Makro’s Quality Assurance experts work to ensure compliance with the protocol, SOPs, and regulatory guidelines to ultimately ensure product safety as well as the integrity and validity of study data.
Our Quality & Compliance team conducts GCP, GMP, GLP and Computer Systems Validation audits at multiple stages throughout the clinical development process we support.
- Conduct specialized GCP auditing focusing on the issues associated with Phase I facilities
- Provide supporting Phase I training and SOP development
- Assess compliance with FDA regulations and ICH guidelines
- Evaluate the databases used to track SAEs and IND Safety Reports
- Review the contents of SOPs and Assess compliance with internal SOPs
- Verify that the protocol is performed according to applicable regulations, guidelines, and standards
- Review procedures for site visits and associated documents, such as monitoring reports and logs
- Review the content of SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations, including SOPs for AE/SAE reporting, subject randomization, study supply distribution, clinical monitoring, and data handling
- Development of Corrective and Preventive Actions(CAPA)
- Organization and personnel Audits
- Facilities and Equipment Audits
- Testing facilities operation
- Assessment of Labs for compliance with GLP regulations
- Records, reports and record/sample retention
- Audits of Facilities
- Audits of Vendors
- Audits of Clinical Supplies Service providers
- GMP Clinical Trial Materials
- GMP Quality Systems
- GMP Validation
- SOP writing to comply with 21 CFR Part 11
- Training to comply with 21 CFR Part 11
Computer Systems Validation Audits:
Makro’s experienced consultants are involved in the development, installation, operations and maintenance of computerized systems used in FDA compliant applications.
Our CSV experts have completed many mission critical clinical, laboratory, manufacturing and software implementation projects including:
- Experience in US FDA regulations and other international regulations of Computer Systems Validation with emphasis on 21 CFR Part 11, Annex 11 and other similar regulations
- Provide gap analysis, remediation plans, vendor audits, and project management
- VMware in regulated environments
- Software As A Service (SaaS) compliance.
- Utilize and assure compliance to the requirements like European standards (EN 285), European Clinical Trial Directive (2001/20/EC), Health Technical Memorandum 2010, and USP standards.
- Develop, implement, and maintain Quality Systems documents guidelines (PE 008-2), ISO standards, ICH regulations/guidelines, EP requirements, cGMPs, cGLPs, cGCPs, GAMPs and compliance to FDA Quality Systems Regulations.
- Work cross functionally on systems and lab instrumentation centric projects in GMP, GCP and GLP areas