Many Life Science companies (Pharmaceuticals, Medical Devices, Biologics, and Diagnostics) use the SAP® platform as ERP (Enterprise Resource Planning) to manage their data and processes in an integrated way.
The implementation of an ERP is usually a highly complex project involving several professionals and areas, and its implementation is generally divided into a few phases.
In this article, we will address some solutions that SAP® provides to facilitate system implementation and discuss how the GO!FIVE® digital validation solution can complement this process, aiming to meet the specific regulatory requirements for this market segment.
Life Science companies operate in a highly regulated environment, i.e., FDA, EMA, and MDR (Medical Device Regulation), and need to prove and document that their products, systems, and manufacturing processes comply with regulatory requirements.
In this context, the objective of computer systems validation is to generate documentary evidence to prove that equipment, systems, spreadsheets, processes, and procedures are consistent with their intended use and conformance with regulatory requirements to protect patient or consumer, product quality, and data integrity.
ISPE® (International Society of Pharmaceutical Engineering) developed the GAMP Guide (Good Automated Manufacturing Practice) to guide the Life Sciences community in developing consistent validations.
Version 5 of the GAMP guide was released in 2008 and recently updated in 2022, bringing insights that can be very useful to a business.
There are several methodologies in the market related to project management, such as PMBOK and Scrum. However, for projects involving SAP®, the German company developed a specific process.
The first management methodology created by SAP® was ASAP® (Accelerate SAP) in 1990; that had five phases:
In 2015, with the arrival of the new version S/4 HANA®, there was the need to incorporate a new methodology, SAP Activate®. Among the most striking features is the adherence to the agile model.
Although the ASAP methodology is still in use, there is a tendency for the SAP Activate methodology to consolidate itself as the standard methodology for SAP projects.
ASAP and Activate are SAP® implementation methodologies.
Recently they updated and created SAP® Activate, which is very much in line with agile methodologies, which is the proposal of GO! FIVE®, cloud validation software, developed by FIVE Validation.
The methodology consists of guidelines on how to perform migrations or implementations. SAP® has roadmaps for various scenarios and suggests using tools in this process, for example, Solution Manager and ALM.
It is interesting to note that the implementation of SAP Solution Manager and SAP® ALM is a separate project that precedes the start of the ERP implementation project, requiring a lot of planning, anticipation, and budget for configuration efforts. Requiring configuration efforts to adapt the company's change management processes and GMP (Good Manufacturing Practices) rules adhering to the Life Science industries.
SAP Solution Manager is a management solution that can help you model projects within SAP, whether implementing Greenfield, Brownfield, or Bluefield. In addition, it has features that allow you to document and represent business processes in the scope of migration or improvements that will be implemented.
SAP ALM allows you to perform automated and manual testing within the SAP application. However, it does not contain solutions designed to manage the complete validation cycle and apply rigor to each validation step, requiring configuration/customization to comply with these regulatory requirements.
Below, some points are not native to Solution Manager/SAP ALM:
GO!FIVE® is a system specifically designed to manage the entire life cycle of validations and qualifications in compliance with regulatory requirements. It can generate dynamic reports (i.e., module, process, release) in the regulatory model accepted by bodies such as FDA and EMA.
GO!FIVE® is an off-the-shelf SaaS (Service as a Service) system that allows real-time remote management of all clients' validation/qualification projects. It is the only VLMS (Validation Lifecycle Management Software) platform on the market with content (requirements, risks, and tests) in the database.
Although SAP Solution Manager and ALM are useful, they have different functions/objectives than GO!FIVE®. Besides having pre-prepared validation templates, enabling 5x faster validations, the generated documents follow the regulatory model accepted by FDA and EMA and are also an excellent option to maintain the validated state after the go-live.
According to GAMP5, the overall extent of verification and level of documentation detail should be based on the risk to patient safety, product quality, and data integrity and focused on the intended use of the system. This approach is also similarly recommended by the CSA (Computer Software Assurance) guide issued by the FDA for quality assurance of software used throughout the manufacturing process and quality assurance of medical products.
The second edition of GAMP5 encourages testing to be more comprehensive than a detailed, prescriptive, step-by-step protocol. Therefore, it makes it more feasible to explain the testing strategy that the project team is applying. This approach can be justified in the Validation Plan or Test Protocol.
Tests foreseen by the project team can be addressed for lack of consistency in their evidence. However, the test script can be simple, especially tests related to transactions that are not critical and have low risk. However, it is still necessary to capture some data demonstrating that the test was/will be executed, how it was executed, who performed it, the date, problems faced in the test execution, and whether it passed or failed.
It is not a matter of accepting any lack of consistency in documentation by the project team, but with teamwork and documental best practices, they will be able to support the use of such tests.
Why not repeat or leave critical testing to the formal qualification phases of installation, operation, and performance so that quality is assured? In this case, using GO!FIVE® software, specifically designed to formalize approaches, strategies, and testing, adds expressive value.
Therefore, the level of test documentation required will vary depending on the risk associated with the feature/function. Traceability between test cases and requirements or specifications is essential to define the validation testing strategy.
For low risks of standard transactions, it is possible to decrease the documentation effort and use the SAP® solution for executing the tests. In this case, it is recommended that the document addresses the test executed within Solution Manager/SAP ALM to ensure traceability and the link to requirements and specifications.
Standard transactions with Good Practice impact (GxP relevant) with a low-risk result can have their tests performed in SAP SolMan and no longer need to be ignored for lack of consistency in their evidence. However, it is still necessary to capture some data demonstrating that the test was/will be executed, such as: who performed it, the date, problems faced when executing the test, and whether it passed or failed. However, the test script can be simple.
The following topics should have a more rigorous approach when conducting tests:
Remember that the validation study is not just about testing. A typical validation study for an ERP like SAP requires at least the following deliverables:
SAP SolMan or SAP ALM was not explicitly developed for validation studies in the Life Science industry. Both tools have to undergo a lot of customization and configuration to perform the functions of GO!FIVE® software, designed to accelerate the conduct of validation studies, is ready to use and cost-effective.
Another beneficial use is for applying regression tests to identify points of improvement and validate changes, and then move on to the next challenge (perhaps the most difficult one): maintaining the validated state of the SAP system after go-live.
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