Data Management Service by QA Data Achieves High Level of Compliance

QA Data is delighted to announce it has achieved a ‘high level’ of compliance in the successful audit recently conducted on its entire Data Management Service (DMS).

The scope of the audit covered:
• Part 11 of Title 21 of the Code of Federal Regulation (CFR) as defined under the United States Food and Drug Administration (FDA) which defines criteria under which electronic records and signatures are considered to be trustworthy, reliable and equivalent to paper records and handwritten signatures (21 CFR Part 11).
• Good Clinical Data Management Practices (GCDMP) as documented by the Society for Clinical Data Management (SCDM).

Throughout the audit QA Data offered its full co-operation, the report praised QA Data for its transparent and professional approach providing very open and honest responses. Co-founder and Managing Director, Laurie Ben yair said “my team were more than happy to disclose any known weaknesses that QA Data is currently facing and details of how these issues are being addressed”.

The audit observed the following findings:
• QA Data’s procedures and practices are aligned with the principles of ICH GCP, 21 CFR Part 11 and Good Clinical Data Management Practices (GCDMP)
• QA Data employs suitably qualified and experienced staff
• QA Data has the necessary data management infrastructure and facilities
• QA Data has suitably experienced and qualified management and leadership

The auditor noted “no data management operation can ever be 100% compliant. There will always be a training file that needs to be updated, a staff member who requires additional training or an aspect of the infrastructure that could be improved. Consequently, it is more accurate to say that data management centres can therefore achieve either a high, medium or low level of compliance.” QA Data achieved a high level of compliance with GCDMP and Part 11, the auditor commented “in the case of QA Data (despite the few findings) achieves a high level of compliance and I’d happily entrust data to them”.

As well as auditing QA Data’s DMS the audit also assessed Study X, a study that QA data is currently conducting for a German pharmaceutical company. An in-depth Quality Assurance assessment was carried out which compared 780 data points in the database to the paper CRFs for accuracy. A data error rate is a significant data quality indicator, the auditor found zero discrepancies and concluded that Study X has a 0% data error rate which was described as “very impressive”.

As a result of this audit it is clear to see that QA Data has an excellent infrastructure in place to conduct its services in a competent and professional manner as well as being fully compliant with FDA and GCDMP guidelines and regulations.

About QA Data
QA Data is a South African, full-service clinical research data-management company. We pride ourselves in offering an efficient and unique mix of high-quality, flexible data management services to the pharmaceutical, biotechnology, medical device and CRO industries while at the same time being cost-effective.

Our services are in accordance with the highest quality standards namely ICH Guidelines and FDA Regulations, utilising a FDA validated clinical data management system and combining state-of-the-art technology with our professional expertise.

Using technology solutions, such as Electronic data capture (EDC), or conventional Paper our experienced and dedicated team effortlessly handle small phase 1 – to large-scale Post Marketing Surveillance studies.

For more information or to discuss Data Management Service by QA Data please contact QA Data directly.