The pharmaceutical industry is one of the most heavily regulated sectors in the world, with a complex web of constantly evolving rules and requirements that companies must navigate to maintain compliance. From research and development to manufacturing, distribution, sales and marketing, pharma companies face unique compliance challenges at every stage of the product lifecycle.
Non-compliance can lead to severe consequences – hefty fines, product recalls, loss of licenses, reputational damage, and in extreme cases, criminal charges against executives. According to a recent study, the global pharmaceutical industry incurs an estimated $30 billion in compliance costs annually. That’s why having a robust Enterprise Resource Planning (ERP) system with advanced compliance tools has become a necessity rather than a luxury for pharma companies looking to streamline operations, mitigate risks and ensure audit readiness.
Key Compliance Challenges Faced by Pharma Companies
Before diving into how NetSuite helps pharma companies overcome compliance challenges, let’s take a closer look at some of the most pressing regulatory requirements and pain points:
Good Manufacturing Practices (GMP) Compliance
Pharmaceutical manufacturing is subject to stringent current Good Manufacturing Practices (cGMP) regulations enforced by the FDA in the US, EMA in Europe, and other regulatory bodies worldwide. These guidelines cover all aspects of production – from raw materials and equipment qualifications to standard operating procedures (SOPs) and training.
Pharma manufacturers must establish well-defined processes, maintain detailed electronic records, and be able to quickly retrieve documentation during regulatory inspections to prove GMP compliance. Even a minor deviation from GMPs can lead to serious quality issues, product rejections or plant shutdowns.
Track & Trace Compliance
To combat the growing problem of counterfeit drugs entering the supply chain, various track and trace regulations have been enacted globally, such as the Drug Supply Chain Security Act (DSCSA) in the US and the Falsified Medicines Directive (FMD) in Europe. These laws require pharma companies to electronically track and trace prescription drugs at the unit level as they move through the supply chain.
Serialization (assigning unique identifiers to each saleable unit) and aggregation (building hierarchical relationships between units, cases and pallets) are complex processes that require specialized software integrated with line-level equipment. Pharma companies need to ensure compliance with evolving track & trace requirements to avoid supply disruptions.
Computer System Validation
As pharma companies increasingly rely on computerized systems to automate processes and maintain electronic records, ensuring the integrity and reliability of these systems has become critical. All software, databases, spreadsheets and computer-controlled equipment that may impact product quality or compliance must be validated in accordance with FDA’s 21 CFR Part 11 and EU’s Annex 11 regulations.
Computer System Validation (CSV) is a tedious process that involves documenting user requirements, performing installation and operational qualifications, and maintaining a comprehensive validation package with evidence that the system is fit for its intended use. Pharma companies must also establish strict security controls, audit trails and backup procedures for computerized systems.
Quality Management
Ensuring consistent product quality and patient safety is the ultimate goal of all pharma regulations. Companies must implement a robust Quality Management System (QMS) that spans the entire product lifecycle and complies with international standards like ISO 9001 and ICH Q10.
A pharma QMS typically includes modules for document control, change control, corrective and preventive actions (CAPA), supplier management, training management, deviations, lab investigations, and customer complaints. Streamlining these quality processes and maintaining proper documentation is key to avoiding compliance issues.
Regulatory Reporting & Submissions
Pharma companies are required to submit various types of reports to regulatory agencies within stipulated timelines. These include adverse event reports (AERs) for post-market safety surveillance, periodic safety update reports (PSURs), annual product quality reviews (APQRs), biological license applications (BLAs), and drug registration renewals.
Missing reporting deadlines or submitting inaccurate data can result in warning letters, product withdrawals or even criminal prosecution in extreme cases. Therefore, pharma companies need efficient systems and processes in place to collect, analyze and report regulatory data.
Data Integrity & Security
In recent years, regulators have been increasingly focused on data integrity—the accuracy, completeness, consistency and reliability of data used for compliance purposes. Pharma companies are expected to follow ALCOA+ principles to ensure their GxP records meet regulatory standards.
ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available—the fundamental requirements of data integrity. Companies must implement technical and procedural controls such as audit trails, version control, user access restrictions, data backup and disaster recovery to maintain data integrity.
In addition to data integrity, pharma companies also need to ensure the security and confidentiality of sensitive data related to patients, intellectual property, and business operations. With the increasing adoption of cloud-based systems and remote work, robust cybersecurity measures have become essential for protecting against data breaches and ransomware attacks.
How NetSuite’s Advanced ERP Tools Address Pharma Compliance Needs
Now that we have a good understanding of the complex compliance landscape faced by pharma companies, let’s explore how NetSuite, the world’s leading cloud ERP solution, empowers organizations with advanced tools to streamline and automate compliance:
Built-in Pharma-Specific Functionality
NetSuite offers a comprehensive suite of pre-configured features and modules designed specifically for the pharma industry. Some key capabilities include:
– Lot Traceability & Serialized Inventory: NetSuite’s lot and serial traceability features enable pharma companies to track and trace products from raw materials to finished goods. Lot genealogy, expiration date tracking, and serialized inventory management help maintain compliance with track & trace regulations.
– Quality Management: NetSuite’s built-in quality management module allows pharma companies to automate and streamline quality processes. It includes functionality for non-conformance (NC) reporting, corrective and preventive actions (CAPA), audit management, document control, training management, and supplier qualification—all integrated seamlessly with inventory and manufacturing.
– Wholesaler Sales Compliance: For pharma distributors, NetSuite offers a Wholesaler Sales module that automates compliance checks for DSCSA verification router service (VRS) requests before every sale. It ensures only verified, non-suspect products are shipped and maintains a full audit trail.
– Regulatory Reporting: NetSuite provides pre-built templates and workflows for common pharma regulatory reports such as adverse event reporting (AER), annual product review (APR), and product quality complaints. It also offers an integrated submission portal for electronically filing reports with regulatory agencies.
Electronic Batch Record (EBR) Management
NetSuite’s Advanced Manufacturing module enables pharma companies to configure their manufacturing processes and automatically capture electronic batch records (EBRs) at each step. As operators progress through the batch, all material consumptions, equipment usage, in-process quality checks, and exceptions are recorded electronically in real-time.
The system enforces adherence to the approved master batch record (MBR) and does not allow proceeding without required sign-offs. It also integrates with barcode scanners and manufacturing equipment for automated data capture. Electronic batch records drastically reduce documentation errors, improve traceability, and make batch release reviews much more efficient compared to manual, paper-based processes.
Fully Validatable Cloud Platform
One of the biggest advantages of NetSuite is that it is a fully validatable cloud ERP solution. While some pharma companies are hesitant to adopt cloud systems due to validation concerns, NetSuite has been successfully validated for GxP use by hundreds of life sciences companies.
To make the validation process easier, NetSuite provides pre-built validation document templates, test scripts and trace matrices aligned with GAMP 5 guidelines. NetSuite also follows a well-defined development and change management process, with each new release supported by vendor-supplied documentation and regression testing.
The flexibility of NetSuite’s SuiteCloud platform allows pharma companies to build and validate custom workflows, reports and interfaces without compromising the core system’s validation status. Documented script versioning and release management help streamline change control.
21 CFR Part 11 & Annex 11 Compliance
NetSuite has robust, built-in functionality for complying with FDA’s 21 CFR Part 11 and EU’s Annex 11 regulations on electronic records and signatures. Key features include:
– Audit Trails: NetSuite automatically captures a detailed, time-stamped audit trail of all user actions and record changes. This read-only audit log cannot be disabled or altered by users.
– Data Integrity: All records are stored securely with version control, change reason capture, and backup procedures to ensure data integrity. Automatic system checks prevent critical data from being deleted.
– Access Controls: NetSuite allows granular access controls to be configured based on roles, permissions and IP address. It supports multi-factor authentication and automatic user session timeouts.
– Electronic Signatures: NetSuite’s built-in electronic signature functionality with password re-entry and purpose capture can be enabled for any approval step or custom transaction. It fully meets FDA’s requirements for binding e-signatures to records.
Real-Time Visibility & Analytics
One of the biggest challenges in staying compliant is the lack of real-time visibility into complex pharma operations that span multiple departments, systems and partners. Delays in identifying issues often lead to compliance risks going unnoticed until they spiral out of control.
NetSuite provides unparalleled, real-time visibility into every aspect of the pharma business through its powerful reporting and analytics capabilities. Pre-built dashboards and KPIs allow managers to proactively monitor compliance health across suppliers, manufacturing, inventory, quality and distribution.
The ability to drill down from high-level metrics to individual transactions with a single click makes root cause analysis quick and efficient. NetSuite’s built-in tools allow business users to easily create custom reports, charts and dashboards without relying on IT, making it simple to monitor unique compliance needs.
Advanced capabilities like NetSuite Insights leverage machine learning algorithms to uncover hidden patterns, predict potential issues, and recommend optimal actions. By embedding compliance metrics into day-to-day operations, NetSuite empowers pharma companies to make data-driven decisions.
Automated Compliance Workflows
Many pharma compliance processes are complex, involving multiple steps and handoffs between different teams such as regulatory affairs, quality assurance, manufacturing, and supply chain. Delays and miscommunication during these cross-functional workflows often lead to errors and non-compliance.
NetSuite’s drag-and-drop SuiteFlow tool allows pharma companies to easily automate compliance workflows and ensure proper checks and approvals happen at each stage without fail. For example, a new product change request can automatically be routed to the right regulatory and quality team members for approval before proceeding to implementation.
These automated workflows not only reduce manual errors and delays, but also improve the consistency, traceability and efficiency of compliance processes. Bottlenecks and deviations can be quickly identified for continuous process improvement.
Global Compliance Support
For pharma companies operating in multiple geographies, keeping up with varied country-specific regulations is a massive challenge. Differences in import/export laws, product registrations, safety reporting requirements, and language add complexity.
NetSuite’s powerful multi-subsidiary, multi-currency and multi-language capabilities allow pharma companies to seamlessly manage compliance across global operations. The system supports country-specific tax rules, reporting and e-invoicing requirements out of the box for over 200 countries.
NetSuite also offers pre-built data residency and data sovereignty tools for life sciences companies, making it easier to comply with regulations like GDPR. The platform’s extensibility allows adding custom fields and logic to address unique local requirements.
Seamless Integration Capabilities
Despite the robustness of NetSuite’s native capabilities, pharma companies often rely on various best-of-breed applications for specific functional needs. For example, a quality control lab may use a LIMS (Laboratory Information Management System), a content management application may be needed for controlling SOPs, and a separate system may be used for managing clinical trials.
NetSuite’s open architecture and APIs allow seamless real-time integration with any third-party or custom-built application. Pre-built connectors are available for popular pharma solutions such as TrackWise, MasterControl, Veeva Vault, and more. Integration ensures that data flows seamlessly across systems, reducing manual errors and maintaining a single source of truth for compliance needs.
NetSuite also has a robust partner ecosystem with hundreds of pre-integrated, industry-specific solutions available on the SuiteApp marketplace. These tested and validated extensions help meet niche compliance requirements and reduce implementation time and effort.
Anytime, Anywhere Access
In today’s increasingly globalized and remote work environment, the ability to access compliance data and workflows securely from anywhere, on any device, has become more important than ever.
As a true cloud solution, NetSuite is accessible through any web browser or mobile app, without the need for any special software installation or IT maintenance. This allows pharma companies to extend compliance processes beyond the four walls of the office.
Shop floor operators can record deviations directly from the Manufacturing Execution System. Field sales reps can capture electronic signatures from physicians on iPads. Quality managers can review and approve CAPAs remotely. Executives can monitor compliance metrics on their smartphones. By making it easy to complete compliance tasks in real-time from anywhere, NetSuite helps pharma companies stay audit-ready at all times.
Built-In Security & Compliance
Perhaps the biggest concern pharma companies have about cloud software is security and privacy. NetSuite takes this extremely seriously and has designed its cloud infrastructure from the ground up with security and compliance in mind.
NetSuite’s data centers are ISO 27001 certified and HITRUST CSF certified, meeting the highest standards for physical security, data encryption, network protection, and availability. Regular penetration testing and vulnerability scans are conducted by third-party experts.
All data is encrypted both at rest and in transit using industry-standard protocols. NetSuite offers advanced tools for managing data access, including role-based permissions, field-level encryption, and IP address restrictions. Single sign-on (SSO) and two-factor authentication (2FA) ensure secure access.
In terms of privacy, NetSuite complies with global regulations like GDPR and CCPA. NetSuite’s EU-US Privacy Shield and APEC PRP certifications provide additional safeguards for cross-border data transfers. The company also signs Business Associate Agreements (BAAs) with pharma customers as required under HIPAA regulations.
By leveraging NetSuite’s robust security and compliance infrastructure, pharma companies can confidently build their own GxP applications on top, saving significant time and effort.
Customer Success Stories
NetSuite’s advanced compliance capabilities have been successfully implemented by pharma companies of all sizes across the globe. Here are a few examples of how customers have achieved transformative results:
Epizyme
Epizyme is a clinical-stage biopharmaceutical company focused on developing novel epigenetic therapies for cancer patients. As the company scaled its operations and prepared for commercialization, they needed an ERP system that could handle the unique compliance needs of oncology drug manufacturing.
NetSuite’s Manufacturing module helped Epizyme streamline GMP operations and facilitate FDA compliance. Integrated quality management, lot traceability, and electronic batch record capabilities allowed Epizyme to establish robust processes from the start.
According to Jack Bell, Director of Manufacturing Systems at Epizyme, “NetSuite has been a key factor in our ability to move quickly while maintaining compliance. We can track and trace our products from raw materials to patient administration, all electronically. During inspections, we can easily provide regulators a window into our operations.”
Franvax
Franvax is a global leader in pharmaceutical cold chain logistics, serving clients across Europe and APAC. With over 140 GDPs (Good Distribution Practices) compliant warehouses worldwide, Franvax needed a unified system to standardize and monitor storage, transport, and handling processes for temperature-sensitive pharmaceutical products.
NetSuite helps Franvax comply with EU GDP regulations and ensure medicines reach patients safely and effectively. NetSuite’s multi-subsidiary architecture allows rolling out best practices across different countries while accommodating local variations. Real-time tracking and alerts notify of any temperature excursions, while access controls and audit trails ensure data integrity.
“One of the main reasons we selected NetSuite was its strong compliance functionality, including electronic signatures, detailed audit trails, and validation packages.” says Renaud Janssen, VP of IT at Franvax. “We can now manage our global GDP operations on a single, secure and scalable platform.”
OticPharma
OticPharma is a specialty pharmaceutical company focused on developing novel treatments for ear, nose, and throat (ENT) disorders. When the company received FDA approval for its first product, they needed an ERP system that could handle the complex compliance requirements of controlled substance distribution.
NetSuite’s native serialization and traceability features help OticPharma comply with DSCSA regulations. The system captures product movement data from contract manufacturers to 3PLs to wholesalers
Pharma companies deal with various compliance challenges, including adhering to Good Manufacturing Practices (GMP), ensuring track and trace compliance, validating computer systems, maintaining quality management systems, meeting regulatory reporting deadlines, and ensuring data integrity and security. These are critical to avoid penalties, product recalls, and reputational damage.
NetSuite provides lot traceability and serialized inventory management tools that enable pharma companies to track products from raw materials to finished goods. These features support compliance with regulations like the Drug Supply Chain Security Act (DSCSA) and the Falsified Medicines Directive (FMD), ensuring efficient serialization and aggregation.
Yes, NetSuite’s Advanced Manufacturing module allows pharma companies to configure and manage manufacturing processes with real-time electronic batch records (EBRs). This ensures adherence to master batch records (MBRs), minimizes errors, and simplifies batch release reviews.
Absolutely. NetSuite is fully validatable for GxP use, and it provides pre-built validation templates, test scripts, and documentation. Its adherence to GAMP 5 guidelines simplifies the validation process, ensuring regulatory compliance.
NetSuite has built-in features for audit trails, data integrity, electronic signatures, and granular access controls. These functionalities comply with the electronic records and signatures regulations under 21 CFR Part 11 and Annex 11, ensuring pharma companies meet global standards.
Yes, NetSuite’s SuiteFlow tool allows pharma companies to automate complex compliance workflows. For instance, tasks like regulatory approvals, quality checks, and change management can be streamlined to reduce errors, delays, and compliance risks.
NetSuite supports global compliance with its multi-subsidiary, multi-currency, and multi-language capabilities. It ensures adherence to country-specific tax laws, import/export regulations, and reporting requirements, making it an ideal solution for multinational pharma companies.
NetSuite’s quality management module integrates non-conformance reporting, CAPA, audit management, and supplier qualification processes. This helps ensure consistent product quality, regulatory compliance, and streamlined documentation.
NetSuite provides real-time dashboards, KPIs, and analytics tools that allow pharma companies to monitor compliance metrics across operations. Managers can quickly identify risks, conduct root cause analyses, and implement corrective actions.
NetSuite ensures robust data security with features like multi-factor authentication, encrypted data storage, user access controls, and disaster recovery mechanisms. It also follows ALCOA+ principles for data integrity, making it a secure choice for the pharmaceutical sector.
