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CSV Auditing |
| Polaris conducts regulatory audits against applicable FDA predicate rules, Good Automated Manufacturing Practice (GAMP) (ICH Q8, Q9, and Q10 Guidance) and 21 CFR Part 11, the FDA regulations for Electronic Records and Electronic Signatures. The Polaris Part 11 Audit examines the security, recoverability, qualification, and maintenance of IT network infrastructure and all applicable Computer System Validation (CSV) documents. As with all audits, certain quality system elements and supporting processes are also assessed including: training, document control, corrective and preventative actions, and problem reporting. |
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| Benefit of System Audits for Gxp (GMP, GLP, & GCP) |
- Significantly reduces level of GxP system compliance risk via early detection of existing or potential areas of non-compliance
- Significantly reduce GxP system deployment cost and time
- Significantly reduce GxP system validation and maintenance documentation
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| Benefit of Auditing Systems to GAMP Guidelines |
- GAMP provides a globally recognized framework and language on GxP system, product, and process compliance and management
- Polaris maintains a strong and established partnership between ISPE/GAMP community and global regulatory bodies in publishing guidance to existing regulations
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| Polaris performs several different kinds of audits depending on your company’s needs. |
- Prequalification (Due-diligence) Audits allow customers to evaluate the quality and controls of prospective suppliers, thereby ensuring that the product or services being offered by the provider meets your company’s requirements.
- For-Cause Audits are conducted when there are known issues or concerns regarding the conduct of a study or the performance of a purchased product.
- Follow-Up Audits are normally conducted on an annual or semi-annual basis to ensure that the level of quality, service, and support is being maintained. Follow-up audits may also be necessary when there has been a major change in the supplier’s organization or when there has been a significant upgrade to the product.
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| Polaris will work with your company’s quality personnel to tailor a
CSV audit program that fits your needs. An audit agenda can be designed to focus on a particular functional area, business operation, or particular computer system, and can be structured for 1, 2 or 3 day on-site visits. Polaris CSV audits can include a review of the following: |
- Company Organization
- SOPs, Policies and Guidelines
- Personnel Qualifications and Training Records
- Review of System Validation (Development Life Cycle)
- Validation Plans
- Requirements
- Design/Configuration
- Test plans, scripts, protocols, and reports
- Traceability
- Change Control
- Quality Assurance
- User Documentation
- Configuration Management
- Document Control
- Installation and Maintenance
- Security and Recoverability
- Facilities Management
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“Best Practices”
Many firms providing products, applications, and/or services to regulated companies are not required to meet the federal regulations. For example: a pharmaceutical Company X that needs to acquire a software-based system for its quality control operations must meet the Good Manufacturing Practices (GMP, 21 CFR Parts 210 and 211), whereas, a software vendor -- strictly speaking -- is not required to meet these regulations. Nevertheless, the software vendor should be required by Company X to demonstrate that its design, development, maintenance, and support processes are documented and that the vendor demonstrates control over their product. In cases like these, Polaris’ audit program will still cover the same audit topics outlined above; however, the assessment will refer to whether or not the vendor is following standard industry (or “best”) practices.
GAMP Background
Good Automated Manufacturing Practice (GAMP) is a technical sub-committee, known as a COP (Community Of Practice) of the International Society for Pharmaceutical Engineering (ISPE). GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving FDA expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems. Since 1994, the organization entered into a partnership with the ISPE and published its first GAMP guidelines.
The goal of the GAMP community is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. Over the past several years, the GAMP COP and ISPE have partnered with leaders in the U.S. FDA to identify and develop guidelines and best practices for applying the electronic records and electronic signatures rule (21 CFR Part 11) to computerized systems used by members of the pharmaceutical and medical device industry. Additionally, GAMP leads the effort to harmonize the ICH guidelines for pharmaceutical development, quality risk management, and quality systems (ICH Q8, Q9, Q10) through the Process and Analytical Technology (PAT) group. |
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