Alcami Corporation has emerged as a trusted partner in the field of development and manufacturing within the pharmaceutical industry. With a focus on oral solid dose product development, Alcami understands the criticality of stability storage, analytical development, and the overall product development lifecycle. In their quest for regulatory compliance, time savings, and cost efficiency, Alcami turned to Tego’s innovative custom AWS RDS automation solution. This blog explores how Tego’s expertise helped Alcami Corporation meet regulatory requirements while saving valuable time and resources.
Streamlining Stability Storage:
Stability storage plays a vital role in ensuring the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. Recognizing the need for a robust stability storage system, Alcami sought a solution that could efficiently handle large volumes of data while maintaining regulatory compliance.
Analytical Development and the Development Lifecycle:
Analytical development is a critical aspect of the pharmaceutical industry, ensuring adherence to rigorous quality standards and regulatory requirements. Alcami Corporation recognized the importance of optimizing their analytical development processes while aligning them with the overall development lifecycle.
Tego’s Custom AWS RDS Automation Solution:
To address Alcami Corporation’s requirements, Tego developed a custom AWS RDS automation solution. Leveraging their expertise and collaboration with the Electronic Lab Notebook (ELN) provider, Tego worked to develop a solution that met Alcami’s corporate standards for data retention. By integrating with the ELN, Tego automated the sharing of RDS snapshots to Alcami’s Tego-managed AWS account and performed backups according to the customer’s policy.
Meeting Regulatory Requirements and Corporate Standards:
Alcami Corporation faced challenges in ensuring regulatory compliance while adhering to their corporate standards for data retention. The native capabilities of the ELN solution they utilized fell short of meeting their requirements. With Tego’s custom AWS RDS automation solution, Alcami successfully bridged the gap between regulatory compliance and their corporate data retention standards.
Efficiency and Cost Savings:
Tego’s automation solution provided Alcami Corporation with significant time and cost savings. By streamlining the backup process and integrating it with their preferred AWS account, Alcami achieved greater efficiency in managing data and complying with their corporate standards. The automated backups and sharing of RDS snapshots reduced manual effort and allowed Alcami to focus on core business activities.
Enhanced Compliance and Data Retention:
Tego’s collaboration with the ELN provider enabled Alcami Corporation to meet regulatory requirements while ensuring the preservation of data according to their corporate standards. The automation of RDS snapshots and backups provided Alcami with a robust and reliable system for compliance and data retention, enhancing their overall regulatory posture.
Conclusion:
In the dynamic world of pharmaceutical development and manufacturing, Alcami Corporation understands the importance of leveraging innovative solutions to meet regulatory requirements while optimizing efficiency. Through Tego’s custom AWS RDS automation solution, Alcami successfully streamlined stability storage, enhanced analytical development, and aligned their development lifecycle with regulatory standards. By collaborating with the ELN provider, Tego developed an automation solution that seamlessly integrated with Alcami’s existing processes, allowing for efficient data backup and retention. This partnership not only helped Alcami meet regulatory requirements but also resulted in significant time and cost savings. Tego’s expertise and automation capabilities solidified Alcami’s position as a trusted leader in the pharmaceutical industry, ready to navigate the challenges of development and manufacturing while maintaining compliance and data integrity.