The recent spate of regulatory agency citations on Computer System Validation (CSV) and Data Integrity (DI) is the primary reason for making DI a part of the Pharmaceutical industry’s lexicon.
Having expert CSV and DI audits and a remediation blueprint is imperative for the organization’s success in the current regulatory environment. This plan or blueprint needs to include effective data governance and a bullet proof data management system. Though the IT department leads the efforts for CSV and Data Integrity implementation, without the technical knowledge of the various GMP related functions, such a plan cannot be implemented or be effective.
Microrite’s unique cohesive and complementary approach to CSV and Data Integrity audits includes highly experienced subject matter experts in CSV as well as cGMP ensuring that the audit and remediation is justifiable during regulatory inspections.
CSV audits include review of design, development and testing of computer systems to conform to current regulatory requirements and GAMP 5.
Data integrity audits in quality assurance, quality control, manufacturing, validation, metrology and maintenance are tied to both CSV and the data integrity part of the assessment. This allows our team to adopt a holistic approach to identify the contemporaneous, attributable and consistency related aspects of data which is the focus of the regulatory audits.