Patient safety, data integrity, and product quality are of the utmost importance within the Life Sciences industry. Thus, regulatory bodies throughout the globe have introduced, and continue to expand on, regulations on how computerized systems should function with no impact on health. What’s more, as the industry is evolving more and more towards Cloud Computing, with the suppliers providing IaaS, PaaS, SaaS, etc. solutions, the responsibility is now gravitating towards these IT companies to deliver software & hardware that would hold up to the scrutiny of a regulatory audit.
Are you a Regulated Company or a supplier of IT systems, and require support with Compliance & Validation? Contact us today to learn how we can help you ensure regulatory compliance and simplify Life Sciences for your organization.
With more nations and supranational organizations establishing Serialization and Track & Trace regulations, it’s becoming more and more important to establish a robust validation approach that can leverage existing processes and requirements while allowing for a lean risk-based approach.
Amalia Technologies, along with its partners, is able to support your organization from analyzing the regulatory landscape and creating requirements through the Request for Proposal (RFP) process to implementation and testing.
It always starts with understanding the applicable regulations and modeling the required process. At this level, similarities between the new regulation and the existing processes can be identified. From that point onwards, requirements can be drafted, and decisions made on which system is best suited to meet them. From process modeling to drafting requirements and RFP, Amalia Technologies can support you with Subject Matter Experts (SME) well versed in existing and upcoming regulations.
After the systems have been identified and contractual agreements drafted, our Validation Managers can support the SMEs in implementing the functionalities, creating appropriate documentation, and testing. Furthermore, our experts can assist by creating of Work Instructions (WI) and Standard Operating Procedures (SOP) to control the operation of the Track & Trace systems throughout their lifecycle.
Spectroscopy is an essential tool for quality control in many industries, ensuring compliance with regulatory standards and upholding the quality, efficacy, and safety of both manufacturing processes and products. Advanced analytical tools, such as Raman, Near-infrared (NIR), and Fourier Transform Infrared (FTIR) spectroscopy, play a vital role in enhancing pharmaceutical discovery, development, and production. At Amalia Technologies we can support your Process Validation lifecycle to ensure that your manufacturing processes comply with Quality by Design (QbD) and cGMP implementation standards.
Our in-house Spectroscopy specialist and Subject Matter Experts (SMEs) can provide you with tailored training, consultation services or develop a customized solution to meet your specific workflow needs in the life sciences industry. If you need help with process validation within your facilities, contact Amalia Technolgies today.