Our Quality Assurance Services :
our Quality Assurance experts are able to evaluate your existing QA processes to ensure that they are current, and you are using the necessary best practices, as well as assisting you in the creation and review of standard operating procedures (SOPs) and quality issues management.
Valor has extensive experience in auditing computerized system vendors against regulatory requirements. We have undertaken many different audits over the years for many different systems in all areas of GxP. We focus on ensuring that systems are adequately documented and validated. We also evaluate whether systems are fit for their intended use and whether they are a good fit for our clients.
Valor is able to offer remote Quality Assurance services for smaller organizations who do not have a dedicated independent quality assurance resource.This approach means that we can facilitate collaboration between our Quality Assurance experts and your internal teams, whilst ensuring that fully compliant electronic quality records are properly maintained.
Valor offers services for the independent QA review of system documents in accordance with regulatory requirements and SOPs (Client or Valor). We have experience reviewing the following documents:
*System Specifications
*Validation Plans
*Risk Assessments
*System Descriptions
*Validation Testing Documentation
*Validation Summary Reports
*Change Controls
We can provide this review as part of an ongoing Quality Assurance oversight mandate or on an ad-hoc basis. We review this documentation against relevant regulations, SOPs and industry standards such as GAMP5.
Valor offers an SOP writing and review service to assure compliance with the current GxP requirements based on an initial Gap Analysis. Valor can assist in the preparation of SOPs that support the ongoing activities of our clients in addition to providing guidance for the implementation or revision of SOPs and forms to ensure compliance with regulatory requirements. We can also provide standard templates of SOPs, forms and checklists developed in compliance with ICH guidelines, FDA CFRs, EMA directives, Health Canada regulations and industry standards.
We have experience implementing and reviewing SOPs for the following:
*Clinical Data Management
*Quality Assurance
*Information Technology and Computer Systems Validation
Please contact us to learn more about the specific SOP services you are interested in.