Five Strategic Ways to Achieve Operational Excellence Through Quality Management – A Pharmaceutical Take
For more than 12 years, I’ve helped global pharmaceutical companies achieve operational excellence across their manufacturing and distribution processes through software. By achieving this, I’ve seen companies ensure safe, compliant and competitive products are available in a timely manner for patients.
Elevated standards of operations are becoming increasingly important as the pharmaceutical and life sciences industry digitally ramps up. Online regulatory audits are becoming more common — particularly since -COVID-19 began — and the industry is increasingly relying on digitization to ensure compliance and efficient systems and processes, especially when in-person connections are not possible. In 2021, I anticipate we’ll also see increased assessment, diagnosis and treatment of patients online across the Asia Pacific region and globally. More than ever, this will require secure and reliable systems, processes and data.
Additionally, businesses are looking to create efficiencies and reduce costs by removing manual processes and eliminating wet signatures, and, in my experience, the right technology can support them to achieve these goals through end-to-end quality management, increased collaboration, visibility and control, and unification of data and systems.
Working closely with companies over many years, I’ve identified five strategic ways that businesses across the life sciences industry can achieve operational excellence with an overall focus on quality management. Veeva supports our customers with all five functions.
- Manage quality processes
To ensure quality processes across the entire operational lifecycle, from manufacturing through to distribution, regulated content and data must be managed across the organization and with partners. This includes creating best-practice processes for deviations, internal and external audits, CAPAs, complaints, lab investigations and change controls with integrated risk management. These processes can be automated with technology through workflows, appropriate allocation of resources, detailed audit trails, interactive dashboards, and reports. It is more important than ever to manage quality processes in our globalized society, with reliance on quality for major cold chain products such as the COVID-19 vaccines. For example, the Australian vaccine is being transported from Europe and the US and there are many challenges, from storage at minus 70 degrees Celsius, through the air and overland, that need to be monitored for quality along the way so that the vaccine remains ready for use upon arrival. Logistics experts say these challenges are “massive” and “unprecedented”. This level of logistics coordination is possible with the right technology to ensure quality along the journey.
- Increase collaboration
There are many stakeholders involved in the end-to-end lifecycle of developing and bringing products to market. These might include suppliers, internal stakeholders, contract manufacturers, and customers. All parties will achieve greater visibility and control by collaborating in a single authoritative source for quality documents and data. The right technology supports all partnership models, aligning global quality processes for greater automation and operational effectiveness, as well as reducing email traffic.
- Ensure full visibility and control over business processes
Relying on a single source of truth across the enterprise provides complete visibility and control over quality business processes, from product development to commercialization.
Secure cloud-based software can provide a unified platform which easily and securely allows suppliers, contract manufacturers, and other partners to collaborate for greater control and visibility into quality outcomes. The right software will also ensure timely availability of medicine to patients and avoidance of fines from health regulators for critical medicines shortage.
- Create unified and connected business processes
Across the operational lifecycle, business processes should ideally be unified and connected so workflows can become more automated, saving time and money. Additionally, greater visibility into content status and processes enables effective standard operating procedure (SOP) management, reducing compliance risk and reducing cycle times.
The best technology provides a unified suite of quality systems to streamline cross-functional business processes on a single cloud platform.
- Use secure systems for data and storage
Two of the biggest considerations for the life sciences industry when it comes to adopting cloud-based software is security and accessibility for compliance. Across the lifecycle of development, manufacturing, distribution and beyond, regulatory and compliance requirements must be adhered to. This means documents must be held securely but be accessible any time, from anywhere. For example, if a product is recalled, batch documentation must be kept for at least a year post shelf life. Another example is critical documentation which supports information in the Marketing Authorisation process should be retained while the authorisation remains in force. Cloud-based software is the most reliable and efficient system to keep and retrieve this type of information — particularly over this length of time — and self-management reduces dependencies on external archival systems.
At Veeva, data security is paramount both internally and for our customers. Veeva protects customer data with world-class physical, network, application, and data-level security. In addition, Veeva invests in the most advanced and modern infrastructure available to provide an innovative, scalable, global, predictable, and secure environment.
To find out more about Veeva Vault Quality Suite, and how this suite of products can support your business, please contact us via this link.
April 2021
Veeva Systems
Solution Consultant & CSM
Anuradha Ramesh