How Technology Has Changed Regulatory Compliance in the Past Decade

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We Share ACommon PathLife science companies, regulatory bodies, and technology providers share a common path—a highway, if you will, where science and technology merge in order to deliver medical solutions to the world. The on-ramp where the two merge is regulatory compliance. Without compliance, there can be no product approval, and no matter how cutting-edge your device or medicine, it won’t reach the people who need them.

You’re Part Of A Movement

Do you work in the life science industry or a regulated environment or the compliance technology sector? If you answered yes, then you’re part of a technology-driven movement delivering life-changing products to patients and consumers worldwide. Let’s take a look at this movement.

Learn,Adapt and ImproveThis presentation is based on Matthew M. Lowe’s book about how technology in the past decade has advanced regulatory compliance like never before. He offers insights on the industry and some forecasts to help you learn, adapt, and improve.

Read the book for free:Convergence of Compliance andTechnology: How Technology Has Changed Regulatory Compliance in the Past Decade

ManualProcessTo appreciate how technology revolutionized compliance, take a look at the manual process in a med device firm (in a nutshell). Imagine doing this with thousands of drawings.

• To change a drawing, get a change order number

• Incorporate all redlines in the drawing

• Print a paper copy of new drawing

• Get it stamped • Submit it to doc control, then it

goes through approval process

MovementTowardAutomationRegulations impose a heavy documentation burden, especially with a manual process. Such hardship pushed life science companies to automate quality and compliance processes and regulatory submissions. This movement toward automation led to the development of 21 CFR Part 11.

What Is 21 CFR Part 11?

This watershed regulation established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the U.S. FDA. 21 CFR Part 11 went into effect in August 1997. It took two guidances (in 2001 and 2003) to explain the regulation’s scope and application.

How Part 11 Became A Big DealAlthough the FDA’s Part 11 guidance is nonbinding, it’s not a license to ignore the regulation. Does Part 11 have any teeth? Yes, judging by the hefty fines Abbott Laboratories and Schering-Plough paid due to a host of CGMP violations, including requirements related to Part 11.

Milestones

Since 2000, we have benefited from a technology-driven era in regulatory compliance. Ours is a time of faster and more effective regulatory submissions and adverse-event reporting. Matthew Lowe’s book identifies 16 laws and initiatives that helped shape the rapid modernization of regulatory compliance.

Regulators’ExpectationsGiven the wider use of electronic systems in life science companies today, regulators increasingly expect automation in a QMS. In some cases, like with the eMDR and eCTD, it is even mandated.

Software Industry’s Response

In response to an increased demand for quality and compliance software solutions, providers have tailored their offerings to specific requirements and standards. Software products are evolving to connect more and more business processes and remain current with changing regulations.

The FutureStarts NowIn life sciences, time is of essence. Product development requires tremendous investment in time, money, and effort. It takes more than a decade to develop a new medicine and get it approved at a cost of about $2.558 billion, according to the Tufts Center for the Study of Drug Development. You simply can’t afford any delays.

Need ForSmarterComplianceMatthew Lowe says compliance will get “smarter” as technology takes a greater role. Regulators will also introduce more and more technology-facilitated standards and regulations. He expects greater interaction among industry, regulators, and technology vendors.

How BestTo PrepareLife science companies should prepare for an even more technology-driven regulatory landscape in the future. Leverage technology and develop a forward-looking orientation within your organization through these steps:

1. Develop a cross-functional approach.

2. Bridge the gap between the quality team and the rest of your organization.

3. Make your processes transparent.

4. Increase your inspection readiness.

5. Increase your competitiveness by focusing on your core competency instead of routine.

To understand technology’s impact on life science companies and regulatory compliance, read this enhanced e-book for free:

CONVERGENCE OF COMPLIANCE AND TECHNOLOGYHow Technology Has Changed Regulatory Compliance in the Past Decade