FDA Validation for BatchMaster ERP Software Request a Demo

FDA Validation Toolkit

FDA Validation Toolkit

Implementation Services

FDA Validation Toolkit Speeds The Process & Reduces Costs

GAMP 5 Guidelines describes in detail how cGMP requirements can be addressed by computerized systems and about the FDA validation strategy. As per GAMP 5, regulated companies have to document that GxP regulated systems (which keeps cGMP information) are compliant and fit well for the intended use. These guidelines define critical requirements expected of GxP computerized systems by building upon existing industry good practices in an efficient and effective manner.

FDA regulations say what a company should do, not how to do it. Without a set of templates to start with, many companies rely on their FDA validation service agency to write the necessary scripts, which adds time and cost to the validation process.

BatchMaster Software offers a set of validation templates in its FDA Validation Toolkit which satisfies FDA Guidance and ISPE GAMP® 5 best practices. These templates eliminate the need for the companies to write their own, thus accelerating the testing and validation processes, thus helping reduce validation services costs. The templates are kept in synch with FDA’s Validation best practices for documentation to reduce the risk of non conformance. For international businesses, the generated documentation is acceptable across multiple geographical boundaries, as they satisfy both FDA and ICH guidance’s (Q8, Q9 and Q10 ).

Follow the GAMP 5 Specification, Testing & Verification Process

Food Manufacturing ERP

Leverage the BatchMaster FDA Validation Toolkit

The BatchMaster FDA Validation Toolkit helps companies deliver consistent, repeatable documentation for auditor review for the initial and subsequent validations (due to system modifications). The Toolkit documentation includes:

  • Templates incl. Master Plan, Determination, Risk Assessment, Security, Trace Matrix, Migration Plan, Change Request, Recovery Plan, User Acceptance Test
  • Test Scripts incl. Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)

Leveraging the predefined test scripts, manufacturers can jumpstart their FDA Validation projects by personalizing these test scripts to meet their unique operations, which will then be tested and documented in accordance with the predefined templates. In summary, the toolkit documents are

  • Relevant – Required Documentation per Validation Step
  • Formatted – TOC of Objective, Sequence/Steps, Sign Offs
  • Operational Specific – Based upon Pharmaceutical operations
  • Software Specific – Identified BatchMaster ERP processes and transactions

Ongoing education and training

Education begins at our initial kick-off meeting with user training given during implementation go live, and then continues with BatchMaster University programs. Learn the tips and tricks for configuring your system, generating customized reports and getting the most out of your software by taking advantage of our available

  • Regularly scheduled live webinars
  • Online training and reference materials

Innovative Tools to Effectively Manage Your Growing Business

Google Type Search

Find related records rapidly

Relationship Mapping

View all record connections

Multilevel Workflows

Speed Management Approvals

Mobile App

Gain Visibility & Control. Anytime, Anywhere

Role Based Dashboards

Make more informed decisions, faster

Templates & Libraries

Employ preconfigured industry specific data

Growing Ecosystem

Add on SAP and 3rd party applications

Steps To Your Successful Remote Implementation

Learn how our project consultants and customers are working together, remotely, to successfully implement and be trained on our applications. Key objectives and virtual activities are presented for each phase of the implementation.

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Steps To Your Successful Remote Implementation
3 Keys to Ensure Your Successful Implementation

3 Keys to Ensure Your Successful Implementation

Whether you are implementing our manufacturing product suite or our end to end ERP solution, it’s a fact that the way your business operates will change. Our experienced consultants will help you prepare for the changes by providing you with a list of customer specific roles and activities that need to be performed during implementation. Let our user training programs convert your staff members into system advocates after they see the full potential of their new system and how it makes a positive impact on their daily jobs.

These common situations will impact your project implementation:

  • Users who really do not want to change the way things are currently done.
  • Customer project leaders who find it difficult to make important decisions or project tradeoffs.
  • Customer executives who are not deeply involved in the project anymore.

Recommendations to avoid these situations

Discuss ERP Needs with Experts

Contact US / Request a Demo

BatchMaster Software consulting team and toolkit can help prepare your team for your FDA Validation project. We can also recommend leading 3rd party FDA Validation agencies who can assist your team during the validation process.

Submit your Inquiry / Request

Upcoming Live Webinar

Discuss ERP Needs with Experts

Ensure Compliance and Traceability

Join us on our webinar as we demonstrate the following functions:

  • Manage Multiple Versions of Formula and Packaging Specifications
  • Generate Ingredient and other Product Labels
  • Maintain Electronic Batch Records
  • Perform Traceability Searches and Recalls

Wednesday, July 1
11 am PST / 2 pm EST

Documents

BatchMaster ERP Mobile

BatchMaster ERP Mobile

Read about the key manufacturing and warehousing tasks that can be performed using smart devices

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DS Compliance for CH chemicals

Chemical

This Chemical Compliance data sheet provides a summary of labeling, traceability and other compliance capabilities used by our chemical customers.

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Few key customer deliverables

Customer SOW

Customer SOW

Resource Schedule Budget vs Actual

Resource Schedule Budget vs Actual

System Personalization 3rd Party Integration

System Personalization 3rd Party Integration

Train the Trainer online & On-Site Programs

Train the Trainer online & On-Site Programs

Helping your staff manage change

Whether you are implementing our manufacturing product suite or our end to end ERP solution, it’s a fact that the way your business operates will change. Our experienced consultants will help you prepare for the changes by providing you with a list of customer specific roles and activities that need to be performed during implementation. Let our user training programs convert your staff members into system advocates after they see the full potential of their new system and how it makes a positive impact on their daily jobs.