ERA Sciences: Life Sciences Expertise in GMP, 21 CFR Part 11, GAMP5, and Veeva Solutions

Our Experience

At ERA Sciences, we bring extensive expertise across the life sciences, pharmaceutical, and medical devices sectors, providing a broad range of services designed to support regulatory compliance and operational excellence. Our team specializes in GMP, 21 CFR Part 11, Annex 11 and GAMP5 standards, ensuring that our clients meet industry-specific requirements for data integrity, quality risk management, and computer system validation.

We are particularly adept at addressing data integrity challenges through data integrity audits, data integrity assessments, and data flow mapping. Our experience in 21 CFR Part 11, Annex 11 and ALCOA Plus compliance has helped numerous clients achieve successful 483 remediation and long-term data governance strategies.

We have supported clinical trial management systems (CTMS) with platforms like Veeva, enabling seamless regulatory documentation and trial oversight. Our work with CDMOs ensures that third-party manufacturers meet GxP standards and comply with FDA, EUDRA and regulatory agency guidelines.

Our capabilities also extend to managing large-scale systems like Rockwell Automation, Waters Empower, and Labware LIMS. Whether it’s implementing LIMS system software for laboratory operations or ensuring end-to-end traceability with TraceLink, we help clients streamline processes and improve data management across their operations.

With deep experience in life sciences managed services, our team supports clients with compliance tools like ComplianceWire and enables the successful deployment of technologies that drive efficiency and regulatory adherence. Our experience spans on-premise, enterprise, and cloud solutions, so whether you're managing local servers, vast enterprise systems, or scalable cloud services, we can offer tailored support.

At ERA Sciences, we help businesses thrive in the evolving regulatory landscape through risk-based methodologies, offering robust quality risk management solutions tailored to meet the stringent demands of the life sciences industry.

Data Integrity

Ensuring data integrity is essential for compliant and reliable operations in the life sciences sector. Expertise in GMP, 21 CFR Part 11, Annex 11, GAMP5, and ALCOA Plus principles ensures your data lifecycle is managed effectively. Data integrity training equips teams with best practices, fostering a culture of transparency and engagement. Through risk-based approaches and data flow mapping, help reduce duplication, apply ALCOA principles, and ensure the right data is available at the right time for your GxP processes.

Risk management

Risk Management is at the core of modern quality methodologies and effective risk management is essential for putting patients first, reducing non-value-added activities and focusing efforts where they matter most. Through a proven methodology, organizations in the life sciences sector can benefit from integrating quality risk management (QRM) into their processes. First-class risk facilitation and comprehensive training ensure that critical thinking is consistently applied, reducing exposure to risks and improving overall outcomes.

ICH Q9 R1, which emphasizes enhanced risk management principles, is a key guideline in this area. ERA Sciences has contributed to the official ICH Q9 R1 training pack, specifically focusing on the topic of subjectivity in risk assessment. This expertise ensures that organizations adopt best practices for managing bias, driving more accurate and consistent results. Maximize success by enhancing your QRM approach today.

Application lifecycle management

Effective management of GxP applications throughout the data lifecycle is crucial for ensuring data security, quality, and empowering teams. Leveraging best practices in GAMP5, ALCOA Plus, and CSV (Computer System Validation) helps organizations streamline implementations for enterprise systems like Veeva. The adoption of the new modern methodology of Computer Systems Assurance (CSA) enables a risk-based approach, focusing on critical areas and reducing unnecessary documentation. This approach ensures compliance while enhancing system efficiency. Workshops, training, and change management strategies ensure smooth transitions from legacy systems to modern SaaS solutions while maintaining compliance with GMP standards. Alignment with industry guidelines, such as ISPE, further supports organizational success in application lifecycle management.

Stakeholder engagement

An effective stakeholder engagement approach is key to achieving successful project outcomes in the life sciences sector. Aligning teams through structured workshops ensures that all stakeholders, including subject matter experts, are fully engaged and aligned, reducing risk subjectivity and addressing potential biases. Utilizing tools like the RACI matrix enables clear roles and responsibilities, fostering collaboration and accountability. A risk-based approach is applied to focus efforts where they matter most, enhancing decision-making with frameworks like GAMP5 and ALCOA Plus. By leveraging proven methodologies, organizations can drive better results and minimize non-value-added activities, leading to successful GMP project outcomes.