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SAP Business ByDesign

Validation Services

The Benefits of an SAP Business ByDesign ERP Validation Process

FDA Compliance – Simplifying Your ERP Software Validation

FDA regulations say what a company should do, not how to do it. Without a set of templates to start with and expert guidance, many companies run into a stop and start learning cycle, which adds time and cost to the validation process.

With Navigator’s FDA Validation Service, your ERP system, and processes will be in compliance with federal guidelines and regulations.

Compliance with all applicable cGMP, FDA, and EU regulations as they pertain to validation (21 CFR 210 & 211; 21 CFR Part 11; EU GMPs; ICH Q7, Q8, Q9, Q10)

Simplifying Your ERP Software Validation

Cutting the Cost of FDA Validation

Life Science firms involved in pharmaceuticals, biotech and medical device manufacturing have the burden of being subject to the regulatory rigors of the FDA. To meet the demands of the regulations, their ERP platforms must comply with 21 CFR Part 11 as well as other parts of the regulation. This often requires engagement with qualified third-party auditors.

Navigator provides pre-packaged ERP solutions that can help streamline the validation exercise and related costs by implementing well-documented and tested best practices. This creates a validation-ready platform for the required process.

“We needed a GMP validated system to support regulated manufacturing and development processes. We also needed something that could fit our CDMO business and financial needs,” - Steve Gwynn, Director of Enterprise Systems at CBM Read on. . . 

 

FDA Compliance Validation

Busting the Myths of FDA Validation and Business Systems

Understanding the right process validation for Life Science manufacturers and distributors

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FDA Validation for SAP Business ByDesign

Provides documented evidence that your ERP solution is configured to meet your defined company processes and official regulatory standards. Validation is required for computer systems used to manage, control, and track the manufacturing and distribution of medical devices and pharmaceutical products.

Even though FDA Validation is required, ERP Validation can deliver big business benefits, including:

Ensuring High-Quality Standards Are Met Consistently
Accelerating the Production Chain
Safeguarding Materials Processing
Reducing Company Exposure and Risk

Resources

The Center for Breakthrough Medicines Implements GMP Validated System
What is GMP? Why is it important for Life Science firms?
Cut the Cost of FDA Validation with a Prepackaged ERP Solution

LIFE SCIENCE SUCCESS STORIES

“With a validated and scalable ERP system, the company is advancing its vision to build the world’s largest cell and gene therapy manufacturing and testing facility and enable the rapid development and delivery of groundbreaking treatments for patients,”
Peter Carbone
COO
Center for Breakthrough Medicines
CenterforBreakthroughMedicine-web-logo_dec2021

LIFE SCIENCE SUCCESS STORIES

"SAP Business ByDesign came up as the one solution that would handle everything we needed to handle"
Byron Dyke
CFO
BIODERM, INC.
BioDerm

LIFE SCIENCE SUCCESS STORIES

"We can run reports upside down, inside out, any way you want it, you can get a report to tell you what the numbers look like. We now have all the information in one system – from CRM to the end of finance, we have tracking on everything we need."
Leah Peene
BUSINESS ANALYST
CELONOVA BIOSCIENCES
CeloNova Logo

LIFE SCIENCE SUCCESS STORIES

“We told Navigator that we wanted their out-of-the-box, best practices for pharmaceutical companies"
Scott Harris
VP of TriRx
TriRx Pharmaceutical Services

Find Out How We’ve Helped Others Meet Their Goals

ERP Validation - A Better Way

Navigator's approach to validating and maintaining qualified technical system environments is specifically designed for life science organizations that manufacture and distribute medical devices and pharmaceutical products.

Our validation methodology starts by developing a Computer System Validation Plan (CSVP), tailored to your company’s implementation. Navigator’s FDA Validation Service your ERP system and processes will be in compliance with federal guidelines and regulations.

  •      Validation Toolkits
  •      Computer System Validation Plan
  •      Functional Requirement
  •      Operational/Performance Qualification
  •      Protocol/Test Scripts
  •      Distribution
  •      Master Files
  •      Manufacturing
  •      Risk Analysis
  •      Traceability Matrix
  •      Baseline Configuration
  •      Data Migration Protocol
  •      Systems Stress Test Protocol
  •      Final Validation Report

 

 

FDA Validation Systems and ERP

Write, coordinate, and execute validation protocols including IQ, OQ, and PQ for process and computer validation. Execute validation test functions in support of approved protocols. Review, summarize and present data in a summary report for management review and approval.

 

Security and Control

Security and control, which is essential to part 11. A documented user account policies is a big part of that. Minimum password requirements, password expirations, automated log-outs, discreet application authorization - all of those things that are known as good practice. Best practices today will help you pass the validation, for security and control.

Process Validation and Controls

Organizations need to have proper controls in place. In SAP Business ByDesign, you'll have a workflow that requires approvals to properly control access to information, approval of any documents which are going to be processed through the system transactions that are going to be processed through the system up to and including, having PINs, electronic PINs, to reinforce electronic signature. 

Vendors or suppliers can be approved and added to a vendor/supplier list, that may require an electronic signature in the form of a PIN, or electronic signatures in general.

Electronic Signatures

As people are logging onto the system and as you have proper access control through your password, user authorization, each of each document, each piece of master data needs to be user, date and timestamp. So as, as we're taking a look at this particular screen,

Whether bill of material or a purchase order, you'll have these types of controls in quality data that can be validated with proper electronic signatures. 

Good Manufacturing Practices (GMP)

Good Manufacturing Practices. A system for ensuring that products are consistently produced and controlled according to quality standards. Designed to minimize the risk, risk mitigation is involved in any production that cannot be eliminated through the testing of the final product.

So what does that mean? It means that you have a good manufacturing process in place.

You have good workflow requiring proper approvals with a trail of e-signature and a trail of traceability throughout that enforces good manufacturing practices and mitigates any risk associated with the production of that product.

Device History Records

Device History Records help ensure that everything that you define in that quality system is being done in this case, in the form of good engineering and change control management to support good manufacturing processes (gmp).

Track and Trace

We've all heard of track and trace. This is the ability to be able to know what went into a product, where that product has been delivered, where it sits in the warehouse, what transaction has been performed on it, who did it, what date, and what time.

Track and trace software should allow this data to be readily available. Having a system in place that supports that is key and essential to meeting the validation challenges.

Recall Management

Once taking the sales orders and manufacturing the product using GMP, you'd have kept track of where they've gone using track and trace, you'll have that ability to have CAPA cases and recall products by researching and identifying, and quarantining the product.

This is all key and essential to an overall system solution that's going to support your process validation with the FDA. 

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