Data Integrity Program

Regulatory agencies worldwide charge manufacturers in the life science industry with assuring that their products are manufactured in a manner that protects patient safety, product quality and data integrity. These concepts form the bedrock of the Good Manufacturing Practices (GMP) that govern the industry. Grantek offers data integrity auditing to help establish a baseline and identify gaps in data integrity that could result in failure to retain adequate records and/or potential regulatory agency observations.

Grantek’s Data Integrity audits cover more than 21 CFR Part 11 compliance; we assess the computerized systems using checklists and methodologies that follow ISPE GAMP guidelines to ensure we evaluate the customer’s systems against all applicable regulatory controls. The audit includes a risk rating for each identified item, as well as a remediation list to help prioritize corrective actions. This serves as the basis for a remediation plan to provide a path forward to meeting the data integrity guidelines.

Email info@grantek.com or call 866.936.9509 to learn how your operations can benefit from Grantek’s experience.

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Grantek’s complete solution for Data Integrity can provide:

⊙ Compliance Assessment – Grantek bases our data integrity assessments on a checklist template that is tailored for each customer based on the architecture of the target systems. Data is evaluated for each stage of production, from the machine PLCs all the way up to the Enterprise Resource Planning (ERP) reports. The assessment includes a compliance risk rating for each item.

⊙ Risk Reduction Plan – Grantek provides a risk reduction plan which is designed to help prioritize corrective actions and to determine a remediation plan per identified risk. This often includes administrative, configuration, date and time synchronization, e-record, record storage, security, and third-party vendor risks.

⊙ Design Solutions – Grantek will help to design remediation solutions and estimated costs for risks identified. Risk remediation designs may include projects, procedures, standards documentation for future systems, or a combination of these solutions.

⊙ Validation – Grantek may assist in validating a data integrity risk remediation solution through developing qualification documentation, change management documentation, and performing system tests.

⊙ Continuous Improvement – A continuous improvement and internal auditing program should be developed and followed with any data integrity improvement plan. These plans typically include proactive compliance checks, reviews of remediation projects against the risk reduction plan, and approvals of new projects that may alter existing plans or provide new data for consideration.

Data Integrity with Electronic Batch Records: Grantek’s Bryon Hayes Writes About this Crucial Topic for Control Engineering Magazine

FEATURED CASE STUDY

Data Integrity with Electronic Batch Records: Grantek’s Bryon Hayes Writes About this Crucial Topic for Control Engineering Magazine

Control Engineering Magazine’s July 2021 issue features an article which outlines why...

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