How STAEDEAN ERP Solution for Life Sciences Supports Compliance?

Regulatory standards and compliance guidelines in life sciences are responsible for ensuring the highest product quality and, in turn, patient safety. A minor oversight can lead to lasting business consequences, including compliance penalties and reputational damage.

While the repercussions are well understood, meeting the compliance standards is easier said than done, and the ever-changing regulatory guidelines are challenging to keep up with. To overcome these challenges, most leading life sciences companies are moving to technological systems to help them. ERP solutions for life sciences are well-equipped to streamline existing processes, support compliance efforts, and enable innovation that gives you an edge over your competition.

How does STAEDEAN ERP Solutions for Life Sciences Support Compliance Efforts?

Compliance is not a one-time task but an ongoing framework of standards and controls that drive consistent, high-quality outcomes. You can strengthen compliance only when the guidelines are implemented in the company's day-to-day operations. STAEDEAN’s Life Sciences Solution simplifies the process of abiding by the guidelines. Below, we list the key areas in which ERP solutions for life sciences assist you with regulatory compliance and the features of STAEDEAN’s solution that support it.

End-to-end Traceability

Traceability allows organizations to track and locate an entity (e.g., a drum of raw material or a vial of product/drug) at any point in the supply chain while maintaining a complete history of its movement and use. In life sciences, traceability is critical for mitigating risks by enabling rapid issue resolution, ensuring efficient product recall management, and supporting the reproducibility of procedures to maintain consistency and quality. Additionally, traceability helps maintain optimal stock levels, directly impacting cost control and overall operational efficiency. ERP solutions for life sciences enable real-time tracking and tracing by centralizing data and providing complete visibility.

STAEDEAN Life Sciences Solution’s Features for Traceability:

• Full Lot Genealogy and Traceability: View historical information about the lot and track the chain of custody with batch management from receipt to release.

• Batch Tracking: Establish batch and sub-batch identification and tracking along with inheritance and independence.

• Serialization: Enable unique product serialization with Global Location Number (GLN), Global Trade Item Number (GTIN), Serial Number, Lot Information, and expiration date information on serialization labels. Create unique serialization QR codes for products.

• Data Modifications: Determine when and who modified the data and track the data accessed.

• Log Report: Maintain database log report with filters, reason codes, and comments.

• Labeling and Printing: Set up the automatic printing of shipping labels, product labels, and labels for traceability.

Reporting

Regulatory compliance in life sciences requires accurate, auditable records that ensure transparency and traceability across manufacturing and quality processes. ERP solutions for life sciences support compliance reporting by automating data capture, enforcing standardized processes, and maintaining strong data integrity and security.

STAEDEAN Life Sciences Solution’s Features for Reporting:

• Storage and Traceability Records: Maintain full lot genealogy, shipment approvals, disposition code updates by role, and transfer orders. Create storage conditions mismatch reports and storage attributes mismatch reports

• Operation Reports: Create dispensing orders and dispensing transaction reports, production costs and variance reports, calibration and verification reports, and control reports.

• Compliance Reports: Generate FDA 21 CFR Part 11 status reports and maintain a failed signature log and failed signature report.

Data Integrity and Security

Life sciences companies handle sensitive clinical data, such as patient information, drug formulations, research findings, and regulatory submissions, all of which need robust safeguarding. This data is essential not only for company operations but also for maintaining patient trust and complying with industry regulations like GDPR, FDA, SOX, and HIPAA guidelines. Data integrity is also key for companies, as bad, outdated, or duplicate data can result in altered products, delayed approvals, patient safety risks, and increased production costs. Regulatory bodies demand that data be accurate, complete, and consistent throughout the product lifecycle.

Protecting data from unauthorized access, cyberattacks, or internal manhandling is crucial to prevent data breaches, loss, duplication, or tampering. A strong data management system that guarantees data security and integrity is essential to mitigate risks, ensure quality, and comply with standard industry regulations. ERP solutions for life sciences help establish a single source of truth and set up rules-based access control to safeguard the data from unauthorized access. They can enable real-time data monitoring and alerts in case of anomalies or suspicious behavior.

STAEDEAN Life Sciences Solution’s Features for Data Integrity and Security:

• Security Management: Set up a simplified role-based security setup, define security roles, establish segregation of duties, and enable second-person verification.

• Risk and Compliance: Set up an internal risk management system by classifying assets and taking security snapshots.

• Auditing and Monitoring: Ensure detailed audit trail, enable quick security audits, and set up security explorer.

• Insights: Set up an actionable BI dashboard

E-signature and Approval Workflows

E-signatures provide the same level of control over digital records as traditional, paper-based signatures with greater efficiency. In life sciences, where data integrity is governed by ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, and Accurate), e-signatures ensure accountability by requiring user authentication, thereby satisfying the ‘Attributable’ principle. FDA's 21 CFR Part 11 regulation mandates that e-signatures include a detailed audit trail, enabling full traceability of document history and state changes.

ERP solutions in life sciences set up access rules to ensure the authentication and integrity of signatures and prevent unauthorized access, tampering, or fraud.

STAEDEAN Life Sciences Solution’s Features for E-Signature and Approval:

• Digital Approvals: Get full e-signature support for approvals like shipment approval (QP release) and workflow configuration, such as item creation, approvals, and transfer orders.

• Compliance Tracking: Maintain enhanced audit trail and e-signatures for GxP critical fields and tables.

• Process Automation: Review batches and set up approval processes with e-signatures.

Change Management

Even minor adjustments in life sciences manufacturing can introduce variability that impacts product quality and patient safety. Robust change management or change control systems are paramount in monitoring and documenting every slight modification. Good Manufacturing Practices (GMP) mandate change control in life sciences companies to ensure the quality and safety of their products.

Change management requires stakeholder review and meticulous tracking to prevent unnecessary changes that incur costs, cause disruption, and result in unintended consequences. ERP solutions for life sciences can help you configure and enforce workflows for change management, approvals, and audit trails.

STAEDEAN Life Sciences Solution’s Features for Change Management

• Change Management: Change production volume, adjust formulas and processes as needed.

• Change Request Process: Document, validate, and approve change requests.

Quality Management

Maintaining the highest quality standards in life sciences is essential due to the direct impact its products have on patient health and well-being. Regulatory frameworks, such as ISO 13485:2016 and ISO 9001:2015, and guidelines from global regulatory authorities establish stringent benchmarks for Quality Management Systems (QMS).

ERP solutions for life sciences are pivotal in enabling organizations to meet these benchmarks. By defining and implementing structured processes and procedures, ERP systems help companies drive continuous improvement, ensure operational consistency, increase efficiency, and minimize waste. A robust QMS strengthens customer trust, boosts retention, and enhances brand reputation.

STAEDEAN Life Sciences Solution’s Features for Quality Management:

• Quality Assurance: Set up a quality audit process and define nonconformance and deviations.

• Quality Planning: Plan your quality processes by leveraging end-to-end visibility into every aspect of your quality control needs.

• Test Specifications and Results: Generate test sheets that include testing procedures, methods, and batch information. Enter results, calculations, and validation within the same solution.

• Streamlined Approvals: Review and approve workflow for quality orders.

• Quality Reporting: Produce reports and KPIs directly from the ERP system or via integration with Power BI and Excel. Avail new out-of-the-box layouts for Certificates of Analysis for internal use or customers, including sales and shipping information.

Validation

Computer Software Assurance (CSA) in life sciences is a critical aspect outlined by regulatory authorities like FDA 21 CFR Part 11 and EU Annex 11 to ensure computer systems used in life sciences operations consistently meet their intended purpose and are aligned with pre-determined specifications and standards. ERP solutions for life sciences should be validated to enhance data integrity and mitigate risks like potential product recalls and compliance violations. STAEDEAN Life Sciences Validation Toolkit simplifies the validation process in alignment with GAMP 5 Second Edition. By providing detailed documentation and process alignment, the toolkit ensures that businesses are prepared for audits and inspections while remaining focused on their core mission—delivering life-changing innovations.

STAEDEAN Life Sciences Solution’s Components for ERP Validation Toolkit :

• User Requirement Specifications (URS): A documented list of requirements specified by the user that the solution must meet.

• Traceability Matrix (RTM): A mapping of user requirements to test cases, ensuring that each requirement is verified and met.

• Configuration Workbook: A list of configurations to be reviewed and finalized in-scope configuration.

• Environment Deployment Checklist: A list of verification steps to verify that the technical prerequisites are met.

• Statement of Compliance: A pre-filled GAMP supplier postal audit to support the Supplier Assessment process.

• Qualification Protocols: 

• Installation Qualification Protocol (IQP): Test scripts to verify the installation of the system.

• Cloud Qualification Protocol (CQP): Test scripts to verify the deployment of D365 environments.

• Operation Qualification Protocol (OQP): Test scripts to verify if the solution functions as expected.

• Performance Qualification Protocol (PQP): Test scripts to verify if the solution manages GxP processes identified by the customer and returns expected results.

The life sciences sector navigates ever-evolving regulatory requirements, partly driven by the need to keep pace with emerging technologies. As regulations become more stringent, companies need digital solutions to support their compliance efforts, avoid costly penalties, and maintain trust with customers and stakeholders. A strong ERP solution for life sciences must integrate industry-focused features to reduce risks, ensure business continuity, and help boost customer trust.

When undergoing digital transformation, especially with an ERP solution for life sciences, your technology partner is as important as your chosen technology. Our experts have combined in-depth industry knowledge and a thorough understanding of the regulatory environment to develop STAEDEAN Life Sciences Solution specially for pharmaceutical, biotechnology, and clinical supplies industry. Built within Microsoft Dynamics 365 Finance and Supply Chain Management, our AI-enabled, out-of-the-box comprehensive solution is designed to support your compliance efforts and streamline operations. It helps you embed a culture of compliance across your ecosystem, allowing you to stay ahead of regulatory demands and focus on growth and innovation.