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Data Integrity: Agidens makes sure that your data is safe

The use of information technology and computerized systems in all aspects of life sciences continues to grow. This has resulted in the generation of more data to support the development and manufacturing of products. Key decisions and actions are routinely being made based on this data, and the integrity of this data, whether in electronical or paper form, is of paramount importance to the industry, the regulatory agencies and ultimately the patient.

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, Agidens 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.


​​​​​​​AGIDENS OFFERS THE FOLLOWING SERVICES

  • Implement and support data integrity site programs
  • Perform technical and procedural data integrity gap assessments
  • Implement gap remediation activities

... AND TRAINS YOUR COMPANY

  • In-house awarenes training for laboratory workers or operators
  • In-house specialist training (for groups up to 10 people)
  • Yearly general training at Agidens headquarters


​WHY AGIDENS 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. 

We strive to support our customers in a cost-effective way with a risk based approach to comply with current regulations through the commitment of problem-oriented, multi-disciplinary teams with universal knowledge and experience.


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