PharmaLex – powered by Arbour Group
Computer System Validation
PharmaLex has merged with Arbour Group to deliver specialized software testing services and validation solutions to Life Science companies to ensure compliance with applicable regulatory guidance required by the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), European Medicines Agency (EMA) and other international regulatory authorities.
Computer system validation provides documented evidence that software applications meet their intended uses by testing regulated functional processes as well as requirements related to electronic records and electronic signatures. Computer system validation, an essential for competent risk management, improves product reliability, increases patient safety, and ensures the systems are running accurately within regulatory requirements. To maintain validation of your system in a time and cost-efficient manner, PharmaLex – powered by Arbour Group follows a proven software testing process following GAMP 5 standards:
- Assessment of critical needs
- Project specifications with company approval
- Objectives for each software testing phase
- Testing script matrix for cross referencing all testing
- Commercial and proprietary tools to execute testing
- Report of comprehensive testing, including metrics of completeness
- Maintenance of a validated state following updates
Our computer software validation expertise includes a wide range of enterprise software applications. Our validation process also addresses procedural controls related to change management, data integrity, and training records. A maintenance program also provides a cost-effective way to stay in compliance.
Validation deliverables include:
- Validation Plan
- User Requirements and Functional Specifications
- Risk Assessment
- Requirements Trace Matrix
- Test Protocols
- Executed/documented test scripts
- Validation Summary Report
PharmaLex – powered by Arbour Group is dedicated to help raise your company’s quality levels, increase shareholder value, and reduce costs as we have done for over 25 years, supporting over 250 companies in the Life Sciences. Whether it is pharmaceutical, biotechnology, medical device, or commercial business software, Arbour has computer software validation solutions. From multinational firms to small, medium-sized businesses, companies in the life sciences choose Arbour Group to implement a holistic compliance approach, delivering regulatory expertise and methodologies to achieve your validation goals.
- Knowledgeable software specialists
- Expertise with regulatory agencies
- Warranted Deliverables
- Time-tested methodologies
- Comprehensive predefined test cases
- Remote project execution through international testing facilities
- Knowledge of commercial software testing tools
PharmaLex – powered by Arbour Group ensures software compliance and functionality that can support product marketing programs, complement new business initiatives and help maintain a competitive posture.
- Custom Software Development
- Lab Tools
- SMARTENOVAL – analytical method validation software
- SMARTSEELVA – bioassay validation software
- SMARTSTABELITY – product stability and shelf-life estimation software
- SMARTTRANSVAL – analytical method transfer software
- Statistical Services
- Statistical Training
- Statistics Software Login
What our clients say
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe
We really appreciate your responsiveness and availability during our previous exchanges and it is what we are waiting for from our partner.
Head of Regulatory Affairs