Rightsizing the Time and Cost of GxP Compliance in Life Sciences

When it comes to compliance, life sciences companies are very similar to Goldilocks.

In the famous children’s fairy tale, the young girl sampled porridge and chairs and beds of the three bears before finding the ones that were “Just right.”

Life sciences companies can address when they face the challenges of complying with federal regulations that require IT systems to operate under the GxP principles, short for “good practice” in a given field (x).

It is clear that life sciences companies can not afford to cut corners regarding compliance with the IT systems listed in the law 21 CFR Part 11A clause in the U.S. Federal Regulations Code (CFR) that requires validation of application, operation, and performance of technology.

But they also do not want to exaggerate. To err on the side of excess in GxP compliance may be time, cost and additional resources to no avail to any stakeholder – life sciences company, regulatory bodies or healthcare consumers. And it shifts the business from its core focus of drug development to prevention and relief of health conditions.

GxP compatibility is the sweet spot, but it can be tricky. This requires deep expertise in the regulatory requirements of 21 CFR Part 11 regulating pharmaceutical, biotechnology and medical device companies. And it requires in-depth knowledge of IT systems. Done right, GxP compatibility contributes to quality and integrity throughout the product life cycle and supply chain.

Zehava only needed a few minutes to find the porridge “exactly”. It may take the life sciences company years of trial and error to develop a “just right” approach to GxP compatibility.

Challenges and risks of IT systems authentication

Some life sciences companies choose to deal with GxP compliance themselves. They invest heavily in internal teams of compliance and IT experts to sort out compliance requirements in enterprise IT systems, with reporting to the US Food and Drug Administration (FDA).

This brings a high overhead of time and cost, plus the challenge of attracting and retaining employees who specialize in GxP compliance and IT systems verification – funds that a company prefers to spend on a molecular biologist, epidemiologist or clinical technician.

GxP compatibility is a complex task applicable to a variety of enterprise systems, from ERP applications and cloud platforms like AWS to software for quality control, production, storage and cloud-based integration such as Boomi AtomSphere platform.

Compatibility becomes even more difficult as IT environments evolve with new cloud applications, software updates and changing business requirements. As systems change, GxP compliance documentation should be shared with the FDA – and be available upon request in the event of an FDA audit.

As I mentioned earlier, life sciences companies certainly do not want to cut corners: non-compliance can lead to severe FDA fines, potential loss of FDA licenses, product returns and unsold inventory. Similar requirements and penalties exist in countries around the world.

Bypass cost and complexity of GxP compatibility

In Jade Global, a Bumi Illit Partner We offer IT services and business consulting, we specialize in assisting life sciences companies Achieve GxP compatibility With Boomi AtomSphere Platform and other enterprise systems.

Our main focus is pre-income start-ups and small to medium-sized life sciences companies with revenues of up to $ 250 million a year, as they often do not have the internal expertise and more mature IT systems that can be seen in larger organizations.

With in-depth experience in both regulatory and IT systems, our team helps life sciences companies circumvent common business challenges surrounding GxP compliance:

Complicated processes- The burden of necessary processes (e.g., regulatory compliance, quality assurance, change management) emphasizes the organization with high overhead and cumulative workloads that can erode the company’s core focus.

Great variability in cost and effort- GxP compatibility costs should ideally be 5 percent or less of the total implementation cost of a new system. However, costs can rise to 25 or 30 percent without the appropriate staff and proven verification processes that are given on their own.

Understanding the “just right” balance between excessive and GxP compatibility is essential. And in the future, this knowledge will support the management of ongoing compliance changes as IT systems and business requirements evolve.

As life science leaders know, GxP is just one of the few compatibility challenges facing the industry. B Previous blog postI described how drug manufacturers should also comply with the FDA’s Drug Supply Chain Security Act (DSCSA), which is designed to combat counterfeit drugs and support returns.

GxP Compatibility for Enterprise iPaaS

So how does GxP authentication and compatibility work? Take the life sciences company that hired Jade Global to implement the Boomi AtomSphere platform for integration between internal and external partner systems.

Customers can choose Jade Global’s pre-built Jumpstart authentication kit, including templates and frameworks, to handle GxP authentication compliance with an internal team. Alternatively, the customer may have Jade Global handle end-to-end authentication processes when Boomi is implemented.

Additionally, companies can choose to manage ongoing changes in GxP authentication as a managed Jade Global service. In this scenario, we provide automated industrial standard IT service management (ITSM) processes and tools for regression testing and verification with the release of Boomi’s cloud updates.

As shown in the diagram below, three main authentication products are designed to ensure that Boomi 1) is installed as specified 2) operates as designed, and 3) operates as specified.

These products are mapped to an authentication methodology based on GAMP 5 (Good Automated Production Procedures Version 5), Widely used in the life sciences as a risk-based approach to GxP-supervised computerized systems. Some verification steps include developing:

  • Comprehensive authentication program
  • User requirements and functional risk assessment
  • Functional and technical design specifications
  • Protocols and Reports for Installation Certification (IQ), Operational Certification (OQ) and Performance Certification (PQ)
  • Tracking matrix and validation summary
  • Training materials and work training

Finally, the life sciences company is gaining continued visibility regarding GxP compatibility status. Deviations that would be difficult to manually identify are highlighted for quick investigation and resolution, eliminating potential obstacles that could disrupt compliance and organizational focus.

A holistic approach to leading life sciences goals

GxP compliance is not an easy task, but it is much simpler for organizations that create a unified enterprise ecosystem anchored by the best in the class. Service Integration Platform (iPaaS).

At Jade Global, the Boomi AtomSphere platform is our preferred iPaaS to help life sciences companies accelerate their IT cloud modernization efforts and wider digital transformation. As I mentioned in an Previous blog postEssential integration for digital transformation systems integration.

A holistic approach prepares a life sciences startup or medium-sized company to orchestra, under one umbrella, three focus areas that help in short-term success and long-term prosperity:

  • Digital transformation with a unified enterprise ecosystem
  • DSCSA requirement tracking and tracking for end-to-end visibility of the supply chain
  • GxP compliant IT systems that meet 21 CFR Part 11 requirements

By tailoring these three initiatives, the company gains speed and agility to achieve top-level goals of faster market arrival time and improved operational efficiency while opening up data for analysis and informed decisions.

With increased attention to the life sciences following COVID-19, we are already seeing a distinction between companies working ahead with solid antique systems versus those committed to digital transformation in a modern IT environment that meets regulatory requirements. This gap will only increase in the coming months and years.

About the writer

BK Srinivas, Vice President, Enterprise CloudApps

BK Srinivas is a senior vice president, enterprise cloud applications, at Boomi Elite Partner Jade Global. BK has over 30 years of experience in the IT services industry, with expertise in areas including life sciences, global ERP, process automation, organizational integration and supply chain management.

Rightsizing the Time and Cost of GxP Compliance in Life Sciences Source link Rightsizing the Time and Cost of GxP Compliance in Life Sciences

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