Pharmaceutical Solutions for Manufacturing and Automation Engineering

Allurént is committed to providing manufacturing solutions and automation engineering in computer systems validation and regulatory compliance services in pharmaceutical manufacturing. Our dedicated group of automation engineers and manufacturing consultants focus on industry guidelines and regulations that directly affect the manufacturing of your pharmaceutical products.

The engineering team at Allurént Corporation can help your pharmaceutical manufacturing system achieve and maintain a competitive advantage by:

• Developing state-of-the-art pharmaceutical solutions for compliance
• Identifying specific actions necessary to become compliant throughout the pharmaceutical industry
• Automating the pharmaceutical manufacturing software validation process
• Implementing automated tools for validation and validation management
• Meeting validation schedules and critical path
• Minimizing the effort required for on-going regulatory compliance
• Improving operational efficiency of pharmaceutical manufacturing

Our services include a full range of pharmaceutical procedures, automated engineering tools and validation services to help enable compliance to 21 CFR part 11 and the EU Annex Part 11. Our work with computer automated pharmaceutical systems, including compliance with the U.S. FDA’s 21 CFR Part 11, is well known throughout the pharmaceutical industry. We leverage our pharmaceutical manufacturing expertise to provide systems, tools, policies and procedures for total compliance.

Allurént automation engineers also provide expertise and assistance in computer system validation of pharmaceutical products by applying proven and efficient solutions based on current standards required by the pharmaceutical industry. Through the use of risk analysis tools, we can define the scope and focus of your automated computer system validation process.

Our engineering team can assist you in defining and implementing your requirements involving automated computer systems software by providing the following services:

• Minimizing the effort required for on-going regulatory compliance
• Improving operational pharmaceutical manufacturing efficiency
• Prioritizing your computer system validation requirements (risk analysis and risk based approach)
• Creating a manufacturing system validation master plan and defining roles and responsibilities
• Defining system requirements, design and specifications (user requirements and functional specifications)
• Documenting and testing pharmaceutical manufacturing systems (test plans, test scripts, execution, failure report, traceability matrixes and test summaries)
• Providing computer validation training
• Auditing pharmaceutical automation software vendors
• Managing and implementing the pharmaceutical manufacturing system
• Validating prospective and legacy automation systems
• Ensuring compliance of electronic record/electronic signature (21 CFR Part 11)

Contact the engineers at Allurént Corporation for a no-obligation assessment of how our automated engineering and industry compliance solutions will advance your pharmaceutical manufacturing system.