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