Vasishtha Chittaranjan Mehta

Director

Pharmaceutical companies are racing to digitalise, but in a regulated industry, moving faster cannot mean compromising control. As cloud platforms, AI-led ap­plications, manufacturing execution systems, automation and connected quality environments reshape how medicines are developed and manufactured, every technological ad­vance brings an equally important compliance question.

For regulated organisations, adopting technology is only half the challenge. The harder task is ensuring that every new system remains aligned with GxP requirements, data integrity ex­pectations and validation principles throughout its lifecycle.

Anthem GxP Solutions is positioning itself at this intersection of technology and compliance. Having built its foundation around Computer System Validation (CSV), the company has expanded its scope considerably over the past year, moving into design, development, implementation, assurance and automation.

The shift reflects a larger strategic ambition: to become involved earlier in the technology lifecycle rather than entering only when a system is ready for validation.

The company has also moved into a larger facility, expanded its team and brought in professionals with core software-development capabilities. In parallel, it has established a separate automation-focused entity and is developing products for GMP and GxP environments, particularly around smaller pharmaceutical applications.

At the centre of this transition is Anthem GxP Solutions’ leadership philosophy that automation cannot be separated from process understanding. Its approach is shaped by deep experience in automation and control, combined with an emphasis on understanding pharmaceutical regulations, manufacturing processes and system behaviour before technology is implemented.

From Validation Specialist to Lifecycle Partner

For years, Anthem GxP Solutions remained sharply focused on CSV, building its reputation around validation activities across pharmaceutical systems. Over time, however, the com­pany identified a recurring problem: by the time a system reached the validation stage, weaknesses in requirements or system design had often already become embedded. That in­sight prompted the firm to move upstream.

“The company now seeks involvement from the stage where requirements are being defined, allowing it to influence how systems are designed and implemented before validation begins. This approach is particularly relevant for enterprise platforms, where unclear requirements, gaps between users and developers, or poorly interpreted regulatory needs can lead to expensive corrections later”, speaks Vasishtha Mehta, Director.

A recent Document Management System engagement illustrates the model. Anthem GxP Solutions helped define the specifications, guided the development team on system behaviour and supported the rollout of a SharePoint-based solution incorporating electronic-signature requirements.

The value proposition is therefore changing from simply asking whether a system is compliant to helping ensure it is designed for compliance from the beginning.

Building Technology Around Pharmaceutical Operations

Anthem GxP Solutions’ expansion is also visible in its internal technology capabilities. One of its key developments is Atlas, an in-house operational and project-tracking platform designed to provide granular visibility across validation and implementation projects.

Pharmaceutical technology projects often involve hun­dreds of documents, multiple review stages and dependencies across client teams. Atlas breaks these activities into smaller, trackable stages, allowing the company to identify whether a delay is caused by technical issues, resource availability, cli­ent inputs, pending SOPs or documentation bottlenecks.

Im­portantly, the firm follows a philosophy of becoming the first user of the systems it develops. By implementing and testing technology internally before taking it to clients, the company aims to understand practical limitations rather than relying only on theoretical design.

This internal-first approach is also shaping its response to cloud, AI and ML adoption. Anthem GxP Solutions began evaluating these technologies years before they became dominant industry conversations and had already undertaken an AI/ML-based pharmaceutical reporting project in 2023. This early preparedness is allowing the company to approach newer technologies with a compliance framework already in mind.

Where Technology Meets Regulation

As life-sciences companies accelerate automation, Anthem GxP Solutions sees one of the biggest risks emerging from the disconnect between technological ambition and operational reality. Senior management may push for highly automated, AI-enabled systems, while manufacturing teams, quality func­tions, IT departments and implementation partners may in­terpret the same project differently.

It therefore places stake­holder alignment at the centre of its methodology. Its teams are encouraged to understand pharmaceutical processes before approaching automation. Knowledge of requirements such as US FDA 21 CFR Parts 210 and 211, EU GMP principles and ICH guidelines as well as deep understanding of US FDA 21 CFR part 11, EudraLex Vol 4 Annex 11 and the Data Integrity Guidelines, are viewed as essential, not supplementary.

Anthem GxP Solutions believes companies will therefore need stronger cross-functional communication, clearer technology governance and validation strategies capable of accommodating new development models without compromising traceability or compliance.

Preparing for the Next Stage of Pharma Automation

Anthem GxP Solutions’ long-term roadmap extends well beyond conventional validation services. Over the next three to five years, the company expects pharmaceutical operations to see deeper adoption of AI-led automation, robotics and integrated manufacturing technologies as these systems become more economically accessible.

Its strategy is to build capability across software, PLC, DCS, MES and broader factory automation while gradually moving toward hardware-based manufacturing as well.

“At the same time, we recognise that complete factory automation will not be economically viable for every pharmaceutical organisation. Its future offering is therefore intended to cover both ends of the spectrum - from integrated automation environments to focused solutions for individual areas such as dispensing or specific manufacturing processes”, shares Vasishtha Mehta.

The broader ambition is clear: to evolve from a validation specialist into a comprehensive pharmaceutical technology and compliance partner. As digital systems become more in­terconnected and regulatory expectations continue to evolve, Anthem GxP Solutions is building its next phase around a sim­ple premise - technology delivers sustainable value only when operational understanding, implementation discipline and compliance move together.