Quality Assurance is not a necessary “evil”
It is a contributing factor to the success and growth of the company
WHAT DO OUR CUSTOMERS HAVE TO SAY ABOUT US
WHY CHOOSE US FOR AUDITING SERVICES ?
GCP AUDITS: REMOTE, ON-SITE, HYBRID.
• GCPS has an extensive auditing experience according to ICH GCP, ISO 14155 and various national, European and US regulatory requirements.
• Our auditors performed hundreds of GCP audits in many therapeutic areas and for various pharmaceutical, biotechnology and medical device companies
• As an international CRO, we face and solve real-life issues while running international and/or local clinical trials
• Our international GCPS team abound 30 nationalities! This is a tremendous asset as we have enough native speakers inhouse to support with all audit translations.
• We are proud for our – already 12-years – ISO 9001 certified risk-based QMS with our own developed software tools.
AND WHAT DO OUR QA EXPERTS HAVE TO SAY ABOUT AUDITS?
“I simply LOVE auditing, clinical research and training! My passion for quality and always keeping things moving forward started 20 years ago. I am extremely proud on my entire team! Such great achievements could not have been reached without passionate cooperation. I am honoured to be part of our QA family at GCPS.”
Head of QA
“I like the audit itself: being on-site and seeing the facilities, processes and documents after I got just a rough impression during preparation phase. I enjoy the (mostly) openminded discussions with the auditees and to see/hear other opinions and approaches.”
QAM
”
Every audit is a challenge! I enjoy preparing for the audit, going through the documents and guessing what awaits me with the auditee. The basis of the audit is an interview with the team members. I like to learn about other approaches and other possibilities of how the clinical research is conducted. I am happy when I see the desire and determination of auditee to participate in a study or project. I always learn something new and always pass on something new.“
QAM
“I do like to think about clinical trials in bigger picture. Moreover, it's never dull as you meet new people, dive into further indications and always move forward.”
Compliance Manager
"Professionalism, accountability and communication. Contact and planning with Petra Štěpánková, Head QA; smooth and ease of professional relationship. Timeliness, documentation, regular updates of audit planning and conduct, ease of communication with auditing team."
~ Head GCP Quality Management, IMP Client
„I am impressed with your QMS, how you have developed your own quality management system tools and how you understand and implement risk management at GCPS.“
~ ISO 9001 auditor, 20 years+ of experience
„I highly appreciate your hard, comprehensive and precise work, it can be seen from the reports!”
~ Clinical Program Leader, IMP Client
"Thank you again for the constructive collaboration. I very much appreciate your thoughts on the relation CRO – Sponsor and that you are sharing those. We will certainly pick up your suggestion.”
~ Clinical Operations Director, MD Client
"An amazing operations, wonderful systems and zero audit observations and that it never happened to me before.“
~ Vice President of Clinical Quality Assurance, IMP Client
TYPES OF AUDITS WE CAN SUPPORT YOU WITH
• investigational site
• vendor
• clinical laboratories
• essential documentation
• system & internal processes
• project compliance
• for cause
• pre - inspection
Founded in 2004 in Bremen, GER
Clinical Research Organization
30+ trials/year in MDs, IVD’s, IMPs
H.W.Visscher
Internal Feedback, Audits, and Team Performance
Background
Feedback: information on task performance delivered by co-workers or by auditors
Feedback Environment: contextual aspects of day-to-day feedback processes
Research question
Hypothesis: the feedback environment for external (auditor) feedback is rated equal to or higher than the feedback environment that is experienced for internal (co-worker) feedback
Methods
Empirical: survey study
Study population: seven clinical trial teams in one pharmaceutical company
Team size varied from 12 to 19 employees
Results
110 surveys sent out; response 61%
23 surveys validated and included
Fig. 1: the overall feedback environment experienced for external (auditor) feedback is rated significantly lower than the feedback environment experienced for internal (co-worker) feedback (p ≤ 0.05).
o This is the case for all constituent variables (except AFBU/FBU and AFBPS/FBPS).
Conclusion
The hypothesis is rejected.
Future research questions
More research in different organizations
o Is this result a general observation with regard to auditing?
o How to increase the perceived quality of external (auditor) feedback information?
o What is the impact on the acceptance of feedback?
o What is the impact on the effectiveness of auditing as a tool for improvement?
Clinical development teams value internal feedback from coworkers more than external feedback from auditors
Reference
Feedback was quantified by using the Feedback Environment Scale (Steelman (2004))
o Steelman, L.A., Levy P.E. and Snell, A.F. (2004). The feedback environment scale: construct, definition, measurement, and validation, Educational and Psychological Measurement, 64, 1, 165-184
In this study the factor supervisor feedback was replaced by auditor feedback (feedback delivered by clinical quality assurance auditors) as a type of external feedback.
Overall parameters
FES: Co-worker Feedback Environment Scale AFES Auditor Feedback Environment Scale
Seven facets of the feedback environment
(A)FBSC source credibility (= expertise and trustworthiness)
(A)FBQ feedback quality
(= consistency and usefulness)
(A)FBD feedback delivery
(= feedback recipient’s perceptions of the source’s intentions)
(A)FBF favorable feedback
(= perceived frequency of positive feedback)
(A)FBU unfavorable feedback (= perceived frequency of negative feedback)
(A)FBSA source availability (= perceived amount and ease of contact with the supplier of feedback)
(A)FBPS promoting feedback seeking (= the environment: supportive or unsupportive of feedback seeking?)
Statistical analysis
SPSS, version 14.0
Additional results
Note the difference in scoring for Source Availability (the pair AFBSA-FBSA): it is clear that the auditors are less easily available for feedback than the coworkers.
The relatively large difference for the Favorable Feedback (the pair AFBF-FBF) indicates that the team members experience a lower frequency of positive feedback from the auditors than from their co-workers (which is understandable, as auditors are focused in general on non-conformities).
Figure 1: Results external feedback compared to internal feedback parameters
Correspondence Henk Wicher Visscher, M. Pharm. Sc; M. Mngt. Sc. Arnhem, The Netherlands h.w.visscher@wxs.nl Results external feedback vs internal feedback (n = 23) 1.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50 5.00 AFES FES AFBSC FBSC AFBQ FBQ AFBD FBD AFBF FBF AFBU FBU AFBSA FBSA AFBPS FBPS Variables Score External Feedback (Auditor) Internal Feedback (Co worker) Team AB-123
Clavien, Quality Manager, Clinical Research Unit - Nestlé Research, Lausanne Switzerland
of clinical trial audits as a tool for quality improvement in nutritional clinical research
Evolution
International QA Conference Brighton UK, 9-11 November 2022 We evolved from a full manual data handling process performed on-site to partly or fully remote audits due to: - Covid-19 crisis - Decentralized clinical trials - Use of digital technologies On-site audit ✓ Reduced travel constraints & costs Documentation digitally accessible with appropriate cloud storage ✓ Higher flexibility ✓ Face-to-face meeting Only virtual facilities tour Technology dependance and know-how Dry-run necessary Key personnel availability Duration of audit condensed ✓ Proactivity & regular feedback ✓ Shorter Setup time e-meeting invitation ✓ Simultaneous auditing at different locations Mixed use of remote and on-site techniques Facility tour in person Adequate security for data protection ✓ Access ease to hard copy source documents ✓ Facilitated oversight and follow up ✓ Direct access to equipment’s & study procedures ✓ In-process checks ✓ Products physical inventory Access management ✓ Full safety (i.e., Covid) ✓ Off-site experts can be consulted ✓ Auditor temporarily physically present ✓ Multiple auditors can attend ✓ Shorter time on site ✓ Audit plan according to needs
Helene
Quality ASAP
By Shona Ross, Head of Quality Assurance
Don't overcomplicate solutions. Don't write SOPs that cover every single potential scenario - if it only happens 1% of the time, it's not the standard Systems that are onerous to operate or not designed for your organisation are unlikely to be successful
Why write a twenty-page SOP if a flow chart will cover it Electronic systems have their place, but is £20k the right investment now for a three-person company when you are all onsite
People view a QMS as complex and difficult Building it can seem daunting, but it does not need to be gold plated, with bells and whistles and coverage for every single situation that may potentially occur. It should be future proof so it can grow with the organisation. Taking the example of GLP, you may not be GLP just now but may want to join the programme in the future. Therefore build your system with that in mind, but don't build a fully GLP-compliant system from the start It is also important to note that one size does not fit all; what works for one company, may not work for you.
So…
How do we do that in regulatory and non-regulatory environments?
What do you need to think about?
Where should you expend the most of your energy to get the greatest benefit of either building a system from the ground up, or being able to rethink it and strip it right down?
Don't expect a QA person to build the SOPs for your entire company. Get the right people involved and allocate tasks appropriately then you understand that it isn't as big as you thought it was. When targeting the completion of your QMS: think SMART
Start at the beginning and do the right thing from the outset Plan and control it but don't be afraid to review and change it and don't be afraid to admit that you started one way but it s not the right path. In short, it may not be revenue-generating now, but it can add significant value to the business going forward.
Do what works for you; understand what you re doing and why you ' re doing it and just because it’s always been done that way, or it worked for you before doesn’t mean it’s the right solution this time.