Alice Consulting LLC

Equipment Validation Engineering

Alice Consulting Validation Engineers manages, inspects, calibrates, tests and modifies the instrumentation, equipment, mechanics and procedures used to manufacture various products. They ensure all systems are running correctly and efficiently to produce high-quality products. They also investigate the causes of equipment failures and anomalies and decide if the equipment needs to be repaired or replaced.

Alice Consulting in-house staff of highly skilled professionals consults with you to determine your optimal strategy and immediate solutions. Our team also helps you with any resources for on-site tasks.

Alice Consulting Validation Engineer’s role will depend on the industry they work in and their specialism, but typical tasks include:

Monitoring and testing equipment

Analyzing and documenting test results

Preparing compliance reports

Directing validation activities

Resolving testing problems

Making adjustments or improvements to equipment and processes

Creating databases to track validation activities

Interpreting customer requirements

Developing validation schedules

Conducting training and overseeing the work of validation technicians

Maintaining instrumentation and equipment

Keeping up to date on industry standards and regulations

Cleaning Validation Engineering

A risk-based approach is followed for establishing an effective cleaning validation, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control.

Alice Consulting LLC provides consulting services in the following areas.

Cleaning Validation Regulatory Guidelines

Cleaning Validation Methodology

Analytical Development

Visual Examination – Sampling, Swab Sampling, Rinse Sampling

Analytical Testing and Reporting

Cleaning Validation Sampling and Testing

Worst Case Product Selection Matrix

Qualification and Validation

Computer System validation

Computer Systems Validation is not a one-time event. Validation should be considered as part of the complete life cycle of a computer system. This cycle includes the stages of planning, specification, programming, testing commissioning, documentation, operation, monitoring and modifying

Our computer system validation consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. our experienced CSV team can provide expert project planning and oversight that includes:

Validation Program, Procedure, and Template Development

Retrospective Evaluation of Legacy Systems

Continuous reassessment and re-validation

Automated or semi-automated processes, controlled by a DCS (distributed control system), PLC (programmable logic controller), or similar computer system Validation Certification Package Development

Process Validation

Having years of experience, our highly experienced team understands the concerns companies face in this highly regulated environment. The first step in process validation in manufacturing is to identify the risks and critical control points of the process. Which aspects of the process will impact product quality i.e. GMP risk, if they fail, or if they fall outside the control parameters?

Alice Consulting LLC provides consulting services in the following areas.

Quality Systems Regulation and Standards for medical devices and process validation

Design Control and Risk Management

Process validation prerequisites including validated test methods

statistics and quality metrics calculations

Verification versus Validation

Process development / Engineering studies and Design Controls

Design of Experiments (DOE)

Validating manual processes

Establishing methods for cleaning, facilities, utilities, and sterilization

Validation Process Failure Mode and Effects Analysis (PFMEA)

Process Monitoring and Control

Revalidation

Documentation for process validation

Validation Services

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Equipment Validation Engineering

Alice Consulting Validation Engineer’s role will depend on the industry they work in and their specialism, but typical tasks include:

Cleaning Validation Engineering

Alice Consulting LLC provides consulting services in the following areas.

Computer System validation

Our computer system validation consultants have extensive experience in providing leadership to companies seeking to meet regulatory expectations. our experienced CSV team can provide expert project planning and oversight that includes:

Process Validation

Alice Consulting LLC provides consulting services in the following areas.

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