Andy O'Connor
- Jan 23
- 2 min
ICH Q9 R1 - the highlights
Hurray! We applaud the new release of guidance around risk management to the life sciences with ICH Q9 Revision 1:...

Dr Eva Kelly
- Jan 4
- 4 min
Data Integrity - To Infinity and Beyond, starting 2023!
Having just welcomed 2023 and watched way too many animated movies (including a household favorite 'Buzz Lightyear'), I realized that...

Dr Eva Kelly
- Nov 4, 2021
- 8 min
Original GxP Record, The O in ALCOA+
Understanding what constitutes an original record and applying data management controls needs to be right up there with a clear...

Dr Eva Kelly
- Aug 26, 2021
- 5 min
The Art of 'Exception'
When ERA Sciences advise on test exception management for protocol execution issues, encountered during validation of on-premise, hosted...

Dr Eva Kelly
- Aug 12, 2021
- 8 min
Is Data Backup/Restore still a Pandora's Box for your organisation? Part 1
'Not all data is created equal' has become a much used phrase but for those in the Life Sciences and MedTech sector and those committed...


Dr Eva Kelly
- Aug 5, 2021
- 6 min
Data Flow Maps - No pain No gain?
Depending on your industry sector, the applicable regulations and the type of data and records being considered - data flow maps may be...

Dr Eva Kelly
- Jul 26, 2021
- 6 min
Avoid Ping pong meetings and inefficient decision making?
What holds up or derails our decision making process? How many times have we gone into a room with all the stakeholders there,...

Andy O'Connor
- Jun 8, 2021
- 3 min
How to be resilient to catastrophic events
The risk of unpredictable catastrophes, or 'black swans' have the capacity to be extremely painful for your company (and for you, too)

Dr Eva Kelly
- Jun 8, 2021
- 3 min
Data Integrity Culture - Does Hierarchy equal success?
Culture has always meant to me the 'who we are' the what we're about' and the acknowledgement that we may not be perfect and all need...

Dr Eva Kelly
- Jun 8, 2021
- 3 min
Data Integrity - Everyone's Responsibility
When it comes to personal data such as your bank details, any mistakes in your data may impact your savings, cash flow or even credit...

