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Insights to guide your digital transformation.


The Future of Traceability in FDA-Regulated Manufacturing

Oct 24, 2018 8:29:58 AM

As new technologies are introduced, how will expectations for tracking change for FDA-regulated manufacturers?

 A shift is happening among manufacturers in FDA-regulated industries. The popularity of generics, direct-to-consumer business models and the recent explosion of SKUs has brought new pressures to biotech developers, laying out new expectations for manufacturers. What was once a transactional relationship is becoming a more collaborative one, as developers and manufacturers partner together to obtain an edge in an increasingly competitive and complex supply chain.

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Why ERP System Validation is Important for FDA-Regulated Manufacturers

Oct 10, 2018 10:34:07 AM

What are the consequences of a faulty software validation, and what do manufacturers stand to gain in verifying their ERP system?

For a manufacturer in a regulated industry, such as a medical device or pharmaceutical firm, compliance is a responsibility that permeates through all facets of your business, including the software you use in your manufacturing processes. A critical step in implementing your ERP system is validating that the software meets business requirements in accordance with FDA regulations. Many of these specifications are detailed in the US Code of Federal Regulations (CFR) Title 21, including GMPs and Quality System Management principles that must be followed. However, compliance is more than just “ticking boxes.” Early attention to software validation can benefit your company in the long run. Here’s how.

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3 Ways Your ERP Implementation Could Go Wrong: What Life Sciences Companies Need to Know

Sep 26, 2018 9:07:14 AM

With resources, capital and compliance on the line, how can you effectively manage risk during ERP deployment?

When you’re a small or midsize business in an FDA-regulated industry, implementing a new software can introduce a significant amount of risk. You’re dedicating a substantial portion of your annual budget to a system that will transform how you do business. This transformation is where the return on your investment lies, but to make it happen, you’ll need to manage your time, your resources and your budget – all while maintaining your compliance obligations. What could go wrong? Here are three scenarios to look out for during your ERP implementation – and how to get ahead of them.

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Tailoring Cloud ERP for Your Early-Stage Life Sciences Company

Sep 11, 2018 11:14:00 AM

How to confidently meet your regulatory obligations in a cloud-based environment.

Over the last few years, cloud-based ERP has become an increasingly popular option for manufacturers across industries. In contrast to an on-premise ERP solution, cloud ERP offers distinct advantages – most notably, easy online accessibility for employees who are away from the office. Deployment options for cloud ERP range from public, multi-tenant options to private, single-tenant clouds to hybrid models that lie somewhere in between. There is no one-size-fits-all solution, but as a life sciences company, you have regulations and compliance concerns to take into consideration. Below are some decisions you will need to make as you consider adopting a cloud-based ERP solution.

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Right-Sizing Your ERP Solution as a Life Sciences Startup

Aug 28, 2018 9:42:02 AM

How to select an ERP system that will help you safely scale-up in an FDA-regulated industry

Startups in any industry must master the skill of achieving short-term scale-ups without losing sight of their ultimate goal. For life and small and midsize businesses (SMBs) in the sciences startups industry, the long-term target may be FDA approval, sustained profitability or acquisition.

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ERP for SMB, Part 5: Verifying Your Growth Strategy

Aug 13, 2018 9:42:45 AM

In this special blog series, ERP for Small and Midsize Manufacturers, we’ll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you’ll learn what to look for to extend the value and shelf life of your next ERP system.

When your focus turns to growth as a small or midsize manufacturer, one of your first priorities is mitigating risk. We’ve already discussed how an ERP system can help strengthen your operations and keep your organization nimble when experiencing market shakeups. But how can ERP help SMB manufacturers prepare for a business shift they’re initiating themselves?

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ERP for SMB, Part 4: Making Confident Business Decisions with Real-Time Data

Jul 30, 2018 2:14:28 PM

In this special blog series, ERP for Small and Midsize Manufacturers, we’ll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you’ll learn what to look for to extend the value and shelf life of your next ERP system.

As an SMB manufacturer, you probably have deep expertise in your particular niche. You are well-versed with your market and know where you fit into the mix. Likewise, you know your company, its strengths and its weaknesses.

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ERP for SMB, Part 3: Working Smarter with Automated Workflows

Jul 16, 2018 4:16:49 PM

In this special blog series, ERP for Small and Midsize Manufacturers, we'll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you'll learn what to look for to extend the value and shelf life of your next ERP system.

The priorities of SMB manufacturers differ from industry to industry. The requirements for a medical device manufacturer will be very different from those of a custom shipbuilder.

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ERP for SMB, Part 2: Meeting Evolving Business Needs with Modular ERP

Jul 9, 2018 10:53:46 AM

In this special blog series, ERP for Small and Midsize Manufacturers, we’ll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you’ll learn what to look for to extend the value and shelf life of your next ERP system.

Small and medium-sized businesses (SMBs) must often make forward-thinking investments to reach the next phase of growth.

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ERP for SMB, Part 1: Staying Nimble with Cloud-Based ERP

Jun 22, 2018 9:43:17 AM

In this special blog series, ERP for Small and Midsize Manufacturers, we’ll discuss how SMBs are gaining an edge in the Manufacturing industry through ERP software. From flexible deployment options to mission-critical functionality, you’ll learn what to look for to extend the value and shelf life of your next ERP system.

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ERP Software & FDA Compliance, Part 6: The Benefits of an Integrated Quality Control Solution (QCS)

May 14, 2018 2:11:55 PM

In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

From managing suppliers to delivering on your customer’s expectations, quality is a responsibility that is fulfilled by everyone at your organization, whether they realize it or not.

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ERP Software & FDA Compliance, Part 4: Approved Supplier Management

Apr 30, 2018 3:33:19 PM

In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

It is not uncommon for manufacturers in FDA-regulated industries to utilize suppliers for components of their finished products.

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ERP Software & FDA Compliance, Part 3: Obtaining Digital Approval with eSignatures

Apr 23, 2018 2:05:19 PM

In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

It used to be that manufacturers in FDA-regulated industries could get by handling approvals the old-fashioned way – with a stack of papers awaiting signature in an executive’s office.

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ERP Software & FDA Compliance, Part 2: Full Lot & Serial Tracking

Apr 9, 2018 3:23:54 PM

In this special blog series, ERP Software & FDA Compliance, we’ll discuss the advantages of using an ERP system in an FDA-regulated industry. From organizing mission-critical documents to vendor management, you’ll learn how ERP helps keep product timelines in place and manufacturers in compliance.

From food and beverage to medical device, manufacturers in FDA-regulated industries have a critical responsibility to maintain end-to-end lot and serial number tracking and management.

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Digital Transformation & the Evolving Role of ERP, Part 6: How the Internet of Things (IoT) Is Transforming the World of Manufacturing

Apr 3, 2018 10:46:42 AM

In this special blog series, Digital Transformation & the Evolving Role of ERP, we’ll discuss ERP’s new place at the heart of Manufacturing’s digital transformation. From business analytics to artificial intelligence and the Internet of things (IoT), you’ll learn about the cutting-edge technologies disrupting how manufacturers do business.
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