Pharmaceutical & medical
can now monitor, analyse and model far more data than ever before, which has led to significant advances in drug discovery and development. Automated machinery has also allowed production to expand at an unprecedented scale giving more people greater access to the medicines they need. However, running in parallel to this
T
progress has been a growing threat to data integrity – the foundation on which businesses in this sector maintain their reputations and develop new opportunities. Indeed, the previous two decades are arguably defined as much by regulatory oversights and human error as they are by advances in technology. In 2019, for example, the US Food and Drug Administration (FDA) issued over 90 warning letters, extending a pattern of failures that can be seen across the premarket side of the industry since the turn of the millennium. In most cases, warnings are issued for
similar reasons. One study that analysed FDA letters in the US between 2007-2018 found that most were issued for failing to follow and maintain correct procedures or poor documentation practices. The same study concluded that cases of required action were on the wane, and a growing number of businesses were compliant with stricter industry guidance. This is clearly positive news but also a situation that cannot be expected to remain the same. Data integrity is an ongoing process, rather than a static state, and requires businesses to be aware of potential threats ahead of production. This article looks beyond some of the well-known
he improvement of processing power over the past 20 years has fundamentally changed manufacturing, not least in the pharmaceutical sector. Businesses
Emerging challenges for data integrity in the pharmaceutical sector
issues, such as the continued use of paper- based records, and instead looks at some of the latest challenges and opportunities.
Data IntegrItY anD Its ImPortanCe Data integrity is relatively easy to define but difficult to manage. Businesses across the sector are expected to follow guidance, including companies responsible for clinical trials, research, manufacturing and distribution. Any information generated must be complete, accurate and consistent without any deviation from prescribed methods set out in guidance. It should also be collected, stored and maintained using secure methods. The acronym ‘ALCOA’ can be used to
better understand what is required from businesses. It stipulates that all data should be attributable, legible, contemporary, original and accurate. Beyond this, there is an expectation that data should be accessible at all times, particularly because auditors can arrive with little notice. There are countless decisions made each
day in drug manufacturing facilities, all of which can directly impact human health. Data integrity procedures are ultimately there to ensure a company is producing a consistently high-quality product. Those with accurate information have the means to
By Peter Cusworth, industry development manager for the Controls and Instrumentation Business Division at Yokogawa
demonstrate good practice and can quickly identify where oversights are being made, should they be flagged. Beyond this, data integrity maintains the pharmaceutical industry’s reputation and those working in it while also assuring the public that products are safe for consumption.
aCCess PrIvIleges Digital systems adhering to good manufacturing practices will use strict controls to maintain the reliability and integrity of data. This includes procedural controls, technical checks and audit trail reviews – however, many organisations fail to account for the risks associated with privileged access. This essentially grants someone the power to carry out critical administrative tasks, such as issue resolution or a change in monitoring parameters, often without traceability. Unsurprisingly, this situation is not viewed kindly by auditors as it violates one of the ALCOA principles – namely, that data should be attributable. While privileged access does not
compromise a system per se, guidance is nevertheless clear that facilities should avoid reliance on so-called ‘God accounts’ with minimal limitations. It significantly raises the chances of human error that could lead to falsification or data falling out of specification, not to mention give disgruntled employees or inside actors the opportunity to purposely do damage. The latter may be an extreme example but cannot be discounted in an industry known for placing high pressure on teams to produce positive outcomes for influential clients. The solution here is to avoid using a single
administrator account by splitting privileges between the IT and OT domains. This ensures one person is responsible for users and the types of data they can access, and another for the instruments and information collated on
18 January 2022 Instrumentation Monthly
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74
