- Serialization software assigns a unique serial number to each new drug or pharma product, allowing companies to track and trace these products across the supply chain.
- Supply chain visibility software brings transparency to supply chain processes, allowing pharma companies to track the status of products and shipments.
- Integrated monitoring software uses ‘internet of things’ technology to remotely monitor critical assets across the supply chain, helping to ensure the quality, safety, and timely delivery of pharma products.
- Customer engagement solutions allow pharma teams to more effectively manage their field force and sales strategies, ensuring compliance with pharma industry advertising standards.
- Brand protection software monitors bad actors attempting to sell counterfeit products, infringe on a pharma company’s intellectual property, or create fraudulent listings under their brand.
Insights management platforms and compliance
Insights management technologies – such as the Within3 insights management platform – represent another option to support pharma industry compliance efforts. Asynchronous virtual engagement offers a secure, compliant platform for stakeholder and HCP engagement – helping compliance committees and medical affairs compliance teams conduct activities like virtual advisory boards that comply with industry regulations while handling sensitive personal information and other valuable data.
“Investing in compliance and quality has traditionally demonstrated a strong return on investment for organizations.” – PharmExec
Applying an organization-wide virtual engagement strategy allows pharma teams to standardize the insights-gathering process – making it reliable, repeatable, and predictable. Commercial teams, meanwhile, can employ an insights management platform for patient engagement activities – anonymizing engagement sessions to ensure privacy and anonymity.
Whether you opt for traditional pharma industry compliance software, adopt an insights management platform or consider a combination of the two, regulatory affairs in pharma remains a high priority in the industry. Read more about compliance in the pharmaceutical industry.