Data Integrity
Data Integrity refers to the accuracy, completeness and consistency of data over its entire life cycle, and is a critical aspect to the design, implementation and usage of any system which creates, processes or stores data.
Whether it’s patient records, ERP data, lab reports, equipment or validation test data, a large amount of information is processed by different people in different systems. With patient safety at heart, Agidens has made Data Integrity a priority in its service offering and guides its customers to full data integrity compliance to ensure complete, consistent and accurate data.
Data Integrity assessment
A Data Integrity assessment highlights whether all critical data is well-managed, easily retrievable, traceable and archived throughout the entire data life cycle.
Suggestions are given for data protection from any type of modification, removal or fraud. With an extensive experience in assessment, remediation and implementation of data integrity, our experts make your data flows compliant with the existing standards and regulations, following the ALCOA+ model.
Regulations
Eudralex Volume 4 Annex 11 and FDA 21 CFR Part 11.
Guidances
FDA Data Integrity and Compliance With Drug CGMP, ISPE Gamp Guide (Records & Data Integrity) and ISPE GAMP5.
The process
- Set-up questionnaire for system owners and specialists
- Identify GMP critical records
- Analysis
- Create gap report
Identify high, medium or low risk data and procedures
Propose remediation plan, based on outcome, priorities and criticality
- Consulting of data integrity requirements
- Adapt process, procedures and systems according to data integrity requirements
- Best practice advice
- Introduction of data integrity policies and processes
- Training of staff
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Integration of data integrity requirements in purchase process and validation and qualification methodologies
Why Agidens Life Sciences as data integrity partner?
Based on over 20 years of experience with validation and automation projects in the life sciences industry we offer reliable, GxP compliant and tailor-made advice. We have an extended know-how on qualification, validation and compliance projects for both pharmaceutical and chemical companies and hospitals, varying from standalone equipment software qualification to a companywide implemented ERP system.
- Implement and support data integrity site programs
- Perform technical and procedural data integrity gap assessments
- Implement gap remediation activities
- In-house awareness training for laboratory workers or operators
- In-house specialist training (for groups up to 10 people)
- Yearly general training at Agidens headquarters
How can we help?
Is it Agidens Life Sciences you’re looking for? We’re eager to hear your questions or challenges.