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 data integrity audits to ensure compliance with relevant requirements such as the ISPE guidelines.

Identification and documentation of critical data

Documentation of data flows

Risk assessment and risk mitigation/controls for critical data

Review and implementation of procedural controls within QMS

Other Validation Solutions

The term ‘Validation’ is broad in scope and reach. It may refer to a study demonstrating that a facility complies with relevant regulatory requirements, or it may refer to an exercise showing the qualification of a specific plant process against a particular standard, or it could relate to an investigation to confirm the test results of a flow monitoring system are accurate to within the required tolerances via a secondary testing regime.

Synertec is certified to ISO 9001 (Quality), ISO 14001 (Environment), and ISO 45001 (Occupational Health & Safety). We understand what it takes to develop and maintain compliant systems and to support our clients with their own performance and compliance requirements.

Our experience and knowledge are centred around a team of expert engineers and scientists who have a deep understanding of the technology and processes across a wide range of industries and have hands-on experience implementing compliant solutions for these industries.