Validant. Strategic Consulting. Tactical Expertise.

Validant helps with resolving compliance issues and responding to an FDA 483, warning letter or product recall. Our proven track record of developing, managing and executing remediation workplans for multiple clients is unmatched. We rapidly deploy expertise to multiple manufacturing sites anywhere in the world to assist you with your mission-critical quality improvement efforts.

Validant works with clients to develop and monitor their systems to assure potential product complaint investigations are being appropriately investigated - managing data throughout the process to assure thorough and accurate complaint records are filed and concluded. In addition, we prepare complaint records, customer letters, MedWatch reports, vigilance reports and applicable complaint handling documents. Validant also performs retrospective audits of closed complaint files for thoroughness accuracy.

Regulated companies need to prove that they meet specific regulatory requirements. One such requirement is the accuracy and reliability of the tools and technologies used to manufacture, process, hold and distribute drugs, medical devices and other certain electronic devices. Validant provides:

• Installation, Operational, Performance Qualification (IOPQ) for your instrumentation and equipment
• Computer System Validation (CSV)
• Product and Process Validation
• Cleaning Validation
• Methods Validation
• Facilities and Utilities Validation

Being ready for an inspection at all times means having a solid quality foundation throughout your operation and ensuring that all employees recognize quality as part of their job function. Validant assesses existing quality systems, CAPA plans, remediation plans, quality process and product metrics, and makes recommendations on how to improve the overall quality system. In addition, Validant provides the expertise to implement the process improvement recommendations and transfer the knowledge to your employees, from assistance with training materials to mock inspections to verify readiness.

There are numerous benefits, such as reduced costs and shorter timelines, to outsourcing the production of medical devices, critical raw materials and biologics, bulk or finished products. However, cGMP Regulations consider 3rd party suppliers and Contract Manufacturing Organizations (CMO's) as an extension of your manufacturing facility and therefore must also maintain compliance. Validant helps you manage these relationships. We evaluate potential partners. We assess and audit existing partners to identify and correct potential gaps, ensure alignment with Corporate Quality System, drive standardization of templates and confirm suitability for intended use, design and manufacturing quality, and availability of high-quality validation documents. In addition, Validant can manage and direct a compliant technology transfer project.

Regulated companies operate under strict compliance guidelines. Validant performs a quality audit to verify conformance to these guidelines and the effectiveness of your quality management system. An internal audit assesses the operation's implementation of, and adherence to, processes and procedures that support the corporate quality system. An external audit evaluates CMO's and other 3rd parties' procedures.

Quality is the foundation for maintaining product and patient safety. Validant performs a comprehensive assessment of your cGMP compliance practices, production environments and quality management system. We help you understand where the potential issues reside, prioritize issues based on risk and severity, develop a plan of action to address issues and subsequently execute any activities required to resolve the issues. In addition, Validant develops and documents quality metrics to drive continuous process improvement plans.