About Us:

Learn more about Our Team, Our Guarantee, President's Message, Mission Statement. The QA Edge team utilizes industry experts to deliver services and solutions to the Pharmaceutical and Medical Device Manufacturing industries.

Our Team

Joseph Schenk, President & CEO

Joe has trained thousands of pharmaceutical industry personnel on Part 11 assessment, computer validation and testing and has been involved in computer validation and software development for the past 22 years. Joe has an MS in Technology Management from the University of Pennsylvania and a BS in Commerce and Engineering from Drexel University. He has achieved certifications in Regulatory Affairs (RAC), IS Project Management (PMLG), Client Server Technology (Penn State), Mercury Test Suite, ISO 9000 Lead Assessor (BSI), and International Business (Drexel). He has published papers and delivered speeches on: Y2K Testing, Validation Issues for Electronic Signatures, Hazards Analysis, and Ensuring Proper Testing of Web-Based Regulated Applications. Joe started his career developing factory floor Supervisory Control And Data Acquisition (SCADA) Systems for British Petroleum and Hewlett-Packard. His validation career began in 1991 and validation projects have included: remote clinical data acquisition, clinical trial management, document imaging, indexing and management, adverse event reporting, toxicology, laboratory data acquisition, chromatography, LIMS, clinical supply stock management, regulatory publishing, medical devices, and CRO systems development quality assurance. Joe enjoys coaching his employees to be the best they can be.

David J. Renkiewicz, Manager, Vendor Alliances

David has trained hundreds of pharmaceutical industry personnel on Part 11 assessment and has been involved in computer validation and software development for over eight years. He has worked on software validation efforts in both the Banking and Pharmaceutical industries. David has a finance degree from Central Michigan University, and worked in the Banking industry, supplying accounting software, prior to his entrance into the Pharmaceutical industry. David is a member of DIA (Drug Information Association). His background includes assessing the validation and Part 11 efforts of all third party vendors, who want to supply applications to be used in their clinical trials, and all CRO's (Clinical Research Organizations) who want to be chosen to run clinical trials for this pharmaceutical company. Dave also provided validation consulting services on a major upgrade and rollout of Documentum and has recently attended Documentum training at the Documentum Users Conference.

Ken McKeown, Director of Operations

Ken has worked in the computer validation and software development fields for 19 years including 10 years at AstraZeneca. Ken has worked with the following software as either a project manager or as the lead validation consultant: Data Management, Remote Data Capture, Trial Management, Adverse Event Capture and Reporting, Medical Devices, and Clinical Supply Systems. He worked with a world-class pharmaceutical company training their subsidiaries around the world in GCP and 21 CFR Part 11. Ken has worked with a vendor in NYC to develop their SOP's and SDLC to support their delivery of a web-based collaborative services product to the pharmaceutical industry. Ken has a BS in Information Systems from St. Joseph's University and is a certified Project Manager.

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Our Guarantee

Any documents authored by QA Edge, Inc. will pass an FDA inspection or we will correct the documents at our cost.

QA Edge will always:

• Listen to our customers to insure that their needs are understood and expectations exceeded.
• Provide highly-trained consultants with the expertise in the process of developing high-quality, validated solutions.
• Sustain accountability for the value of the solutions and services that we provide.
• Focus on customer service excellence.
• Deliver high-quality, compliant systems in a manner that meets or exceeds our customers' deadlines.
• Maintain open and honest communications with our customers during each project.

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President's Message

From the Desk of
Joseph Schenk

Dear Friend,

You are a special person—you've chosen a career in the healthcare industry which contributes to helping people the world over, and we are truly grateful. My family and the families of our employees have been helped by your efforts and the tireless labors of hardworking, dedicated and clever people who share your passion for safe and effective healthcare.

We hire people who are eager and able to help you in your mission to help others. Our team of employees receives a great deal of satisfaction from helping you deal with the challenges and headaches of deploying high-quality, compliant computer systems in keeping with the meaningful deadlines that impact your company's goals and your professional success.

Do we have the answers to all your professional questions? Possibly not, but we do answer tough computer validation and Part 11 questions every day. We know what works and what doesn't in the notoriously vague realm of software project management and validation. And we can share this edge with your team so you can realize a faster return on technology investments and have peace of mind that your validation documentation will reflect total compliance and control.

We hope we can help you. We will always be thankful that there are professionals, like you, who make the world better for our loved ones every day.

On behalf of our company, I wish you every success.

Sincerely,

Joseph Schenk
President & CEO
QA Edge, Inc.

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Mission Statement

To be the vendor of choice in:

• Helping our clients achieve their schedule, cost and quality objectives using the knowledge gained from lessons learned during previous engagements.
• Maximizing the value they receive from all their regulated systems
• Having a guarantee of regulatory compliance

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