Validation Services Honeywell is a global solutions provider of software products and services for the regulated and consumer packaged goods industry. Our Validation Services assist clients by helping align their critical business systems to comply with applicable regulations. These Validation Services include detailed planning, protocol development, testing management, and validation consultation.

Software Validation testing of a computer system is accomplished when exact testing, precise analysis and appropriate sanctioning verify that the functional specifications consistently meet system requirements for the intended use of the software.

Honeywell’s extensive knowledge of FDA regulations related to software validation enables us to assist our customers in identifying which software applications need validation for FDA compliance, and which applications do not, thereby decreasing time to market and potential expenses.

Having a well created, thorough Validation Plan, including documentation and procedures, can also save companies from costly errors in the system that could result in delays, hazardous failures, and/or product recalls.

While it is desirable and more cost-effective to establish standard controls and testing plans concurrently with the product design and development phase, it is also necessary to ensure your company is not performing excessive testing.

We assist our customers in developing validation plans, to ensure the production of high-quality, safe and reliable products, which meet end-users’ expectations and regulatory requirements.

Benefits of a Lifecycle approach

Honeywell Validation Services follow a lifecycle approach towards validation, thus ensuring compliance with basic software quality principles of independent review, data integrity and security, and system reliability.

Our Validation Services offer the benefits of:
· Regulatory Compliance Analysis
· Risk management evaluation
· Master Validation Plan development and analysis for improved implementation time.
· High Return on Investment of implemented software systems
· Greater schedule visibility to assure milestone achievement and project success
· A qualified analysis of software systems

Honeywell Life Sciences oversees all validation and testing efforts in order to deliver the most time effective and cost-efficient software system. A typical implementation includes:
· Performing an assessment of critical needs
· Creating comprehensive project specifications for client approval
· Determining and delivering precise deliverables for each phase of the testing process
· Maintaining a traceability matrix of  forward and reverse mapping of functionality to requirements.
· Evaluating organizational personnel training and the effectiveness of the client’s operating procedures
· Executing the appropriate testing, utilizing best practices and industry standard tools.
· Re-testing to accommodate modifications resulting from ongoing changes and system maintenance

Designed by industry knowledgeable staff who are trained in FDA regulations and effective Quality Management Systems, our methodology addresses important validation activities:
· Software Configuration Management: change control, version control, and error reporting procedures

·Software Life Cycle deliverables: Requirements Mapping, Design, and Testing Documents
· Defect prevention plan
· Archiving/backup procedures and responsibilities
· Computer System Security procedures
· Computer System User Administration

Please contact us for further details on our Validation Services.