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Software Validation & Infrastructure Qualification

“Computer system” is technically the hardware and software of a platform system.  Around that you need to add application software, ancillary equipment, people and procedures to form a “computerized system.” This computerized system then runs within a company’s operating infrastructure (or on in the cloud if run within a cloud-hosted service environment).Each of these elements within the computerized system need to be either validated or qualified.

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What is Software Validation?

Software validation is the process of establishing documented evidence that confirms a computer system has been installed correctly, will meet users’ needs and functions according to its intended use.

FDA software validation is when an FDA-regulated company demonstrates and documents that their software can accurately and consistently produce results that meet predetermined guidelines for compliance and quality management.

While the FDA offers recommendations, they don’t tell companies specifically how to validate their software, nor do they define what the results should look like. Instead, it’s up to each company to explain how they intend to validate their software, and to provide evidence for having done so in the way they intended.

Even though software is typically purchased from a third-party vendor, it’s the company, not the vendor, which is responsible for validation.

Need for Software validation

The tremendously vast & diverse pharmaceutical industry, under whose ambit fall drugs & vaccinations, pharmaceutical & medical devices, nutraceuticals, biotechnology, etc., is one of the world’s most highly regulated sectors with mandates impacting all the R&D, sample testing, clinical trials, product development, traceabilityquality management, and reporting related activities in this industry. The products in this industry are particularly scrutinized, because even the slightest of deviation in their quality can mean the difference between life & death, both literally and figuratively. No wonder the pharmaceutical manufacturers are compelled to indulge in continuous innovation and follow closely monitored processes to develop and manufacture effective and reliable products that meet the strictest quality standards.

In such scenario, the pharma manufacturers, who in the past deployed old-school methods such as spreadsheets, manual and paper-based processes, and siloed stand-alone solutions, etc. for maintaining the regulatory requirements, today seek assistance of tools that support innovation, producing cost-effective yet quality drugs, and help maintain quality/hygiene standards, patient safety, and meet regulatory requirements. With changing times and evolving needs, the regulatory requirements have only gotten more stringent. These requirements are subject to constant changes, and in no way can be tracked on paper or through manual processes anymore.

In modern times, enterprise resource planning (ERP) systems have emerged as that tool for pharma manufacturers. But to survive and prosper in such business environment, pharma manufacturers need to meticulously assess and comprehend the ERP systems that keep a close check on the manufacturing, procurement, documentation and traceability — while cost-effectively managing compliance requirements. In other words, the pharma manufacturers need to have pharma manufacturing software that should have got the testing and subsequent validation done; a software that is an integrated system which meets the business and regulatory needs by helping them get rid of the manual, error-prone methods, and meet all the local, regional, national, as well as international regulatory requirements, current Good Manufacturing Processes (cGMP) and Good Automated Manufacturing Practice (GAMP 5) norms, besides allowing them to record maintenance.

How to Validate Software

Validating software involves recording evidence that proves a software system meets the proper specifications and quality attributes; that it’s been installed correctly; and that it will fulfill its intended use.

During this process, you must validate the way you plan to use your software to produce regulated goods and/or perform related business processes. The goal is not only to prove the software will do what you want, but also to identify and mitigate problems that could negatively impact the production of regulated goods or their ingredients.

Most validation projects follow the same basic format, known as the “4Q Lifecycle Model.” It involves four stages of conducting tests and documenting the results:

So, how do you put these methods (4Q Lifecycle Model) into practice? Here are the common steps to software validation:

Step 1: Make a validation plan. Your validation plan is the “who,” “what” and “where” of your validation project. It documents and describes the software system; the environment it’s installed in; assumptions and limitations of the project; the testing and acceptance criteria you’ll use; the procedures you’ll follow; and who’s on the validation team and what their responsibilities are.

Step 2: Determine your system requirements (SRS). Outline the conditions that need to be in place for the software to perform the way you expect it to. These include infrastructure requirements — the necessary staff, facility and equipment — and functional requirements, including performance and security requirements, system and user interfaces and the operating environment. It may also include a risk analysis to identify any gaps in your functional requirements.

Step 3: Create a validation protocol and test specifications. Now you must outline what you expect the software to do and how you’re going to prove that it works. This involves creating a test plan and test cases. Your test plan documents why and how you’re going to test and verify the software. Your test cases will re-create common scenarios that prove the software can produce your regulated product or conduct a key business process. They are designed to uncover as many potential errors as possible and to demonstrate whether key features are performing properly.

Step 4: Conduct and document tests. Based on your test plan and test cases, this is where you actually conduct the tests and document the results, including successes, errors and failures.

Step 5: Establish procedures and write your final report. After you’ve completed testing, you must establish and revise procedures for using the software. Writing, reviewing and approving your final validation report is the last step before releasing the system for use within the company. This should also include information on support, training, security backup and recovery. 

What is Infrastructure Qualification?

IT infrastructure qualification is the process of demonstrating that IT components developed to be fit for their intended use can meet specified requirements and that the system’s fitness state is maintained throughout each point in the system’s life cycle.

In other words, it proves (with a high degree of certainty) that IT components, such as servers, clients, and peripherals, can meet the specified requirements for the various platforms, whether specific or generic in nature.

IT infrastructure qualification is a regulatory requirement according to regulations like 21 cfr. Part 11, Annex 11.

Infrastructure Qualification Plan

IT infrastructure qualification plan defines the framework to perform the initial exercise, and the ongoing work to ensure that the infrastructure remains in compliance.

IT infrastructure qualification plan includes: –

  • Background and history.
  • Roles and responsibilities.
  • System description.
  • Qualification approach – strategy to include:
  • Creating user requirements specifications.
  • Creating SOPs and policies.
  • Installation/operational qualifications.
  • Qualification summary reports

IT infrastructure qualification Tests: –

  • Training
  • Change control
  • Access security
  • Vendor support
  • Virus protection
  • Backup and restoration
  • PC maintenance
  • Periodic reviews
  • Deviations/incidents
  • Decommissioning network components
  • Contingency planning and disaster recovery

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