Computer System Validation

Computer System Validation

Azzur's Computer System Validation (CSV) process ensures the reliability, accuracy, and consistency in computer performance and the integrity of electronic records. We understand how crucial it is for computerized systems to help detect and stop any issues that could have negative consequences for the end user of a product, or violate the FDA's strict guidelines on the manufacturing supply chain and supporting systems. CSV is part of our comprehensive risk advisory services, along with IT Compliance.

Our subject matter experts are qualified to validate computer programs for businesses where FDA compliance is crucial, including businesses in the pharmaceutical, biotechnology, medical device, diagnostics, biologics and clinical industries. Our experts work with your team to ensure a validation strategy that is cohesive and works to not only keep your system compliant, but also allows you to work with maximum efficiency.

Our goal is to ensure that your technology is doing its job within the regulatory guidelines.
 

Azzur's Computer System Validation Services Include:

 

Risk-based Approach to Compliant GxP Computerized Systems

Azzur has significant experience helping companies define and implement a risk-based approach to the validation of their computerized systems. Our approach is flexible and can incorporate GAMP5(r), ICH Q9, as well as ISO methods to achieve an efficient and compliant approach.
 

Global Business/Supply Chain Management Systems Compliance

Today's global market demands that companies operate more efficiently than ever. Azzur understands the business needs of corporate environments and merges their business systems savvy with their regulatory compliance experience to provide solutions to the FDA regulated industry.  

Our experience includes the leading ERP, MRP, and Supply Chain Management applications, as well as Enterprise systems such as Document Management, Corporate Quality, and CAPA Systems. 
 

Manufacturing Systems Compliance

Our validation consultants provide assistance with Systems Validation, Control Systems Technology, Building Management Systems, Computer Integrated Manufacturing (CIM) and Manufacturing Execution Systems (MES) Compliance. Our highly trained consultants are experienced with a variety of manufacturing automation systems including: Distributed Control Systems, Flexible Batch Systems, PLCs, SCADA, MES, and Facility/Utility systems (*e.g. Building Management Systems, HVAC Controls, USP/WFI/RO/DI Water Systems). 
 

Laboratory Systems/Instruments Compliance

Azzur Group, LLC provides regulatory compliance consulting services to clients who need assistance with their laboratory environments. Whether the need is for validation of laboratory systems (e.g. Laboratory Information Management Systems (*LIMS), Chromatography Data Acquisition Systems) for qualification of instruments, Azzur can provide skilled, experienced consultants to handle the work.
 

IT Infrastructure/Component/Data Center Qualification

Azzur IT provides a process model for implementing an appropriate IT infrastructure (based on industry best practices) for supporting compliant systems. We focus on applicable regulatory predicate rules and Good Electronic Record Management practices. 
 

Cybersecurity Consulting

Cybersecurity is a major concern for every organization. A cyber attack not only puts intellectual property at risk, but can disrupt business processes. Our range of cybersecurity services includes information risk management, crisis management, operations and technology, regulatory and compliance, as well as implementing a security culture to empower team members to be aware and proactive. 
 

Sarbanes-Oxley Services

The Sarbanes-Oxley Act (SOX) is intended to prevent corporate financial abuse by ensuring the integrity of gathered and reported data. Azzur offers computer system compliance and validation services that relate directly to the SOX Act and helps our client's management team develop a strategy to ensure these standards are being adhered to.

We are able to help you target SOX compliance and validation needs in the following areas:
●    Standards & Compliance
●    Project Management
●    Disaster Recovery
●    Problem Management
●    Change Management
●    Security Management
●    Service Level Management