Data Integrity and ERES
Data Integrity, Electronic Records and Signatures, CFR 21 Part 11
We can help ensure your systems comply with the latest guidance and regulations for Data Integrity, Electronic Records and Signatures. Whether it is working with your own internal Data Integrity and ERES Compliance and Assessment process or, through our own ERES and 21 CFR Part 11 Control Framework and Data Integrity support.
We can help you in the implementation project management and deliverables production including:
- Data Integrity Policy & Governance Definition.
- Data Integrity Audit Programme/Audits.
- ERES/21 CFR Part 11 Compliance Assessment.
- Specification of Risk-based ERES Controls Tailored to suit your organisation.
- Integration of Controls with System and/or QMS Documentation.
- Remediation Plans and Remediation Management.
- Compliance Reporting.
We are a UK based Pharmaceutical Consultancy specialising in Data Integrity, Computerised System Validation and IT Quality Assurance services. TS CSV QA’s mission is to deliver pragmatic fit for purpose solutions to our clients to support technological implementation and innovation in the Pharmaceutical and Healthcare sectors. Founded by Trev Simmons, Trev is a Fellow of the Research Quality Association, and an active member of the association, and is currently Chair of the Digital Information Governance and Information Technology (DIGIT) Committee as well as the Cross-GxP Working Party on Data Integrity.