The medical device manufacturer that had a spectacular compliance failure probably made the headlines. Their story will be noted in university classes around the world for years to come. Let’s look at another outcome.
Pharmaceutical, biotech, medical device and other life sciences companies are under increasing pressure to succeed in a highly competitive and regulated marketplace. There is no room for error, especially when delivering life-changing products to customers. An integrated business platform for ERP, CRM and BI can optimize operations, support all phases of growth and deliver the very data needed to succeed.
There is so much to consider during an ERP implementation, isn’t compliance something that can be attacked once everything else is in place? Compliance is a combination of people, processes, and software. Since these same components are part of a successful ERP implementation, it just makes sense to consider both at the same time. A good implementation focuses on more than just installing hardware and software; it considers how that software will complement the way things get done. And keeping track of how things get done (and making sure these processes meet internal and external expectations) is the dominion of compliance.
(You are on our Microsoft Dynamics GP Advanced Lot Management Page. If you are interested in Enterprise ERP and Lot Management solutions – check out our Microsoft Dynamics AX Page for more information.)
Expand your ability to operate efficiently while controlling restricted materials within Microsoft Dynamics GP Manufacturing. Increase operating control, track all lot information completely, and automatically maintain compliance with FDA requirements.
Impose material use limits through Expiration Date field.
Control Lot Status with the addition of four status assignments: Hold, Approved, Quarantined and Rejected.
Manage lot transactions by only allowing use of approved materials in manufacturing and distribution.
Enforce rules for specific data choices and tolerances for lot characteristics.
Track Lot Information – Completely
Track lot information in key stages of inventory processing such as Manufacturing Order Receipt and Inventory Adjustments.
Works with Dynamics GP Inventory—Sales Order, Purchasing Order and Manufacturing Order Processing.
Maintain Compliance – Automatically
Advanced Lot Management is configurable to support your company-specific process and compliance rules.
Used with the Risk Management Suite, Advanced Lot Management operates in accordance with the requirements of FDA 21 CFR Part 11.
Contact Merit Solutions for more information on Advanced Lot Management.
Managing validation document lifecycles and deliverables can be error-prone and time-consuming. Which leads to the question: "Can paperless validation be a reality?"
Join us for our Green Validation Webinar on Tuesday, February 24th, at 12:00pm Eastern (9:00am Pacific) as Valarie King-Bailey, CEO of OnShore Technology Group, discusses effectively managing validation processes and documentation in a consistent and green manner.
This session will cover the following topics regarding ERP validation:
Learn how to ensure compliance, streamline validation, and reduce costs by registering now for this webinar!
And then take a look at the other upcoming sessions we have in our Mastering Compliance and Innovation Life Sciences Webinar Series.
Quality compliance is never a static concern. With changes in programs and new guidance documents it may feel like trying to hit a moving target. During online discussions, many device manufacturers indicated that their areas of biggest concern were inspections, followed by product recalls, warning letters, UDI implementation and CAPA. Clearly, no one is alone in their concerns.
Everyone knows that an organization has reporting requirements within their accounting departments, but an organization should think beyond financials and recognize that compliance is relevant to so much more.
When the FDA warns of further enforcement, it is not just an attempt to intimidate. There are teeth behind this procedure and companies need to stand up and take notice. Ignoring or excessively delaying a response will not make it go away, the ramifications will only increase.
Getting a new product into the customers hands as quickly as possible is critical to medical device manufacturers. Perhaps during the rush to hand off a product to the manufacturing floor, corners are cut. The end result can be manufacturing delays that prevent the product from going out the door – or even defective product reaching the customer.
Paying attention to the details up-front can save time in the long run. Resolving issues early in the process lends itself to a seamless transfer in house or to a contract manufacturer.