Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations. Following assessment, our experts provide a detailed report including all observations, deficiencies, and a risk-based corrective action plan for improvement.
With an enhancement plan in place, our quality professionals will work closely with you to provide recommendations, resolve compliance issues, track corrective actions, and communicate the status of resolutions with company management. This comprehensive approach to vendor/supplier quality management strengthens your vendor/supplier relationships while ensuring your products are of the highest quality through a quality system that is compliant and efficient.
Our vendor/supplier auditing services include:
- Vendor/supplier audit plan strategy and creation
- Vendor/supplier audit execution and project management
- Vendor/supplier audit plan maintenance and support
- MDSAP strategies and audit implementation
Pharmacovigilance (PV) auditing is essential when balancing the risks and benefits of a new drug, biologic, or medical device. As regulators step up pharmacovigilance and place greater scrutiny on pharmacovigilance Quality Management Systems, it's up to you to assess internal activities, vendor relationships, commercial partnerships, and others that comprise the pharmacovigilance system.
Our professionals have firsthand experience in quality management for pharmacovigilance systems. We will help you audit current pharmacovigilance systems to ensure regulatory compliance while providing your internal team with the training it needs to maintain quality processes in the future.
Data Integrity Auditing & CSV
Compliance with cGMP requires companies to record, track, manage, store, and easily access documents such as Standard Operating Procedures (SOPs), Batch Records, Test Data, and log books. Current regulations also require manufacturers to review Electronic Batch Records (EBRs) of manufactured batches and resolve all discrepancies prior to batch release. EBRs consisting of electronic records should be reliable, trustworthy, traceable, and verifiable to conform with the US FDA’s 21 Code of Federal Regulations (CFR) Part 11 and the European Union’s Annex 11.
Our data integrity, validation, and quality experts perform comprehensive computer systems and data assessments to ensure your system requirements are fully met and adequately documented.
Data governance and management practices are evaluated using risk-based validation strategies to protect the integrity of your data and strengthen your quality system in the process. Compliance gaps identified during the assessment are addressed through comprehensive remediation.
Thorough computer system validation (CSV) ensures your system stands up to scrutiny, leaving you secure in the knowledge that your data is safe, reliable, and available. Our CSV experts implement systems and obtain “fit for use” certification in the areas of computer and cloud systems validation and data integrity.
Our framework for CSV and data integrity assessment can be applied to both proprietary and commercially available software. Projects are planned and executed by leading computer system validation experts with intimate knowledge of current regulatory requirements and years of experience enhancing IT operations, control systems, and data integrity for pharmaceutical, medical device, and biotechnology companies.
- Our comprehensive data integrity and computer systems validation services include, but are not limited to:
- Computerized and Cloud System Validation (CCSV) and qualification
- Establishing data integrity infrastructures
- Third party CMO audits
- Vendor audits
- Mock Pre-Approval Inspection (PAI) audits of data integrity
- Formal risk assessments and risk mitigation strategies
- Additionally, we assist clients in:
- Planning and remediation assistance for data integrity gaps
- Guidance and development of Data Governance and Data Management Programs
- FDA-483 and warning letter responses for data integrity
- Pre-audit preparation and support during audits
- Training and development of training programs in data integrity and CSV