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April 19, 2016

Taking off from my previous post on how compliance involuntarily promotes a culture of inhibition, this post explores ideas and invites suggestions on how pharma companies can overcome inertia and strike the right balance between compliance, and emerging digital technologies.

Business affinity towards digital is well known. But in pharma, digital goes beyond mere enterprise implementation. It impacts end-customer (patient) experience. The healthcare ecosystem, comprising payers, providers, physicians, and distributors, is working towards better patient engagement through digital technologies. In all this, pharmas role is multi-dimensional. The expectation from pharma is to move beyond the pill, and deliver better provider engagement, improve patient experience, enhance clinical outcomes, and most importantly, reduce the total cost of care. Merely digitizing internal functions or interfacing with patients through digital technologies wont help.

Meeting the multi-dimensional expectation calls for newer QA, comprising innovative methodologies, processes, tools, and frameworks. QA organizations must balance regulation, compliance, methodologies, and technology, within IT functions. Here are a few, non-prescriptive solutions to strike that balance.

To begin with, pharma companies must harmonize their Quality Management System (QMS), and yet have a differentiated approach to validating GxP and non-GxP systems. Characterized by a mix of organic and inorganic (merger and/or acquisition) growth, even global pharma companies do not yet have global, consistent, and simplified QMS processes across regions. The inconsistency results in confusion among IT stakeholders working on global projects, particularly those based on lean, agile methodologies, and not the traditional validation lifecycle. A global, integrated QMS helps clear confusion around gray areas such as SOP adoption, roles, and responsibilities.

Most SOPs revolve around the normal validation lifecycle (GAMP V-Model) approach, without exploring augmentation options for agile, cloud, or mobile adoption. It may be time to change, and adopt FDA regulations on mobility. Pharma applications not mandated by GxP could follow a differentiated testing approach, giving project teams the much-desired flexibility to adopt newer methodologies, tools and frameworks, while still being accountable for overall product quality.

Suppliers too, must avoid cookie-cutter solution approaches, and demonstrate their appreciation of compliance through pre-validated solutions compliant with pharma regulations. Looking from the QA heads perspective, with the compliance sword dangling overhead, disrupting status quo is easier said than done. The change must be mutual. Its not really difficult, if suppliers are sensitized and conscious of the need to provide evidence of solution functionality meeting intended requirements. All it takes is effective internal audit controls at the supplier end.

IT security and quality go hand-in-hand for pharma. Proper understanding of regulations related to electronic signatures and records helps develop right-fit, customized solutions that easily fit into pharmas compliance framework.

Finally, diligent documentation is at the heart of the pharma quality function. While traditional approaches have known to produce volumes of documentation, Agile and lean methodologies focus on eliminating waste and adding value through continuous feedback and minimal documentation. Before pharma businesses can even think of embracing Digital, this dichotomy sets in. QA organizations, through risk assessment and evaluation, must help reconcile this dichotomy, facilitate selection of middle paths, and prove that Agiles differentiated approach to documentation, in no way, reduces its applicability in pharma. Agile can be equally effective in pharma too.

These are just a few suggestions. When we reflect about our roles, we will discover many more ways of striking the right balance between risk management and compliance. There are still some challenges that must be addressed for instance I havent touched upon the world of Open Source models and that will require long debate.As I complete this pharma blog series, I would like to hear from the practitioners too. Put on your thinking caps, and fill the comment box with your insights, thoughts, suggestions, and experiences.

Satya is a Quality Assurance Consultant at TCS' Assurance Services Unit. He has handled various roles including IT Program Management, IT Delivery Management, Consulting and Business Development. Over the years he has helped customers, across the major markets, to set up Test Models and develop an Assurance Strategy for Large Programs. He is passionate about the world of Quality, Design, Art and Pharma. He holds a Post Graduate Program in Management from Great Lakes Institute of Management, Chennai.


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