Regulatory Compliance and Validation with Aplos NCA

Ensuring regulatory compliance and proper validation of your software is essential when conducting pharmacokinetic (PK) analysis. These are required for studies conducted under good laboratory practice (GLP) and good clinical practice (GCP) standards, and are required for most studies submitted to agencies such as the FDA, PMDA, and MHRA. Aplos NCA is designed to meet these stringent requirements for any analysis, making it a trusted solution for many in the pharmaceutical and biotech industries.

Validation of Aplos NCA

When it comes to validating Aplos NCA, we make it easy to ensure that the software performs as intended for PK parameter calculation. While every organization may have its own unique validation process, Aplos NCA provides the tools necessary to complete a computer system validation efficiently. Aplos NCA validates its PK parameter calculations internally with every release, ensuring that its software continuously meets performance expectations. In addition, it offers ready-to-use validation scripts for all users. Using these scripts any user can verify the accuracy of Aplos NCA PK parameter calculations.

One of the standout features of Aplos NCA is its simple validation command, which executes six separate analyses on public datasets. By comparing the calculated results with known values, users can verify the accuracy of the Aplos NCA system. Each validation will generate a report with a pass or fail status that can serve as evidence of Aplos NCA's performance. This report can be included in your computer system validation documentation to confirm the accuracy and reliability of your PK analysis. All validation executions and reports are retained in the user account and can be retrieved at any time by the user. This helps regulatory and third party auditors confirm that your software is compliant and validated.

The best part? This validation process can be executed at any time, takes less than a minute to complete, and is included with your annual subscription, making it a convenient and cost-effective option for maintaining ongoing compliance.

Regulatory Acceptance of Aplos NCA

For companies conducting non-GLP, GLP, or clinical PK analyses, the question of whether regulatory agencies accept Aplos NCA is vital. The answer is YES.

As the FDA's 2022 Population Pharmacokinetics Guidance notes, "The FDA does not recommend or require the use of particular software. The sponsor should report the software used." This flexibility in regulatory requirements means that Aplos NCA, like other software tools, is accepted by the FDA and similar regulatory bodies for PK calculations. Simply put, if you're using Aplos NCA for your pharmacokinetic analyses, you can confidently submit your results in compliance with the standards of these regulatory authorities.

Aplos NCA and 21 CFR Part 11 Compliance

For pharmaceutical companies, electronic records compliance is non-negotiable, and Aplos NCA is 21 CFR Part 11 compliant. This regulation governs the handling of electronic records and signatures, ensuring data integrity and security in the drug development process.

While Aplos NCA does not implement electronic signatures, it employs secure authentication procedures for all API calls. Aplos NCA implements a gated system where the identity of the user is confirmed before any actions are taken, and the actions are performed only after the user has been authenticated and their permissions for the action are confirmed. Aplos NCA also records every request a user makes and the result of that request.

Additionally, Aplos NCA maintains a comprehensive electronic audit trail, logging activities such as:

• User creation and modifications
• Dataset uploads
• Analysis executions
• Validation executions

Each user, dataset, analysis, and result is assigned a unique identifier, and version controls are in place to ensure transparency regarding the files used for each analysis. All electronic records generated by Aplos NCA are human- and machine-readable and can be exported without needing specialized or proprietary software. This level of traceability ensures compliance during both internal audits and regulatory inspections.

Why Choose Aplos NCA for PK Analysis?

Aplos NCA simplifies the execution of non-compartmental PK parameter calculation with a platform that meets global regulatory requirements and standards, has integrated validation tools, and is lightning-fast. Its powerful features bring transparency, accuracy, and efficiency to the complex process of regulatory submissions, making compliance simpler and more reliable for your organization.

Interested in learning more about how Aplos can help you? Contact us today to discover how we can support your goals!