The Importance of NetSuite Validation for Audit Readiness

Today's dynamic business world has made meeting regulations and compliance needs challenging for corporations in the medical devices, pharmaceuticals, finance, and manufacturing sectors. Programs designed to automate comprehensive functions, such as ERP’s, have NetSuite which enables the tracking and management of finances, supply chains, and compliance for audits. However, for some organizations, simply possessing an ERP system is not enough. The company’s NetSuite is audited for compliance with market standards and regulatory requirements to confirm that it is validated. 

Verification and Validation (V&V) processes for NetSuite, compliance verification and validation, include confirming that the ERP system is working as required while meeting compliance requirements such as FDA 21 CFR Part 11, SOX, HIPAA, and GxP. An accurately validated NetSuite system enables the generation of audit-ready documentation, supports automated compliance, and ensures data integrity through systematic controls. This helps organizations to mitigate or reduce risks, noncompliance issues, and effectively simplify the auditing process. Through robust validation, organizations could avoid regulatory penalties, minimize risks, and enhance audit readiness by enabling effective tracking and detection of compliance issues. 

Understanding NetSuite ERP Validation 

As per regulatory authorities, companies in life sciences, healthcare, and finance require validation of ERP systems to manage electronic records. This records the life cycle of financial transactions, supply chain data, aids in quality control and accessibility during audits. A robust framework is provided to control internal system security, user access, and change management, ensuring external and internal policies are followed.  

With validation, all business operations functions, processes, and system data are aligned with the requirements of the laws and regulations set in place. This is achieved by comprehensive testing, documentation, and risk assessment with incorporated business logic to ensure that NetSuite ERP works accurately and consistently. Validation provides a distinct scope, defines goals, and isolates regulatory systems thereby removing compliance risks and allowing control over organizational efficiency and functioning effectiveness.  

Documentation provides auditors the reference needed to system setups, the recorded configuration of tests, and measures taken for compliance which made the system cohesive to guidelines provided for monitoring and controlling risks. Validation, therefore, is integrated with processes, enhances operational effectiveness, reduces compliance risks, and facilitates readiness for audit at all times. Perpetual supervision makes sure all the legal restrictions are met guiding against constant breaches within a regulated environment. 

The Role of NetSuite Validation in Audit Readiness 

The life sciences industry, relating to pharmaceuticals, biotechnology, and medical devices, is perhaps the most regulated industry. Some of the many US regulatory entities including FDA, European Medicines Agency, and other global health agencies spend significant resources in properly regulating this industry. These regulations leave no stone unturned, providing assurance about product safety, efficacy and quality. This is achieved by establishing detailed documentation standards and implementing robust systems and stringent workflow controls. NetSuite validation is extremely important for the life sciences industry in remaining compliant and audit ready.  

Ensuring Data Integrity, Security, and Traceability 

Data in the life sciences field is priceless, and the integrity of this data must never lie in question. In US, there are multiple agencies, such as the FDA, governing the industry and they have rules to follow like 21 CFR Part 11 which states that every electronic record and signature must have a set of policies to follow making them accurate, secure, and impossible to change.  With NetSuite validation, no matter if it is clinical trial data, batch production records, or supplier invoices, every transaction is guaranteed to be captured and stored for all intents and purposes in a non-editable fashion. 

For example, a biopharmaceutical company facing compliance problems because of uncoordinated record management across various departments was developing unique gene therapies. During an FDA pre-approval inspection, the auditors noted problems in batch records and supplier certification records. Implementing a validated NetSuite ERP systems allowed the company to automatically check data entry, apply user access restrictions, and establish an auditable trail for all system modifications. Consequently, compliance was achieved, regulatory fines were avoided, and FDA approval for a product launch was obtained. 

Audit Trail and Compliance Documentation Support 

Life sciences companies undergoing audits are expected to provide validation reports, risk assessments, and change control records. Companies that do not have a well-structured validation approach will most likely not be able to provide a convincing audit trail. 

For instance, a UK-based manufacturer of medical devices, particularly the implantable type ones, experienced complications in a recent audit concerning the European Medical Device Regulation (MDR). The audit received was very particular and required evidence on how the company developed its NetSuite ERP system, especially with regards to supplier qualification and tracking of materials. The firm used spreadsheets and manual logs before validation, which made obtaining relevant data very challenging. After collaborating with validation specialists, the automation of report generation in compliance with the requirements was integrated with the supplier info and production data. The reports generated were audit-ready with no further information required. This transformed the company by significantly improving audit preparation time and meeting the regulations posed by the MDR.

Reducing Risks of Non-Compliance and Penalties 

Ignoring regulations set in place within the life sciences can lead to draining expenses, removing the product from the shelves, or closing the establishment entirely. A NetSuite validated system effectively resolves these threats by restructuring the processes to adhere to the standards and being compliant with regulations. 

Think about a contract manufacturing organization (CMO) that manages multiple biologic pharmaceutical clients. During a routine FDA audit, an inspector uncovered raw material lot tracking gaps caused by a non-validated inventory management system. With such stringent guidelines on Good Manufacturing Practices (GMP), this gap was a significant compliance risk. After adopting a validated NetSuite system, the CMO was able to implement strict lot control, automate material traceability, and produce electronic batch records compliant with GMP. During the subsequent audits of the company’s facilities, there were no major findings which enhanced the company’s reputation and allowed them to win additional contracts with large pharmaceutical clients. 

For life science companies, being prepared for an audit is not simply a matter of compliance, but rather crucial for positive product outcomes, entry into the market, and even patient safety. With a validated NetSuite ERP, companies achieve systems and processes integrity while their data is protected, compliance documentation is automated, and regulatory risks are minimized, allowing firms to deal confidently in highly complex audits. A biotech startup adopting GMP, a medical device company meeting MDR requirements, or a pharmaceutical firm prepping for an FDA inspection – NetSuite validation brings success in this highly regulated industry. 

Arbour Group’s NetSuite Validation Services 

Arbour Group is a leader in delivering NetSuite ERP validation services and helps clients achieve audit compliance through well-defined strategies. Their comprehensive advice on the applicable regulatory compliances allows clients to fully utilize their ERP systems without the fear of business disruption or regulatory constraints. Arbour Group’s validation services for NetSuite are comprehensive and include GxP compliance, HIPAA, SOX, and international quality compliance. They provide complete solutions for crafting compliance strategies, including conducting compliance tests and managing business risks from the changing business environment. Companies that partner with Arbour Group are provided with validation services which simplify document processes, software testing, and protocol generation. Arbour Group performs system validation and change control, enabling clients to reduce their NetSuite validation expenses while continually providing audited business processes with no interruptions. 

Key Benefits of Validated NetSuite ERP for Businesses 

The implementation of a validated NetSuite ERP system has predefined advantages, such as saving time on audit preparation, automating processes, enhancing efficiency, and reducing compliance risks due to increased security. Moreover, it aids in sustaining business continuity. Validated systems eliminate inefficiencies to enable staff to concentrate on more advanced level cognitive work, thus potentiating productivity and cost savings. In a nutshell, validating NetSuite goes deeper than just audits. It lays out a solid foundation of an ERP aimed at business growth strategies while providing an edge through compliance, risk mitigation, and operational efficiency.

Validating NetSuite guarantees an organization that is streamlined and compliant. Businesses derive value from systematic validation and improved operational effectiveness on top of being audit ready. An organization is prepared for regulations with a validated ERP system. Arbour Group provides expert guidance on meeting reporting compliance for NetSuite validation. NetSuite validation saves an organization time, money, and resources. 

Ensure your business is audit-ready and compliant with confidence. Contact Arbour Group today to learn how our NetSuite validation services can help you reduce risk, streamline audits, and meet regulatory requirements.