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    Commitment to Quality

Quality & Compliance

OmniComm is dedicated to improving healthcare worldwide.  We are committed to achieving and maintaining the highest standard of quality in all aspects of operation, and to continually meet or exceed the expectations of our customers for quality and performance.  

From development through general product release, it's all about quality and compliance at OmniComm. This level of quality has been accomplished by leveraging the latest technological solutions and regulatory standards and regulations such as:

  • US FDA: Title 21 CFR Part 11, Electronic Records and Electronic Signature
  • US FDA: Guidance for Industry for Computerized Systems Used in Clinical Investigations
  • US FDA: Title 21 CFR Good Clinical Practices
  • US FDA, General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11 2002.
  • International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6 (R2)
  • Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7)
  • Microsoft Technology Solutions

OmniComm has adopted an environment of continuous improvement and prides itself on developing quality products and services. We hold our employees to the highest standards and work to make every employee proud to be a contributor to the success of our company.

Quality Management System

OmniComm has a Quality Manual which describes the Quality Management System and serves as an overarching quality document, under which SOPs and all other associated quality processes are governed. The Quality Manual is used at all times by OmniComm employees, and is intended to provide adequate guidelines for all employees engaged in the activities of marketing, designing, developing, distributing and servicing our products, in accordance with regulatory guidelines and quality standards.  It establishes the following controls:

  • Management Responsibilities
  • Procedure Management
  • Corrective and Preventative Action (CAPA) Management System
  • Deviation Management
  • Internal Quality Audits
  • Vendor Selection Process
  • Vendor Audits
  • Training System

Any discrepancies or inadequacies within this manual are brought to the attention of the Compliance Committee for review and resolution.

Compliance Committee

The Compliance Committee is chaired by QA and serves as an independent body which governs all compliance-related activities at OmniComm Systems. Committee members establish and formalize a representative and independent body that has primary oversight of compliance activities to ensure all OmniComm business is conducted in accordance with company policies, SOPs, industry standards, and all applicable regulations. They also provide oversight to SOPs, audits, corrective actions and establish the company position on regulatory and compliance issues.

Activities deemed to have compliance-related requirements, such as SOPs, training, document control or establishing company position on regulatory issues, are brought to the attention of the Compliance Committee where they formulate a decision, take action, manage the project or compliance task, and/or prepare a proposal for review and approval by Senior Management.

Product Quality

The systems and processes used to manage clinical data are part of a regulated process that must be validated. Such a validation effort needs to meet FDA regulations and ICH guidelines as well as be reviewable and agreeable to clients. Every product that OmniComm Systems produces follows guidelines and SOPs that standardize design, verification, validation, change control, delivery and maintenance. OmniComm follows industry standards and best practices, including Software Development Life Cycle, System Validation and Quality Assurance Testing to ensure product quality.  

The foundation of OmniComm’s SDLC for the development of new products is based on a modified “V model.” The iterative nature of this model affords incremental development of the system requirements. Each increment provides an opportunity to view the system and jointly make course corrections as required. This model also promotes the early identification of risks and allows for effective mitigation of such risks much earlier than would be afforded by a non-spiral or non-incremental process. The objective is to gain a resulting quality product that closely matches user expectations. 

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Industry Standards

OmniComm supports several industry standards to assure the quality of our clients’ data. See the list and descriptions of the industry standards OmniComm supports.

Click here to see Standards Descriptions

Contact Us      North America +1 877.468.6332      Europe +49 (0) 228 227 440      Click Here to Email Us

Contact Us
North America
+1 877.468.6332
Europe
+49 (0) 228 227 440
Click Here to Email Us