QA/QC

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 Why supply chain the entire supply chain, and data integrity are critical to establish processes that ultimately ensure that transparency and product quality is not compromised. Modern and business-centric applications, built on cloud technology, provide quality professionals with real- data integrity time visibility into data that is accurate and can be securely shared with other stakeholders, whether internal or external. This significantly reduces the are crucial for effort required to obtain and review information that is critical for quality decisions, and it also prevents quality from being the bottleneck in the pharma quality overarching product supply flow. Before we explore how cloud-based systems can help the business culture Robert Gaertner from Veeva Systems makes the case that cloud- shift required and the end-user based collaboration increases productivity and transparency, and viewpoint, let’s look at how we got here. The externalisation of GxP-critical reduces quality risks in the life sciences supply chain operations has been a continuous trend during the last few years. For example, manufacturing outsourcing has grown indirectly related to the availability and limitations of data review. The data steadily, with cost reduction being a key accuracy of critical information in quality lifecycle considers all phases in the life of driver. In fact, demand for outsourced control. Subsequently, leading regulators the data, from initial generation and services in manufacturing rose from have acknowledged that the integrity of recording, through processing, use, $800m in 1998 to $2.5bn in 2014, and is underlying data has become a major root archiving, retrieval and (where forecast to reach $4.1bn by 2019, cause of quality failure and compliance appropriate) destruction. Failure to according to analyst group High Tech violations. address just one element of the data Business Decisions’ December 2014 The US Food lifecycle will weaken the effectiveness of industry study.1 “When supply and Drug the measures implemented elsewhere in Externalisation inevitably leads to chain Administration the system.’4 more process interfaces and transparency is (FDA) states in its fragmentation, according to further limited and most recent The answer lies in the cloud 2 research. In their December 2014 study, quality is publication: ‘In The new reality is that for ‘The Top Ten Global Health Supply recent years, FDA quality and compliance goes beyond compromised, Chain Issues: Perspectives From the has increasingly company walls and so does the ownership Field,’ authors Natalie Privett and David there could be a observed cGMP of data and its end-to-end lifecycles. Gonsalvez identified a number of supply direct risk to [current Good However, traditional IT applications in chain issues that result from this new public health” Manufacturing quality have been considered internal complexity. This includes key issues such Practice] violations 'back-office' systems, silos that were not as a lack of co-ordination, management of involving data designed to easily share information inventory and orders, and visibility over integrity during cGMP inspections. This across a more virtual supply chain shipments. is troubling because ensuring data network. Beside the fact that the common goals integrity is an important component of Cloud-based technology provides all of a lean supply chain could be industry’s responsibility to ensure the stakeholders with access to accurate data compromised, it becomes obvious that safety, efficacy and quality of drugs, and in a single, authoritative system. It also complex and fragmented processes lead of FDA’s ability to protect the public empowers partners to be a part of the to increased quality and compliance health.’3 process. Now they can offer input, risks. Mitigation of those risks has cost In the UK, the Medicines and contribute data and improve the entire implications, so the initial reduction of Healthcare Products Regulatory Agency operation. Improved access, visibility and direct manufacturing costs through (MHRA) is taking a leading role in the secure control requires an enterprise- outsourcing may be eliminated by raising data integrity discussion and has wide, end-to-end system that’s easily quality’s contribution to the cost of goods provided detailed guidance: ‘With accessible to third parties and that sold (COGS). support from the correct organisational reliably captures data at the point it is But it’s not all about cost. When supply culture, the next important element of generated. chain transparency is limited and quality successful data governance is to With a cloud-based approach, life is compromised, there could be a direct understand the data lifecycle. This will sciences companies can actively control risk to public health and serious enable the implementation of a system, data that goes outside with appropriate consequences for manufacturers. Many which is designed to assure the integrity restrictions on external access. All review supply chain issues are directly or of data throughout its life, beyond the and approval actions are tracked within manufacturing chemist QA/QC

also helps to simplify GxP compliance Benefits can be seen in a very short significantly. period of time, as secure and seamless Another benefit of migrating to the collaboration is enabled once internal cloud is that the access to increased users and external partners are live on visibility in the supply chain will also the system. enable data analysts to spot trends that In a blog post, pharmaceutical IT could lead to even further efficiencies. executive Michael Hughes explained the benefits he saw migrating to a cloud Cloud adoption is a strategic business IT organisation when he was head of IT decision at Kythera Pharmaceuticals: ‘After Once a quality manager decides to years of steadily proliferating on- investigate a cloud-based quality system, premise systems — and the array of what considerations should they keep in hardware and software that comes with mind? them — we’re finally seeing technology The first thing to remember is that move in the opposite direction. In moving to cloud-based solutions is a today’s IT department, the next big business decision, not only an IT thing isn’t the pursuit of more — it’s decision. Cloud-based applications consolidation, harmonisation and provide a new way of making everyone’s shifting to the cloud. The difference in jobs along the chain easier and more efficiency is having a significant impact transparent. The decision to move to a on agility and the bottom line. cloud-based solution requires deep, fact- Standardising on using the cloud has based risk assessment throughout the eliminated the time, expense, and chain and buy-in from key decision hassle of maintaining hardware and makers. User adoption is also a key software in-house.’5 consideration as the staff must be happy Many quality managers may have to use the system, and users will require some initial reservations about cloud- training to make the most of the benefits based technology. But more the system with consistent trails, of using the cloud. organisations see the value and are time stamps and reports. This Security is also a concern. This is rethinking their system landscapes. comprehensive view of data reduces the where the regulated cloud matters When modernising quality management risk of mistakes, harmonising the entire because it means the vendor has systems, cloud technology can be a key ecosystem. designed, built and validated the entire element in fixing underlying issues in We can see how cloud computing hardware and software stack for the sole terms of quality oversight, external addresses Privett and Gonsalvez’s key purpose of providing applications to the collaboration and data integrity. supply chain issues — lack of GxP-regulated industry. There are many co-ordination, management of inventory definitions of cloud computing around, REFERENCE and orders and shipment visibility. The and only a few of them are suitable for 1. Biopharmaceutical Outsourcing Continues to cloud can provide a single source of truth life sciences. Grow, by Agnes Shanley, Pharmaceutical Technology where documents and correspondence When the decision for a cloud solution (April 2016): www.pharmtech.com/ can be stored and easily retrieved, which is made, it can be quickly deployed. dcat-2016-biopharmaceutical-outsourcing- continues-grow. 2. The Top Ten Global Health Supply Chain Issues: Leading regulators Perspectives from the Field, by Natalie Privett and have acknowledged David Gonsalvez: www.sciencedirect.com/science/ that the integrity of article/pii/S2211692314200002. underlying data has become a major root 3. Data Integrity and Compliance with CGMP, cause of quality failure Guidance for the Industry Draft (April 2016): and compliance www.fda.gov/downloads/drugs/guidancecomplianc violations eregulatoryinformation/guidances/ucm495891.pdf. 4. Good Manufacturing Practice (GMP) Data Integrity: A New Look at an Old Topic, Part 1, MHRA blog: 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 Hughes of Kythera Biopharmaceuticals for Veeva Systems’ blog: https://www.veeva.com/life-when-youre-100- cloud/.

CONTACT 4280 Hacienda Drive, Pleasanton CA 94588, USA Tel. +1 925-452-6500 www.veeva.com

manufacturing chemist