COMPLIANCE SERVICES

​Once the ​software ​solution is chosen, implementation can begin. Implementation of new tools and software into an enterprise can be complex, depending on the size of the organization and your processes. We can help you have a smooth implementation based on our many years of expertise.

Modern QMS systems not only meet quality management needs, they also contribute to organizational objectives beyond Quality. Choosing the right one is critical to avoid complexity and high cost that may ultimately set your organization further back. As you research the many QMS software vendors, we can lead you in the direction that truly adds value to your organization.

Staying competitive in a volatile, complex and ambiguous business environment requires companies to continuously harmonize business process landscapes. We can help you achieve targeted business benefits  ensuring a harmonious acceptance of the new processes by various stakeholders

Process vs. Software​. Identify critical requirements that add value to your QMS implementation and eliminate nice-to-haves that can be costly, low-value distractions.

We specialize in ETQ software implementation, including configuration, validation and training services 

We provide comprehensive end to end software validation using a risk based approach following the latest regulations and standards.

Our Validation Services team can build the customer its own validation package that provides all the documentation needed to become validated, and even more important we can support in staying validated by providing Change Management services or Support subscriptions. We can offer a variety of validation services for customers.

We also offer services that look at validation by using the Computer Software Assurance (least burdensome) approach by focusing on 3 elements:

     ● Leveraging Vendor documentation  

     ● Defining  user needs / intended use 

     ● Risk approach on intended use   

The FDA acknowledges that existing approaches to computer system validation (CSV) are a significant barrier to improving digital capability. To mitigate this, the FDA recommends using  risk-based approach and customer to leverage of vendor documentation and methodologies to ensure that installations are tested with regard to critical risk in their intended use.  

The FDA is asking the industry to shift this paradigm back to a critical thinking approach, focusing on main patient risks with more concise testing and less documentation, in the past the industry gone about this in a “check-box” purely compliance-driven way.

Furthermore, ISPE GAMP formally endorsed this risk based validation approach in 2019. 

This new draft guidance to support risk-based computer software assurance is in the FDA list of  guidance documents that the Agency intends to publish during FY2020 (i.e. before September 30th, 2020). However, due to the ongoing international COVID crisis, this release may be delayed.   

Regardless, the FDA is encouraging the industry to NOT wait for its release, because it is going to be a non- binding “guidance” anyway – that is why many life sciences companies have already adopted this approach.  

We came up with great VALIDATION TEMPLATES to help customers streamline the validation journey and provide them a great starting point. These templates can be purchase and then updated:

• GxP and Requirements Risk assessment templates
• Validation Plan and Report templates
• Requirements, Test Script and Traceability templates

These can adapt based on your approach to Validation