‘Digitization is transforming the DNA of industrial manufacturing’ said PwC in 2019. Today, almost every company has a strong digitalization program, accelerated by the Covid 19 pandemic. Speed and agility have become the underlying factors in determining a company’s resilience, which in turn determines their future success in an uncertain marketplace, driven by drastic changes in demand patterns, consumer sentiments and supply chain disruptions. Highly regulated industries like Medical Device manufacturing, have the dual challenge of speeding products from R&D to market, while also ensuring the requisite levels of process compliance and validation.

Regulatory agencies like the FDA (USA) and EMA (Europe) provide the guidelines and necessary oversight to ensure Medical Device manufacturers follow validation protocols for products and the underlying manufacturing systems, processes and documentation. Validation by its nature proves adherence to GMP (Good Manufacturing Practices). Process validation exists to confirm that a designed process will execute in a repeatable manner, to ensure the end product is of consistent quality and performance. For manufacturers, the benefits of validation include better repeatability, fewer mistakes, less rework and redesign, faster time to market, improved competitiveness, and lower production costs. However, the ultimate goal for validation is to ensure that each medical device is safe for patient use and will function correctly without error and potential to harm.

Validation for MES

In order to deal with the complex oversight placed by the regulatory agencies, most manufacturing companies turn to software applications like an MES to ensure adherence to validation norms and requirements.

An MES software-driven manufacturing process is subjected to two threads of regulatory oversight: one being CSV (Computer Systems Validation), which evolves into CSA (Computer Software Assurance), a more iterative and risk-based validation framework which is designed to help companies achieve CSV with less cost and effort. The other is covered by the FDA 21CFR regulations (21 CFR Part 820.70, Quality System Regulations) which are more holistic in nature.  

Part 820.70 sets out guidance for production and process controls, and specifies ‘each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.’ This is in line with the process validation guidelines — ensuring the end product consistently conforms to performance, material and quality specifications.

For an MES application implemented in a regulated industry like Medical Device manufacturing, it is mandatory to be compliant with both CSV/CSA and 21 CFR Part 11/820 requirements, as the former focuses on a risk-based validation approach and the latter is focused on ensuring that the whole system works in harmony, as a foundation for enforcing that established SOPs (Standard Operating Procedures) are controlled and can be validated through associated documentation, practices and procedures. 

While it is clear that validation is a mandatory requirement, the traditional approach to validation is a burden which deters companies from taking full advantage of their technology investments. It is estimated that validation, if performed using traditional methods, would take almost one third the time of an actual implementation of the MES.  

In terms of cost, the numbers associated with the traditional validation approach are significant: around $90 per hour and a total of 43 hours per test report when it comes to streamlined analytics reporting; 2000 hours of labor for risk-based Software Vendor Qualification; and an average 14 hours per script for Ad hoc/Agile testing. All of this time and money can be more effectively allocated: in R&D to make better products, and in manufacturing operations for improvements. This is where the Automated Validation approach is crucial in helping companies to reduce the time and cost of their validation efforts by at least 60-70%.

All about Automated Validation

So, what does Automated Validation entail? Are all MES vendors equipped with their own Automated Validation capabilities?

Automated Validation, as the name suggests, automates the activity of validation, which allows Medical Device and other regulated manufacturers to validate their process in parallel to their implementation efforts. This is a direct saving on validation time as opposed to validation performed post-implementation.

There are three levels of the Automated Validation offering:

  1. The first level is the foundational offering of Validation Templates. They adhere to the GAMP-5 Model, and include User Requirement Specifications, Functional and Design Specifications, all the way through the qualification documents. The templates include the surrounding traceability matrix, master plan and summary.
  2. The second level is the Automated Validation. Besides the templates, there is a set of validation scripts which are built and executed using a ‘Build’ and ‘Test’ Server and Test Runner to drastically reduce the validation effort.
  3. The third level is the Fully Integrated Automation Validation. An Azure DevOps environment is used, along with Modern Requirements and tools to facilitate teamwork and collaboration.

Automated Validation allows for complete traceability between the end user and customer requirements sets and has expanded features, out of the box, for product documentation, master validation templates, and version-related documentation.

The solution facilitates close cooperation and tight collaboration between the client’s implementation team and the vendor’s delivery team, allowing them to interact and assess progress on a common platform, which records and reports progress automatically. Additionally, it serves the purposes of both validation and training-related requirements.

Not all validation offerings are equal

Automated/Integrated Validation is a highly specialized offering. It was developed as a result of deep customer collaboration and years of expertise delivering complete solutions to regulated industry.

Companies with experience of the Automated Validation solution testify to its ability to reduce both the time and cost associated with traditional validation. For Medical Device manufacturers, subject to both stringent regulations and a fast-changing market, choosing an MES with automated validation is keying to add resilience to their manufacturing process.

To understand more about Automated Validation and how it helps meet both CSV/CSA and 21 CFR requirements, download and read our white paper: