We apply the quality-by-design mindset, critical thinking and Computer Software Assurance concepts in our validation projects. CCG Solutions provides the following services to our GxP-regulated customers throughout the CSV lifecycle:
- Management and business consulting on GxP initiatives. Advise our customers on digital transformation initiatives with the ‘Quality by Design’ mindset
- Perform initial ‘health check’ of the validation status of our clients’ computerized systems, including gap analysis and risk assessment of “as is” validation state of processes based on GAMP criticality and compliance with applicable regulations
- Provide consultation on remediation of any identified deficiencies
- Project planning, GxP system classifications and collection of requirements (user, design, functional, regulatory) for prospective validation projects as well as remediation planning for retrospective validation projects
- Project management based on Waterfall methodology, Agile/Scrum framework, or hybrid project management models for the purpose of increased quality of deliverables, agility, efficiency, and alignment with customer expectations
- Preparation of CSV protocols, test execution protocols, traceability matrix and validation reports of computerized systems based on risk-based approach
- Validation of computerized systems that need to comply with industry regulations (FDA 21 CFR Part 11, EU Annex 11) and guidelines (GAMP5, PIC/S). Examples of computerized systems we have previously validated include:
- Quality Management Systems (QMS)
- Laboratory Information Management Systems (LIMS)
- Enterprise Resource Planning systems (ERP)
- Manufacturing Execution Systems (MES)
- Laboratory data acquisition and Chromatography Data Software (CDS)
- Clinical Trial Management Systems (CTMS)
- Electronic Data Management Systems (EDMS)
- Software used in Medical Devices for human use
- Creation and review of Standard Operation Procedures (SOPs) to ensure maintenance of the validated state of computerized systems
- Periodic reviews for computerized systems holding GxP data
- Quality Assurance Management including CAPA management, change requests, incidents, product quality reviews, document management
- Decommissioning and retirement of GxP systems from operation
- Train our customers on CSV and CSA methodology, QA good practices, data integrity principles and applicable industry and regulatory guidelines
- Train our customers on GxP audit good practices with the goal to ensure that project deliverables not only meet internal expectations, but that they also withstand regulatory audits as well
- Support with audit preparation and gap remediation to prepare our customers for regulatory, external and internal inspections
- Perform supplier audits based on applicable industry standards: ISO9001, ISO13485, ISO14644, ISO15378, ISO17025, ICH Quality Standards, 21 CFR Parts 11, 211, 820, Eudralex Vol.4
- Certified Quality Auditor (CQA) by the American Society for Quality (ASQ), Certificate number: 75336, for ISO and GxP audits of Suppliers to life sciences companies
- Provide CSV & CSA services to manufacturers of computerized systems and software solutions that provide their products and services to GxP organizations
- Create Software Quality Assurance Program with applicable SOPs
- Assist software suppliers to ensure and maintain compliance with applicable FDA/EU/GxP standards and guidelines
- Provide CSV and CSA training to improve alignment with industry regulations and guidelines