Robert Gaertner, director, Europe strategy at Veeva Systems on the search and rescue mission for data integrity
At Sea
Inspection findings and warning letters related to externalised manufacturing operations continue to be a major risk, according to the most recent statistics. Data integrity has been continuously ranked as one of the major root causes. Leading authorities such as the MHRA and FDA have responded by publishing draft guidance on this topic to help life sciences companies ensure data is consistent and accurate. Data integrity is crucial to ensuring the safety, efficacy, and quality of drugs. And, as outsourcing continues with more critical manufacturing functions performed outside the company − and outside of direct oversight – ensuring data integrity is increasingly difficult.
As data integrity issues continue to surface during plant inspections, regulatory authorities are trying to compel manufacturers to clean up data operations. In fact, business and production-control systems that were formerly only given cursory reviews have come under increasing scrutiny. With the absence of credible data, the concern is that these companies’ products cannot be trusted.
Quality processes now span internal and external parties; however, many supporting systems were designed to operate only within a company’s walls. In addition, many of these applications do not work well together, often existing in siloes. Significant manual overhead is necessary to bridge the gap between all parties and among applications to stitch together a continuous process, which then creates many opportunities for data issues.
Having the quality team review the data from manufacturing sites is a great first step. However, communication still often occurs via email, or some other uncontrolled method, in a non-validated environment. This could lead to an observation or warning letter.
Using secure, cloud-based technology that is purpose built for the GxP area will support the end-to-end lifecycle management from drug development to commercial manufacturing, regardless of whether operations are internal or external. Every move is controlled and can be subject to oversight, reducing the risk of data being manipulated or lost amid fragmented processes and disparate systems.
The GxP-regulated cloud gives life sciences companies the ability to extend data integrity across all parts of the value chain, while at the same time enabling partners to access information they need. Raw-materials suppliers, contract research organisations (CROs), contract manufacturing organisations (CMOs), brokers, and distributors can interact simultaneously under very controlled conditions to ensure that accurate, up-to-date information is always available to those that need it – whenever, wherever, however.
Reviewing information from manufacturing sites helps detect data integrity issues; however, problems are typically more difficult to detect and have greater impact near the end of a process. Moving upstream and providing the quality team with direct access to the quality management system allows issues to be detected earlier and accelerates downstream decision-making. The quality team can review process deviations, so problems can be resolved proactively and approvals can be streamlined for improved efficiency. Providing all stakeholders with access to up-to-date, accurate data and content in a single, authoritative system instills greater confidence that operations are being executed compliantly.
There’s no question that the industry will continue to increase its outsourcing of critical manufacturing functions. This shift has greatly disrupted how quality is maintained. Manual processes backed by siloed legacy technology do not make it easy to extend visibility or process control outside of the organisation. This can result in a number of large-scale quality issues and attract regulatory scrutiny globally.
Establish a cloud technology foundation to transform manufacturing and quality management – and do more than just make incremental steps forward. Industry cloud solutions that manage quality content and processes bring together all stakeholders on one platform – ensuring an auditable trail of all activities with partners.