Why Supply Chain Transparency and Data Integrity are ... - …€¦ · Title: Why Supply Chain...
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QA/QC manufacturing chemist Quality managers need to adapt quality systems to address the complexities that come with the globalisation and externalisation of good practice (GxP)-critical operations. Along the entire supply chain, transparency and data integrity are critical to establish processes that ultimately ensure that product quality is not compromised. Modern and business-centric applications, built on cloud technology, provide quality professionals with real- time visibility into data that is accurate and can be securely shared with other stakeholders, whether internal or external. This significantly reduces the effort required to obtain and review information that is critical for quality decisions, and it also prevents quality from being the bottleneck in the overarching product supply flow. Before we explore how cloud-based systems can help the business culture shift required and the end-user viewpoint, let’s look at how we got here. The externalisation of GxP-critical operations has been a continuous trend during the last few years. For example, manufacturing outsourcing has grown steadily, with cost reduction being a key driver. In fact, demand for outsourced services in manufacturing rose from $800m in 1998 to $2.5bn in 2014, and is forecast to reach $4.1bn by 2019, according to analyst group High Tech Business Decisions’ December 2014 industry study. 1 Externalisation inevitably leads to more process interfaces and fragmentation, according to further research. 2 In their December 2014 study, ‘The Top Ten Global Health Supply Chain Issues: Perspectives From the Field,’ authors Natalie Privett and David Gonsalvez identified a number of supply chain issues that result from this new complexity. This includes key issues such as a lack of co-ordination, management of inventory and orders, and visibility over shipments. Beside the fact that the common goals of a lean supply chain could be compromised, it becomes obvious that complex and fragmented processes lead to increased quality and compliance risks. Mitigation of those risks has cost implications, so the initial reduction of direct manufacturing costs through outsourcing may be eliminated by raising quality’s contribution to the cost of goods sold (COGS). But it’s not all about cost. When supply chain transparency is limited and quality is compromised, there could be a direct risk to public health and serious consequences for manufacturers. Many supply chain issues are directly or indirectly related to the availability and accuracy of critical information in quality control. Subsequently, leading regulators have acknowledged that the integrity of underlying data has become a major root cause of quality failure and compliance violations. The US Food and Drug Administration (FDA) states in its most recent publication: ‘In recent years, FDA has increasingly observed cGMP [current Good Manufacturing Practice] violations involving data integrity during cGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy and quality of drugs, and of FDA’s ability to protect the public health.’ 3 In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is taking a leading role in the data integrity discussion and has provided detailed guidance: ‘With support from the correct organisational culture, the next important element of successful data governance is to understand the data lifecycle. This will enable the implementation of a system, which is designed to assure the integrity of data throughout its life, beyond the limitations of data review. The data lifecycle considers all phases in the life of the data, from initial generation and recording, through processing, use, archiving, retrieval and (where appropriate) destruction. Failure to address just one element of the data lifecycle will weaken the effectiveness of the measures implemented elsewhere in the system.’ 4 The answer lies in the cloud The new reality is that accountability for quality and compliance goes beyond company walls and so does the ownership of data and its end-to-end lifecycles. However, traditional IT applications in quality have been considered internal 'back-office' systems, silos that were not designed to easily share information across a more virtual supply chain network. Cloud-based technology provides all stakeholders with access to accurate data in a single, authoritative system. It also empowers partners to be a part of the process. Now they can offer input, contribute data and improve the entire operation. Improved access, visibility and secure control requires an enterprise- wide, end-to-end system that’s easily accessible to third parties and that reliably captures data at the point it is generated. With a cloud-based approach, life sciences companies can actively control data that goes outside with appropriate restrictions on external access. All review and approval actions are tracked within Robert Gaertner from Veeva Systems makes the case that cloud- based collaboration increases productivity and transparency, and reduces quality risks in the life sciences supply chain Why supply chain transparency and data integrity are crucial for pharma quality “When supply chain transparency is limited and quality is compromised, there could be a direct risk to public health”
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Transcript of Why Supply Chain Transparency and Data Integrity are ... - …€¦ · Title: Why Supply Chain...
QA/QC
manufacturing chemist
Quality managers need to adaptquality systems to address thecomplexities that come with theglobalisation and externalisation of goodpractice (GxP)-critical operations. Alongthe entire supply chain, transparency anddata integrity are critical to establishprocesses that ultimately ensure thatproduct quality is not compromised.
Modern and business-centricapplications, built on cloud technology,provide quality professionals with real-time visibility into data that is accurateand can be securely shared with otherstakeholders, whether internal orexternal. This significantly reduces theeffort required to obtain and reviewinformation that is critical for qualitydecisions, and it also prevents qualityfrom being the bottleneck in theoverarching product supply flow.
Before we explore how cloud-basedsystems can help the business cultureshift required and the end-userviewpoint, let’s look at how we got here.
The externalisation of GxP-criticaloperations has been a continuous trendduring the last few years. For example,manufacturing outsourcing has grownsteadily, with cost reduction being a keydriver. In fact, demand for outsourcedservices in manufacturing rose from$800m in 1998 to $2.5bn in 2014, and isforecast to reach $4.1bn by 2019,according to analyst group High TechBusiness Decisions’ December 2014industry study.1
Externalisation inevitably leads tomore process interfaces andfragmentation, according to furtherresearch.2 In their December 2014 study,‘The Top Ten Global Health SupplyChain Issues: Perspectives From theField,’ authors Natalie Privett and DavidGonsalvez identified a number of supplychain issues that result from this newcomplexity. This includes key issues suchas a lack of co-ordination, management ofinventory and orders, and visibility overshipments.
Beside the fact that the common goalsof a lean supply chain could becompromised, it becomes obvious thatcomplex and fragmented processes leadto increased quality and compliancerisks. Mitigation of those risks has costimplications, so the initial reduction ofdirect manufacturing costs throughoutsourcing may be eliminated by raisingquality’s contribution to the cost of goodssold (COGS).
But it’s not all about cost. When supplychain transparency is limited and qualityis compromised, there could be a directrisk to public health and seriousconsequences for manufacturers. Manysupply chain issues are directly or
indirectly related to the availability andaccuracy of critical information in qualitycontrol. Subsequently, leading regulatorshave acknowledged that the integrity ofunderlying data has become a major rootcause of quality failure and complianceviolations.
The US Food and DrugAdministration(FDA) states in itsmost recentpublication: ‘Inrecent years, FDAhas increasinglyobserved cGMP[current GoodManufacturingPractice] violationsinvolving data
integrity during cGMP inspections. Thisis troubling because ensuring dataintegrity is an important component ofindustry’s responsibility to ensure thesafety, efficacy and quality of drugs, andof FDA’s ability to protect the publichealth.’3
In the UK, the Medicines andHealthcare Products Regulatory Agency(MHRA) is taking a leading role in thedata integrity discussion and hasprovided detailed guidance: ‘Withsupport from the correct organisationalculture, the next important element ofsuccessful data governance is tounderstand the data lifecycle. This willenable the implementation of a system,which is designed to assure the integrityof data throughout its life, beyond the
limitations of data review. The datalifecycle considers all phases in the life ofthe data, from initial generation andrecording, through processing, use,archiving, retrieval and (whereappropriate) destruction. Failure toaddress just one element of the datalifecycle will weaken the effectiveness ofthe measures implemented elsewhere inthe system.’4
The answer lies in the cloudThe new reality is that accountability forquality and compliance goes beyondcompany walls and so does the ownershipof data and its end-to-end lifecycles.However, traditional IT applications inquality have been considered internal'back-office' systems, silos that were notdesigned to easily share informationacross a more virtual supply chainnetwork.
Cloud-based technology provides allstakeholders with access to accurate datain a single, authoritative system. It alsoempowers partners to be a part of theprocess. Now they can offer input,contribute data and improve the entireoperation. Improved access, visibility andsecure control requires an enterprise-wide, end-to-end system that’s easilyaccessible to third parties and thatreliably captures data at the point it isgenerated.
With a cloud-based approach, lifesciences companies can actively controldata that goes outside with appropriaterestrictions on external access. All reviewand approval actions are tracked within
Robert Gaertner from Veeva Systems makes the case that cloud-based collaboration increases productivity and transparency, andreduces quality risks in the life sciences supply chain
Why supply chaintransparency anddata integrityare crucial forpharma quality
“When supplychaintransparency islimited andquality iscompromised,there could be adirect risk topublic health”
QA/QC
manufacturing chemist
also helps to simplify GxP compliancesignificantly.
Another benefit of migrating to thecloud is that the access to increasedvisibility in the supply chain will alsoenable data analysts to spot trends thatcould lead to even further efficiencies.
Cloud adoption is a strategic businessdecisionOnce a quality manager decides toinvestigate a cloud-based quality system,what considerations should they keep inmind?
The first thing to remember is thatmoving to cloud-based solutions is abusiness decision, not only an ITdecision. Cloud-based applicationsprovide a new way of making everyone’sjobs along the chain easier and moretransparent. The decision to move to acloud-based solution requires deep, fact-based risk assessment throughout thechain and buy-in from key decisionmakers. User adoption is also a keyconsideration as the staff must be happyto use the system, and users will requiretraining to make the most of the benefitsof using the cloud.
Security is also a concern. This iswhere the regulated cloud mattersbecause it means the vendor hasdesigned, built and validated the entirehardware and software stack for the solepurpose of providing applications to theGxP-regulated industry. There are manydefinitions of cloud computing around,and only a few of them are suitable forlife sciences.
When the decision for a cloud solutionis made, it can be quickly deployed.
Benefits can be seen in a very shortperiod of time, as secure and seamlesscollaboration is enabled once internalusers and external partners are live onthe system.
In a blog post, pharmaceutical ITexecutive Michael Hughes explainedthe benefits he saw migrating to a cloudIT organisation when he was head of ITat Kythera Pharmaceuticals: ‘Afteryears of steadily proliferating on-premise systems — and the array ofhardware and software that comes withthem — we’re finally seeing technologymove in the opposite direction. Intoday’s IT department, the next bigthing isn’t the pursuit of more — it’sconsolidation, harmonisation andshifting to the cloud. The difference inefficiency is having a significant impacton agility and the bottom line.Standardising on using the cloud haseliminated the time, expense, andhassle of maintaining hardware andsoftware in-house.’5
Many quality managers may havesome initial reservations about cloud-based technology. But moreorganisations see the value and arerethinking their system landscapes.When modernising quality managementsystems, cloud technology can be a keyelement in fixing underlying issues interms of quality oversight, externalcollaboration and data integrity.
REFERENCE1. Biopharmaceutical Outsourcing Continues toGrow, by Agnes Shanley, Pharmaceutical Technology(April 2016): www.pharmtech.com/dcat-2016-biopharmaceutical-outsourcing-continues-grow.2. The Top Ten Global Health Supply Chain Issues:Perspectives from the Field, by Natalie Privett andDavid Gonsalvez: www.sciencedirect.com/science/article/pii/S2211692314200002.3. Data Integrity and Compliance with CGMP,Guidance for the Industry Draft (April 2016):www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf.4. Good Manufacturing Practice (GMP) DataIntegrity: A New Look at an Old Topic, Part 1, MHRAblog: https://mhrainspectorate.blog.gov.uk/2015/06/25/good-manufacturing-practice-gmp-data-integrity-a-new-look-at-an-old-topic-part-1/.5. Life When You’re 100% Cloud, Michael Hughesof Kythera Biopharmaceuticals for Veeva Systems’blog: https://www.veeva.com/life-when-youre-100-cloud/.
CONTACT4280 Hacienda Drive,PleasantonCA 94588, USATel. +1 925-452-6500 www.veeva.com
the system with consistent audit trails,time stamps and reports. Thiscomprehensive view of data reduces therisk of mistakes, harmonising the entireecosystem.
We can see how cloud computingaddresses Privett and Gonsalvez’s keysupply chain issues — lack ofco-ordination, management of inventoryand orders and shipment visibility. Thecloud can provide a single source of truthwhere documents and correspondencecan be stored and easily retrieved, which
Leading regulatorshave acknowledgedthat the integrity ofunderlying data hasbecome a major rootcause of quality failureand complianceviolations
