Computer System Validation for Pharmaceutical Industry
Computer System Validation/ Compliance (CSC)
Computer systems validation (CSV) is an essential requirement within the pharmaceutical, biotech and medical device industries. Over the past decades, the life science industry has progressively introduced computer systems to support clinical trials, manufacturing, control, and logistics processes. As a consequence, these computer systems became critical elements from the point of view of current GxP regulations on electronic data integrity and therefore, the regulatory authorities have significantly increased their vigilance on the adequate control over electronic data systems.
To address current and dynamic nature of challenges, Pharmatek CSV experts brings unique capability to deliver best in class computer system validation/assurance audits. Our team of professional CSV auditors, have in depth experience of conducting CSV audits for both hosting environments “On Premise and Cloud” as per GAMP 5, FDA 21 CFR Part 11 and EU Annex 11 regulatory compliance requirements.
Our experts are familiar with widely used data management, EDC applications, safety database applications in a variety of environments for clinical trials and have audited validation packages for the core applications, both for local installations at contract research organizations (CROs), as well as at the software vendors.
Pharmatek CSV experts had conducted numerous audits in various countries USA, EU, Asia and Australia for entire value chain of pharma / life science industries including cGMP, GLP, GCP, GVP, GDP environments. In addition to regulatory compliance, our experts also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, record retention.
Pharmatek provides a wide range of CSV audit services to clients as per their specific project and budget needs.
Range of services
- Data Management Systems
- Electronic Data Capture (EDC)
- Safety database audits
- Electronic Diaries and ePRO Tools
- Interactive Response Technology (IVRS/IWRS)
- Laboratory Information Management Systems (LIMS)
- Data Centres
- Archiving and Data Retention
- Physical and Electronic Security
- Backup and Recovery