RYAN BERTRAM


“Nothing in this world can take the place of persistence. Talent will not: nothing is more common than unsuccessful men with talent. Genius will not; unrewarded genius is almost a proverb. Education will not: the world is full of educated derelicts. Persistence and determination alone are omnipotent." -Calvin Coolidge

After a 12 year-old Ryan visited the Corvette factory in Bowling Green, Kentucky, he knew he wanted to part of how America makes things. With continued interest in the art and science of manufacturing, Ryan pursued his Bachelors in International Business at Calvin College. After graduating, he realized his dream of working with manufacturing by holding client relations positions throughout the manufacturing industry. At Malisko, Ryan enjoys bringing together the right people for the right job to tackle complex projects, and helping to bring the total solution to the client's plant floor.

Personal Passion
He likes spending time with his family and helping his children to blaze their own trail.

Dream Job
Build houses for Habitat for Humanity

Interesting Fact
He secretly likes the handy-man "fix-it" list his wife gives him every weekend. (Shhh! don't tell her that though!)

OUR APPROACH

COMPUTER SYSTEM VALIDATION DOCUMENTATION

Our documentation services are a crucial step in validating your manufacturing automation systems and reducing those risks. Through validation documentation, we meticulously document how your system works under normal, upset and recovery conditions, list functional requirements, provide detailed design documentation, help you generate relevant standard operating procedures and create execution protocols. This highly detailed process mitigates risks and greatly enhances your compliance with regulatory requirements.

COMPUTER SYSTEM VALIDATION DOCUMENTATION

Our documentation services are a crucial step in validating your manufacturing automation systems and reducing those risks. Through validation documentation, we meticulously document how your system works under normal, upset and recovery conditions, list functional requirements, provide detailed design documentation, help you generate relevant standard operating procedures and create execution protocols. This highly detailed process mitigates risks and greatly enhances your compliance with regulatory requirements.

VALIDATION MASTER PLAN

We start our documentation process by creating a Validation Master Plan (VMP) that guides every aspect of the validation process. The VMP defines your facility’s areas and systems that will be validated and provides a written roadmap for your facility to achieve and maintain validation. The VMP will include computer system validation, facility and utility qualification and validation, stakeholders and participants, equipment identification and summary of documents. This document shows auditors and inspectors a well-planned validation strategy with logical reasoning based on a risk assessment.

FUNCTIONAL REQUIREMENTS SPECIFICATION (FRS) DEFINITION

When we define the functional requirements of your system, we document what your process control system should do and specify its required behavior. We provide you, your team and auditors with a comprehensive written description of your system’s operation and planned performance. The FRS becomes one of the foundational pieces we use to create an operational protocol necessary to validate your process operation.

Detailed Design Specification The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies the how each system component is to be configured as well as how each component factors into making a completed automation system.

DETAILED DESIGN SPECIFICATION

The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies how each system component is to be configured as well as how each component factors into making a completed automation system.

TEST PLAN

The Test Plan specifies precisely how we perform off-site system integration testing and on-site validation testing on your hardware, software and networking components after completing code development and then after completing on-site process commissioning and system installation. Before your system handles any live runs, we test it in both a simulated environment and on-site at your facility. Through rigorous testing, we reduce your operational risks, and make validation protocol execution much smoother and more efficient.

TRACEABILITY MATRIX

In the Traceability Matrix, we define the relationship between the Requirements Specification Documents, Design and Functional Documents, and Validation Protocol Test Scripts. We use the Traceability Matrix to ensure that system validation addresses all requirements, specifications, and functions that were noted in the system specifications. The Traceability Matrix provides you evidence and a documented cross-reference to show that your automation system meets the stated requirements and specifications.

GENERATE STANDARD OPERATING PROCEDURES (SOPs)

SOPs relating to a validated manufacturing automation system are essential for the proper sustainability of the system throughout its life cycle. Topics covered by SOPs include document storage, change control, disaster recovery, training, audit trail, system updates, periodic reviews and system retirement.

With proper SOPs, you have repeatable, unchanged processes, procedures, and documentation that allow you to identify the causes and effects of any system issues through ongoing system performance tracking. We don’t just meet regulations. We help you use SOPs to stay compliant with regulatory regulations while keeping your production at maximum efficiency and achieve uniformity throughout your production process.

GENERATE INSTALLATION QUALIFICATION PROTOCOLS

The Installation Qualification (IQ) verifies the proper installation and configuration of your system. Your IQ ensures that necessary software modules have been loaded, equipment has been installed, configured and calibrated, the necessary procedures have been approved, and the appropriate personnel have received the appropriate training. The IQ follows the installation requirements that we define in the Detail Design Specification. IQ must be performed before completing the Operational Qualification or Performance Qualification. Through the IQ, we validate the installation and configuration of your system and keep you in compliance.

GENERATE OPERATIONAL QUALIFICATION PROTOCOLS

The Operational Qualification (OQ) is a collection of test scripts we use to verify that your system functions properly under normal, stress, upset, recovery and abort conditions. Through the OQ, we validate that your system will work and make it straightforward for auditors and inspectors to verify your system’s repeatable operation as designed through documented evidence. We perform the OQ before the system is released for production use.

INDUSTRIAL AUTOMATION FOR RESULTS

In our more than 20 years of helping manufacturers, we’ve intelligently applied automation for hundreds of companies across a wide range of industries. And we’ve earned repeat business from 90 percent of our clients.

Have a question or do you want more output, fewer lost batches and better reports? We can show you how to improve your production and maximize your successes through industrial automation.

500 N BROADWAY SUITE 1600 ST LOUIS, MO 63102

(314) 621-2921

500 N BROADWAY
SUITE 1600
ST LOUIS, MO 63102

(314) 621-2921