Adherence to regulatory and ethical standards is critical in the pharmaceutical industry. Compliance ensures that pharmaceutical products are safe, effective, and in line with industry standards Failure to comply can happen at any point in the pharmaceutical process such as clinical trials, quality checks, supply chain management, etc. Robust systems need to be in place to ensure these lapses can be prevented or addressed proactively. What happens if companies are not compliant? Non-compliance to different guidelines such as those laid by FDA, GMP, and GCP results in both financial and reputational losses. These can include penalties, license cancellations, and loss of trust in the brand. There is a lot at stake – for both the company as well as the consumers. What can pharmaceutical companies do to keep themselves compliant? What role can technology play in this? Let’s take a look.

Gearing up for compliance using technology

There is a lot of time and resource requirement in ensuring compliance. Companies need to accurately keep records up-to-date, ensure quality control standards, align with the clinical trial guidelines, monitor adverse effects, and meet manufacturing standards.

Technology can play a significant role in making this easier for pharmaceutical companies. Digitalization also leads to reduced manual intervention and better cost efficiency. Almost all areas of compliance can be simplified using technology. When processes are defined and there is real-time visibility into operations, it results in quicker identification of compliance issues. This paves way for timely intervention. Moreover, a digital ecosystem results in the accurate and tamper-proof recording of events, resulting in faster and more trusted audit trails. This facilitates the easier grant of regulatory approvals for products in different markets.

Technology can be used in many different areas to stay compliant. 5 key areas of opportunity for application deployment are as follows:

1. 1) Document management: There are a lot of documents that need to be recorded and stored in the pharmaceutical industry. Technology allows for keeping documents aligned, fixing common errors, and making it easier to track and retrieve documents. Keeping clinical trial data, safety reports, and regulatory submissions in an organized way makes it simpler to demonstrate compliance.
2. 2) Warehouse management: A defined technology-based approach enables companies to record and track the entire process from receipt of material to dispatch of the product. This creates a trustworthy audit trail for compliance purposes. Moreover, faster and correct work orders for equipment breakdown can also be streamlined using technology, preventing setbacks or faulty products.
3. 3) Quality management: Technology can track critical parameters and attributes, report unplanned actions or outcomes, and make it easier to maintain the required quality. Applications can track the complete information of a particular product to comply with the Annual Product Quality Review, a regulatory requirement.
4. 4) User management: Pharmaceutical industry deals with data that needs to be protected from unauthorized access. The use of technology in processes allows for access restrictions based on user identification and authorization status, which enhances data security. Moreover, tracking the access requests leads to secure audit trails for compliance purposes.
5. 5) Regulatory management: Regulatory requirements can be quite complex, and guidelines can differ by region. Regulatory management applications provide information on various compliance requirements, thereby making submissions easier. There are also applications that can categorize market complaints by criticality, thereby making them easier to address and report.

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