Robert Gaertner, senior director of strategy for Veeva Vault Quality looks at the steps manufacturing companies need to take to improve their content management systems.
Life sciences companies with legacy content management systems are facing a multitude of challenges, from inconsistent taxonomies to compliance risks. Quality teams are burdened with complicated requirement definitions, along with configuration and validation processes, when best practices or industry standards are not in place. Irregular naming protocols, patched together systems, and the use of non-validated tools add further complexities. How can organisations harmonise their quality processes and improve the efficiency of their quality content management?
We are already beginning to see a positive shift as more companies adopt modern systems that have built-in best practices and can consolidate GxP and corporate governance. However, even before implementing a new system, companies can transform quality content management with greater alignment, streamlined processes, and improved efficiencies, by modelling practices according to industry standards.
Improved alignment
Organisations often struggle to define a content hierarchy and taxonomy because of the time and cross-departmental resources required for document management. Adopting a reference model with a standardised approach to content management helps quality teams identify gaps in their content landscape, align stakeholders across various business functions, and create a strong foundation for harmonisation across GxP domains.
Using a reference model that provides metadata to allow users to search, navigate, and locate relevant information quickly and easily, improves collaboration with partners, suppliers, and other key stakeholders. Established standards help to align stakeholders more effectively and reduce the effort and complexity in planning and preparation for system implementation.
Streamlined processes
Streamlining long-established, complex processes can be daunting and time-consuming but life sciences companies know it is necessary to achieving lower operational costs and increasing overall productivity and profitability in the long run. To achieve this, companies should focus on three key quality content standards areas:
• Content hierarchy – A standardised hierarchy that organises content by relevant types and subtypes, and associates content with the appropriate lifecycle enables users to easily and quickly access relevant information. Using this approach across the enterprise improves compliance readiness and cross-team collaboration.
• Content types – Grouping content to simplify mapping and minimise redundancies makes it easier for users to search quality content. Organising content into groups such as governance and procedures, operations, forms, and executed records, simplifies structures to streamline quality documents within a system.
• Content lifecycle – Applying lifecycles for content such as, draft to effective, draft to approved, and initial to final, simplifies the process of adhering to industry regulations for quality content management systems, like 21 CFR parts 210 and 211. Establishing standardised workflows for each lifecycle also helps to accelerate reviews and approvals and streamlines Standard Operating Procedures (SOPs) and other GxP content sharing among all stakeholders.
Supply chain efficiencies
The journey through collaboration to sign off can be a long one when there are numerous stakeholders involved in content management. Establishing a standardised approach that is embedded in a modern system will drive efficiency across the supply chain, enhancing collaboration with partners.
The following tips are useful for companies whose quality manufacturing spans many teams and organisations:
• Harmonise processes to enable insights into who made changes to content, what was changed, and why. This level of detail helps to drive better issue resolution when challenges occur. Centralised content management processes also provide greater visibility to stakeholders, allowing for proactive quality management.
• Establish a single source for information to eliminate redundant records and simplify user access to documents, printing, and scanning. This reduces manual and paper-based processes and improves collaboration with partners. Providing stakeholders with secure access to records all in one place increases adherence to GxP practices and protocols.
• Apply automatic checks to keep systems aligned with the established standards and ensure consistency across all global content. Periodic reviews confirm adherence to quality standards and help companies identify and address issues early on, improving compliance and inspection readiness.
Companies that are looking to replace their legacy system with a modern content management solution should consider one that provides access and authentication controls, role-based security and encryption, and enables risk-based strategies. With these capabilities in place, companies can ensure compliance throughout GxP processes. If you choose a cloud system that regularly adds new features and capabilities, ensure that client support and comprehensive change management are offered to speed validation.
Industry standards that advance quality management
Organisations can eliminate inconsistent content management practices inherent within legacy systems, and lower compliance risks by adopting industry standards and best practices. Easy-to-use processes encourage adoption, and standards bring familiarity and a common language for content exchanges with contract partners - relationships that continue to become more critical in the delivery of innovation to patients.
By replacing legacy systems with modern solutions that deliver best practices and quality content standards out-of-the-box, companies are able to move faster and more efficiently and are advancing quality management overall. The implications for the industry are significant – the more companies that apply these standards across their value chains, the faster we will see vital treatments coming to market.