Additional services that we can provide include but are not limited to those described below. We have an extensive background in GxP compliance for IT and Automation and can provide a broad array of services to assist with your project and compliance activities. Please contact us today for additional information.
- Strategy Development & Validation Master Planning
We can guide the development of your overall strategy for achieving and maintaining compliant GxP computer systems through careful collaboration, analysis, and planning with your team. Documenting a well organized and structured approach to the validation and operation of your GxP computer systems in your Computer System Validation Master Plan benefits management, personnel involved in the development, operation, and maintenance of the systems, and GxP auditors alike. - Mentoring and Coaching
Our specialist Mentoring and Coaching service enables a highly supportive environment for learning and actively applying new skills with appropriate feedback to ensure compliance objectives are satisfied. We will help your staff develop the internal knowledge and skills to plan, specify, build, and maintain compliant computer systems. - Documentation Review
We can provide independent review of project deliverables to assure conformance to Quality standards and requirements for the design, development, testing, maintenance, and operation of GxP computer systems. - Procedure & Protocol Development
We can develop appropriate policies and procedures for your Quality System standards to govern the design, development, testing, maintenance, and operation of GxP computer systems. We can also develop protocols and test scripts to support your validation efforts. - Interim Management
In the case of a loss of key personnel in the Validation, IT, or QA department, we can provide the experienced management oversight required to keep your validation and remediation projects on-track while continuing normal operations