Connecting Quality and Regulatory for Data-Driven Change Control

May 06, 2025 | Vicki Cookson and Sophia Lange

Data-driven change control enables greater automation for efficient processes and provides a more comprehensive view into regulatory and product impact for better decision-making.

Although change control processes span quality and regulatory, the underlying systems are usually siloed. Typically, these functions overcome barriers by following manual processes to complete their work and communicate. This friction makes it more difficult to exchange documents and data, agree upon a single set of product information, manage variations, or collaborate with external partners.

A single platform across quality and regulatory enables all stakeholders to see the same regulatory and product information, making it easier to assess regions and documents affected during a post-approval manufacturing change. In addition, if a regulatory event occurs affecting multiple markets, quality change controls trigger automatically. Health Authority (HA) filings are tracked in real time, ensuring quality teams are notified as soon as approvals are received. Since data is consistent between functions, it can be exchanged automatically, which saves time. This real-time access to information reduces the risk of downstream product distribution delays.

Three biopharmas and a contract development manufacturing organization (CDMO) explain key considerations when bringing quality and regulatory closer together for faster time to market.

Greater connectivity drives value

When a manufacturing process or specification changes, regulatory teams need visibility into affected countries and internal documents, while supply chain teams require individual product information. Fragmented data and highly manual processes across production, quality, and regulatory functions create bottlenecks while coordinating activities. This slows change control and delays batch release.

Companies typically contend with thousands of changes annually across their global portfolios. Planning and processing each change can take six months to two years because of data silos and limited integration between QMS, LIMS, RIM, and ERP. Disconnected systems result in inconsistent definitions between functions and duplicate data, increasing the risk of errors.

A quality-to-RIM system connection streamlines change control efficiency by improving cross-functional collaboration and limiting rework [Figure 1].

Figure 1: Connected quality and RIM speeds up batch release

UCB found managing variations unsustainable across thousands of annual post-approval changes. Since connecting Veeva Quality to Veeva RIM, release decisions are informed by the two-way data exchange between these functions. “With this connection, we’ll have real-time visibility into global variation approvals and each step of the end-to-end change control process, from regulatory to manufacturing to packaging,” said its associate director and digital quality partner.

Centralizing access to data and documents in a unified platform also enhances external collaboration between biopharmas and their partners. For example, Karyopharm Therapeutics, a company primarily focused on developing novel drugs for cancer, uses Veeva QualityDocs to streamline supplier collaboration. Vendors can upload quality and regulatory documents directly into the sponsor’s document management system (DMS), eliminating manual data entry and verification and saving many rounds of emails.

When different functions and authorities can efficiently exchange the latest data, the results are greater decision confidence and faster delivery of medicines to patients. As an associate director of regulatory and clinical platforms at a global biopharma explained, “After connecting Veeva QMS and Veeva RIM, the data and information required for change control doesn’t have to be requested or sit in someone’s inbox for two days. This has significantly reduced the time required to perform regional impact assessments and send that information on to supply chain and quality departments.”

Start by making the business case

Making a strong business case for connecting quality and regulatory means highlighting outcomes that matter to senior leadership, such as faster cycle times, reduced regulatory risk, fewer inventory management issues, and expedited product distribution. Key performance indicators (KPIs) that track and measure operational improvements and efficiency gains are more likely to resonate with decision-makers than, for example, a better user experience.

When mAbxience, a biotech that develops and manufactures biologics, wanted to transition from paper-based regulatory processes, it highlighted the positive impact of a digital solution on data visibility and sharing, as well as team productivity. Alberto Quesada, regulatory affairs associate at mAbxience, compares the transformation to “moving from your old mobile to a smartphone. You go from having a telephone in your hands to a computer.”

Prepare the organization for change

Once the business case for change is approved, effective adoption hinges on educating end-users on key benefits. Real-time information flow between cross-functional teams will reduce the risk of errors as teams are always working from the same up-to-date documents.

For mAbxience, this meant communicating that better data visibility would help users complete core tasks, such as reporting, more quickly and easily.

Transparent, ongoing dialogue is critical if end-users come from different starting points. For example, CDMO Recipharm had distinct quality systems at its 14+ worldwide manufacturing sites. It piloted the transition to a unified quality solution with a group of sites representing varying sizes and levels of digital maturity. During regular meetings, the Recipharm Center of Excellence listened to site concerns and addressed feedback. User adoption data provided helpful context, explains Recipharm’s Paula Cuesta Urquía: “Not every site will adopt new technology immediately, so you need metrics at the site level that can be tracked over time.”

It’s worth considering whether your organization has sufficient in-house expertise. Partner support can be instrumental to success while preparing, planning, and implementing new solutions. As Paula Cuesta Urquía points out, “Even getting the documentation ready could take too long.” The CDMO accelerated its overall project timelines by working with external consultants ahead of the ‘big bang’ implementation of Veeva QualityDocs, Training, and LearnGxP across all sites, and its ongoing transition to Veeva QMS.

Gain a competitive advantage with a data-centric approach

Connecting quality to RIM systems streamlines change control management, elevating compliance and leading to faster cycle times. It also creates a common framework for sharing core product data.

After integrating their quality and RIM systems, companies can apply advanced analytics to their data. Consistent, high-quality data is foundational for powering AI use cases: Recipharm, for instance, is preparing a structured and standardized database for its sites so that it can be used with AI proof of concepts.

As one quality leader notes, better connectivity could sharpen a competitive edge with actionable intelligence: “We want to understand how to use data intelligently between logistics, regulatory, and quality. That end-to-end flow will help us make decisions and give us vital feedback for R&D.”

Learn more about the Veeva Quality to RIM connection.