About Computer System Validation
In today's highly regulated pharmaceutical and healthcare industry, the validation of computer systems is a critical component of ensuring data integrity, patient safety, and regulatory compliance. PinnApt Systems is dedicated to providing comprehensive computer system validation solutions, specifically tailored for ARISg and Oracle Argus. Our team of safety experts possesses the expertise required to customize validation suites, meeting the unique needs of each client, and delivering cost and time-effective solutions.
Our Comprehensive Validation Suites
At PinnApt Systems, we offer complete validation suites for ARISg and Oracle Argus, recognized leaders in pharmacovigilance and drug safety solutions. Our validation services encompass the drafting of validation scripts, related artifacts, and the execution of validation testing in alignment with industry standards such as the Good Automated Manufacturing Practice (GAMP). Our approach ensures the qualification of the end-to-end solution, including the validation of external systems and interfaces used for data exchange.
Key Components of Our Validation Services
Our computer system validation services cover a range of crucial aspects, ensuring that your systems are compliant, efficient, and capable of meeting the highest regulatory standards. The key components of our validation services include:
User and Functional Requirements
We begin by defining and documenting the user and functional requirements, ensuring that the system is designed to meet the specific needs of your organization.
Validation Strategy and Plan
A well-defined strategy and plan are crucial for the success of any validation project. We carefully outline the steps, milestones, and resources required to achieve the desired outcome.
Validation Summary Report
Upon successful completion of the validation process, we provide a comprehensive summary report that documents the entire validation effort, ensuring transparency and compliance with industry standards.
Risk Assessment
Identifying and mitigating risks is a fundamental aspect of validation. We conduct a comprehensive risk assessment to address potential issues and ensure the safety and efficacy of your system.
IQ, OQ, and PQ Scripts
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) are critical steps in system validation. We develop and execute these scripts to verify that your system functions as intended.
Traceability Matrix
A traceability matrix is essential for demonstrating the alignment between requirements and testing. Our experts meticulously maintain this matrix to provide a clear record of validation.
Regulatory Compliance
Our team is well-versed in the principles and processes outlined in GAMP 5, which supports compliance with FDA CFR 21 Part 11 and EU Annex 11. We adhere to these regulatory standards to ensure that your systems meet the necessary criteria for data integrity and electronic record-keeping.
In conclusion, Computer System Validation is your trusted partner for computer system validation, ensuring that your ARISg and Oracle Argus systems are in compliance with industry standards and regulatory requirements. Our dedication to customization, efficiency, and risk mitigation allows you to approach validation with confidence, knowing that your systems are designed to meet the highest standards of data integrity and patient safety.
Contact us today to learn more about our computer system validation services and how we can tailor them to your organization's specific needs. With PinnApt Systems, you're investing in the reliability and compliance of your computer systems.