Data Integrity, Electronic Records and Signatures
Data integrity is under intense regulatory scrutiny. Non-compliance can lead to severe consequences for pharmaceutical companies. This one-day course is essential for anyone involved in Pharmaceutical Quality Assurance or Computer Systems Compliance and Validation. By understanding and implementing robust data integrity practices, you can safeguard product quality, patient safety, and your organisation’s reputation.
Designed for professionals in the pharmaceutical and life science industries, this interactive course delves into the complexities of data integrity, 21 CFR Part II – electronic records and signatures. Through real-world examples, industry best practices and an in-depth focus on key regulatory requirements (including Annex 11 and Part 11), you will gain practical insights to enhance your organisation’s compliance and risk management capabilities.
Interested in data integrity training for your team? Contact us today.
This course is designed for professionals in the life science industry responsible for:
- GxP IT systems and infrastructure
- Manufacturing and laboratory operations
- Quality assurance and control
- Validation and compliance
It is also beneficial for IT service providers, software vendors and consultants working with life science companies.
This course covers the following topics:
Data Integrity concepts and principles
Regulatory requirements and guidance
Data governance and data life cycle
Applicable regulations (Annex 11, Part 11)
Data audit trail and review process
Regulatory citations and how to avoid them
Industry good practice
Achieving compliance in an effective way
Application of ideas and concepts to your systems
By the end of the course, you will:
Understand key data integrity concepts and terminology
Be familiar with applicable regulations (Annex 11, Part 11)
Regulatory guidance – and what they mean in practice
Know how to create and review data audit trails
Be able to identify and address regulatory risks
Implement industry best practices
Develop effective data governance strategies
Manage the data life cycle efficiently
Achieving compliance in an effective way
Apply of ideas and concepts to your systems
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.
Yes, the Data Integrity, Electronic Records and Signatures course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details.
Places will be available for you to book unless it states ‘Full’ next to your chosen Data Integrity, Electronic Records and Signatures course date. When this occurs, we operate a waiting list service.
Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems.
You will need to first register yourself on our booking system by selecting the Data Integrity, Electronic Records and Signatures course date that you wish to book your colleagues onto, then:
You will receive an automated email confirming your booking details for the Data Integrity, Electronic Records and Signatures course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included.
Usually, this 1-day Data Integrity, Electronic Records and Signatures course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000.
Our online Data Integrity, Electronic Records and Signatures course begins at 09:00am, although we request that you login at 08:30am to ensure any technical glitches can be resolved before the start time. Please review your course confirmation email to double check the exact start time of your specific course.
Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system.
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address.
Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email.
As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage.
Please see our 'minimum requirements' downument for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test.
Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees.
All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK.
Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development.
We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
