Data Integrity

Data integrity is now increasingly
a point of focus for regulatory inspections!

IT Compliance

Data Integrity


Alongside a rising number of warning letters from regulators that address the topic of data integrity, a whole series of new regulations were also published last year by the FDA, EMA, WHO, PIC/S and others. Many of these regulations are still at the draft stage, and they show that the concept of data integrity and its associated requirements are still in flux. In the future, data integrity is likely to represent a new focal point for regulatory inspections. In all likelihood, the new regulations will be published in their final form by the end of this year or early next year.

Basic principles of data integrity

The keyword and acronym ‘ALCOA’ is commonly used as a mnemonic for the basic requirements for data integrity:

  • A = attributable
  • L = legible
  • C = contemporaneous
  • O = original
  • A = accurate


These attributes relate both to the actual data itself and to the metadata with which these data items are associated. Of particular importance is the process of making verified copies, where there is a key distinction to be made between static and dynamic data. These requirements should be implemented by using a Data Governance system as part of the Quality Management system.

Some of the measures that are required here include:

  • Assumption of responsibility by company management
  • Training
  • A risk- and lifecycle-based approach for handling data
  • Deployment of an audit trail and its routine monitoring as part of data releases
  • Periodical audits including self-audits and functional audits of the audit trail
  • Validation and safeguarding of computerised systems


DHC CONSULTING SERVICES FOR DATA INTEGRITY

Consulting

Data integrity check:

  • We help you to prepare for self-audits or vendor audits by providing you with a tailor-made strategy for your business (including training, audit checklists and final reports).
  • We are also happy to perform a friendly audit for your company so as to analyse your strengths and weaknesses when handling data.
Implementation

We provide you with support as follows:

  • Setup of your Data Governance system as part of the QMS, including process description and optimisation
  • Installation of suitable audit trail systems
  • Upgrading of your existing QMS to ensure conformity with ISO 9001:2015 and the latest data integrity guidelines
  • Generation and optimisation of your standard operating procedures (SOPs)
Services & Support

Data integrity training:

  • Our training portfolio comprises the topics of data integrity, audit trail auditing, quality assurance and qualification/validation – either on-premise at your business or remotely.
  • We are happy to show you the key areas in software validation/computer system validation and equipment qualification that you need to address in order to ensure data integrity.

WHY CHOOSE DHC?

Make use of our experience and industry expertise as validation and data integrity specialists:

  • Over 20 years of expertise in computer system validation
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
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Customers

WEBINARS AND EVENTS

06. September
German Webinar

Datenintegrität und computergestützte Systeme

Vorstellung der Anforderungen an die Datenintegrität computergestützter Systeme gemäß ALCOA sowie deren Umsetzung in Validierung und Betrieb.

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17. September
English Webinar

From SAP ERP to SAP S/4HANA

How do changes in S/4HANA, SAP’s new ERP system, affect GMP compliance?

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08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.