Inspection readiness is now a commercial question
For most of the past two decades, quality documentation sat firmly in the pharmaceutical industry’s "cost of doing business" column. It was essential and heavily scrutinised, but rarely discussed outside the quality function. That is changing, and the change is being driven from two directions at once.
The first is regulatory. The European Commission's proposed revisions to EU GMP Chapter 4 on documentation, consulted on alongside an updated Annex 11 on computerised systems and a new Annex 22 on artificial intelligence, signal a clear direction of travel. Regulators expect data integrity principles, captured in the familiar ALCOA+ framework, to be built into how records are created and maintained every day, rather than assembled when an inspection is announced. Read together, the three documents describe a future in which data, documentation, the systems that manage them, and any applied AI are treated as one connected quality concern.
The second pressure is commercial and, for some global quality and regulatory leaders, it may prove the more consequential of the two.
The sponsor is now an auditor too
Advanced therapy developers rely heavily on external manufacturing partners. Cell and gene therapies, mRNA, and plasmid DNA for viral vector production all demand specialised capabilities that many sponsors choose not to build in-house. That makes the choice of contract development and manufacturing organisation (CDMO) or biotech manufacturing organisation (BMO) one of the highest-stakes decisions in a programme's lifecycle.
When a sponsor evaluates a potential partner, certifications are the starting point, not the finish line. Diligence teams want evidence that documents are current and controlled, that training is complete and traceable, and that the quality system can produce answers on demand. A manufacturer that needs days to assemble evidence from filing cabinets and spreadsheets sends a signal about how it will perform under regulatory inspection, and about how it will respond when a batch deviation needs investigating at speed.
This is where the US ICH Q9(R1) and Q10 become more than reference texts. Both frame quality risk management and the pharmaceutical quality system as proactive disciplines. A manufacturer that can demonstrate that discipline in real time during a sponsor visit is effectively showing its quality maturity, rather than describing it.
For advanced therapy manufacturers, the challenge is scale. It is common for organisations in this space to manage hundreds or thousands of active SOPs, analytical methods, specifications, and quality agreements, each requiring periodic review, redistribution, and verified signatures. Hybrid paper and digital systems, which many organisations have accumulated over years of incremental change, were rarely designed for that volume or for the depth of today's inspections.
Three decisions for QA and RA leaders
Rebuild, don't replicate.
Organisations that simply digitise existing workflows often carry their inefficiencies straight into the new system. Re-examine document architecture, separate modules that have been merged into single SOPs, and redesign processes around good sector practice.
Stage the migration by risk and familiarity.
Document types should move across in sequence: SOPs and analytical methods first, then release specifications, then quality agreements, with further categories added as a team grows comfortable with the system.
Focus validation where the risk actually sits.
Rather than requalifying already-validated core system modules, validation should concentrate on site-specific configuration, such as document numbering conventions and review hierarchies. A risk-based approach mirrors where computerised system validation practice is heading, and it aligns with the risk-proportionate thinking reflected in the proposed Annex 11 update.
Looking ahead: Structured quality data and AI
The proposed Annex 22 deserves particular attention from quality leaders, even those with no near-term AI plans. As the industry explores AI for tasks such as trend analysis, deviation review, and document drafting, the value of those tools will depend on the quality and structure of the underlying data and records. A quality system built on scanned paper and disconnected spreadsheets offers little foundation for responsible and scalable AI use. One built on controlled, traceable, governed data offers a great deal.
The same logic applies to continuous improvement today. When KPIs no longer need to be compiled manually, quality teams can spend that time interrogating the data, spotting trends, and driving process and product improvements. It is one of the most underrated benefits of digital quality, and one that compounds over time.
The strategic takeaway
For QA and RA leaders in advanced therapy manufacturing, the message is that inspection readiness is no longer only a defensive capability. Regulators are raising expectations for how documentation and systems are managed, and sponsors are increasingly using quality maturity to decide where their programmes go.
The organisations moving fastest are not always the largest. They are the ones treating quality transformation as an operating-model decision, rethinking document architecture, validation strategy, and change management, rather than as an IT upgrade. Done deliberately, the result is a quality infrastructure that can withstand greater scrutiny, support growth, and ultimately, help deliver safe and effective therapies to global patient populations.
About the author
With over 20 years of experience leading global teams in quality assurance and regulatory affairs, Mike King, senior director of product and strategy at IQVIA, ensures healthcare solutions meet complex global regulations.
