Data Integrity

The integrity of data from its creation and throughout its lifecycle to destruction is imperative to ensuring patient safety, efficacy and quality of pharmaceutical products. To ensure the integrity of data we adhere to the ALCOA+ principles; attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and viable.

Data integrity starts with identifying and documenting critical data, meta data and data flow. Critical data is regulated data used for a specific GxP purpose; metadata provides data attributes that give content and meaning to individual data points; and data flow provides information regarding the creation, processing, use, storage and eventual destruction of data.

Risk Assessments

Risk assessments are completed to ascertain any weaknesses of the data with regards to the ALOCA+ principles and where risk may exist to product safety, efficacy and quality throughout the data lifecycle, leading to the establishment of relevant mitigations.

This methodology to identify data, risk assess data, recognise associated risk controls and establish continuous monitoring should be embedded within an organisation’s Quality Management System. Doing so provides the data governance for the control of data by people, technology and procedural controls. It should be noted that data governance is required for paper-based systems too.

With in-house data integrity specialists, Synertec can conduct comprehensive independent risk assessment and data integrity audits to ensure compliance with relevant regulations and in line with relevant guidances such as the ISPE guidelines.