Sales Partners

QA Edge, Inc.
1 Hudson Way – Suite 100
Garnet Valley, PA 19061
P: 484 574 8643
P: 800 459 3363 (Toll-Free within US)
www.QAedge.com

Contacts

Joseph Schenk
P: 484 574 8643
P: 800 459 3363 (Toll-Free within US)

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About Us

Since 1995, QA Edge’s purpose has been to make computer compliance easy for FDA regulated firms. We provide ongoing Computer Validation services to 4 of the top 5 global pharmaceutical companies. More than 45 skilled consultants, plus a network of sub-contractors, help clients avoid costly mistakes through a superior range of Computer Validation staffing solutions, training, and do-it-yourself products.

Value Proposition

FDA expects that appropriate change control exist in order to maintain systems in a validated state. Users of SAP face considerable challenges and expense in being able to manage and deliver compliant change control. Industry research indicates that in 80% of instances, the root cause of a downtime problem is caused as result of a change, and 80% of the Mean-Time-To-Repair (MTTR) is spent determining what changed.

QA Edge, employing RSC’s Rev-Trac solution for integrated SAP change control, assists firms in solving these problems. The goal is to achieve operational excellence and automatic compliance that satisfies internal QA groups and outside regulators. To accomplish this, QA Edge offers the following services:

• Gap assessment to identify SAP change control problem areas and opportunities for improvement

• SAP change control methodology planning which is risk-based and appropriate for the organization’s culture

• Fast Track approach to Rev-Trac implementation and validation using our pre-defined validation package

• Staff solutions that are crafted for cost efficient SAP change process management and revalidation testing (including automated testing)

By using our services, clients employ risk-based methodologies that apply the right amount of Computer Validation rigor appropriate for the risk. We also have a key tenet that our validation efforts produce valuable communication which informs the stakeholders about the status of a project or change. The objective is to enable each team to deliver, on-time, the value that they promised the business unit.

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