Invensys Validation Technologies has the experience and qualifications to assess the tools, policies, procedures, and controls you have in place for the development and implementation of computer systems within the GxP environment globally.
As a global leader specializing in providing a full scope of validation services computer systems, software, facilities and equipment, Invensys Validation Technologies conducts assessments and audits to determine compliance. Our audit services are designed to help clients ensure conformance to cGMPS as well as emerging regulations.
Our proven methodology is designed to conduct an in-depth analysis that includes for all types of facilities, equipment, quality systems, and computer information systems including ERP, manufacturing, control and other automation systems. At the end of the audit, you will receive a written report documenting the results that include gaps and potential risks.
The report prioritizes and details key functions, areas or opportunities that should be addressed to reduce your risk
Our audit expertise includes:
- Building and factory automation systems
- Shop floor and smart manufacturing equipment (robotics, vision, etc.)
- Laboratory systems and LIMS
- Clinical trials/clinical research facilities
- Packaging systems
- Process and manufacturing computer systems
- Information technology/business systems
- Supply chain management systems
Our lead auditors combine years of experience with technical expertise, providing a cost-effective solution to audit and assess your needs using a risk-based approach.
Remediation and responses to FDA
Our experienced professionals are extensively trained to evaluate our client’s systems and documentation against the applicable regulatory requirements. Audits are conducted using the Invensys methodology that weighs the risks, benefits, costs as well as the client’s business objectives. Some of the areas that we focus on include:
- The impact of the regulation on the client’s operations
- Identification of areas, equipment, systems, etc for compliance
- Our client’s regulatory compliance objectives
- Review of client procedures
- Analysis of procedural documentation, validation and audit data
- Regulatory significance and impact on the client
An assessment report is given to our clients at the end of an assessment and will include information about:
- Applicable regulations and guidelines
- Level of compliance
- Areas of risk – including strengths and weaknesses
- Potential areas for warning letters and 483s
- Remedial plans and potential timetables
The report and presentation will detail all of the findings and will include suggestions for solutions that will minimize the client’s risk.
We can also assist your company with process qualifications, provide a turn-key solution for initial validation in preparation for pre-approval inspections, remediation or provide revalidation services.
