Remote validation in just one software - Systems - Software - Processes
Originally published on Industry 4.0 Blog by silvia_martins | February 04, 2021 07:19 PM
Generally, validation projects are conducted with templates created in Microsoft Word and printed on paper. However, with the increased amount of the information generated in the project, the process becomes bureaucratic and time-consuming. The spent time to record the evidence, preparation of the folders, printing documents and collecting signatures of analysts and stakeholders showed that it was necessary to update the whole process.
Physical documents are 'unique children'. There are no copies. In case of losses, it brings serious issues to the team who manages the validation. Since they are unique, the signature collection workflow depends solely and exclusively on the colleague signing so that the next can do so, a process that is time-consuming and requires the management of physical documents.
Keeping traceability manually on paper throughout the system lifecycle is a big challenge. When a change is made, it is an additional difficulty to track the impact of change on the validation deliverables. Does the difficulty increase when we respond to audit, how to manage roles changes, successfully and efficiently?
We estimate that paper-based validations and qualifications require human resources that spend almost half of their time on activities that have low added value and in case of mistakenly done, it may cause many issues that we have to deal with, such as:
Review and approval workflows, signature collection and management of dates;
Test evidence organization and collection maintaining integrity and consistency of dates. Tests correctly identified and correlated to the step in which the evidences belong to, attaching it to the correct test step, signing up and dating them;
Cancellation of unused fields, care in the traits and standards of each company, including signatures and dates;
Printing, scanning, and mounting folders;
Manage physical locations of folders and their conditions for auditing presentations
In addition to all these non-value-added activities, companies need to allocate safe physical spaces to store all these documents. In order to have a brief idea of the quantity of paper documents that are generated by a single system validation, we explain below:
CDS (Chromatography Data System) validation - chromatography equipment management software: on average, 320 pages of documents are generated without considering the evidences printed after the tests is done.
ERP validation: on average, 800 pages of documents are generated without considering the evidences printed after the execution of the tests.
In summary, the traditional paper-based validation format is expensive, retrograde, inefficient, and it limits business development. Day by day this model is becoming unsustainable bringing risks to compliance.compliance.
For the process to be paperless, it is not enough to use EDMS (Electronic Document Management System)
The EDMS software has become popular over the past decade. It is an interesting system, which should be used to manage GMP documents (Good Manufacturing Practices) such as SOP's (Standard Operating Procedures) and other quality system documents that have their life cycles controlled by this type of system, since its creation, review, approval, operation until its obsolescence. However, this type of platform was not built and designed to reduce the time involved in validation. What we want is to have a platform that automatically and electronically manages the validation lifecycle, which is not limited to preparing and approving documents. It is important to manage testing phases, its incidents, and reports.
Some disadvantages in using EDMS to manage validations:
Lack of mechanism for carrying out tests In general, companies end up having to print the approved protocols before being executed manually and digitalize them after execution (a lot of work!). Then, it needs to upload all the scanned files to EDMS. The chances of human error are enormous.
Insufficient information for validation management EDMS has appropriate information for quality documents control because they are platforms created for this purpose. On the other hand, there is a lack of needed information for decision making in order to manage validations and qualifications. As an example, it is not possible to know the number of tests performed, failures or incidences to be closed and to manage validation status.
Lack of accelerating library (pre ready validations as examples) EDMS does not have stored database information to contribute to the speed of the elaboration process of validation or qualification document content since it is not the objective of this type of system.
Absence of Automatic Traceability Matrix EDMS does not automatically generate any type of traceability matrix. This type of system was not designed to link requirements and/or risks to tests. The manual building of the matrix is possible, but extremely time-consuming (therefore expensive) and very subject to human errors.
GO!FIVE – Acceleration platform for remote validations
Taking into account the need to adapt validation processes to the advancement of technology in production systems, GO!FIVE appears. A cloud-based Paperless System Validation platform to be used on computers, notebooks and mobile devices such as tablets, adding mobility and agility to validation and qualification process.GO!FIVE is responsive, running on the most frequently used browsers such as Google Chrome, Internet Explorer and Firefox, in compliance with the requirements of FDA 21 CFR Part 11, GAMP5 and regulatory rules of FDA, while maintaining compliance.
Saving time and money in system validation and equipment/utility qualification The technological innovation behind the platform is capable of changing the way validation projects have been conducted so far. In addition to proposing and enabling zero paper usage, GO!FIVE has features that will reduce the project completion time by 65%, much more efficiently (find out how this is possible by reading this article to the end).
From preparing paper documents to online storage
All project documentation generated on GO!FIVE is stored online on a dedicated high-performance server, with international certifications and qualified infrastructure, which confirm the commitment to high levels of security, confidentiality and service availability.
The platform comes with standard models for each document deliverable according to GAMP and FDA guidelines. It is also possible to customize the template for the client's visual identity and use automatic content tags for GO!FIVE in order to insert the project information into the document. During the implementation, all possibilities of adhering to GO!FIVE databases the layout of the customer's default templates are studied.
The software has electronic signature and approval workflow that allows being configured to follow serial model (one approver at a time) or parallel (all reviewers and/or approvers work at the same time reducing the total workflow time). The design of this cloud system makes reviewing and approving documents remotely extremely flexible, which is a huge advantage when it comes to validation or qualification in companies with more than one site or working in a home office system.
The platform suggests risk scenarios and tests according to the system to be validated. Several libraries of systems typically used in the Life Sciences industries are now available.
Extensive technical knowledge Vs Knowledge Library
Systems Validation requires a multidisciplinary professional with extensive experience, understanding Validation Guides and the technology being validated in order to organize the information in a way that meets the expectations of the auditors.
This lack of expertise can hinder the process since the analyst is faced with systems that need to be validated but in different ways. As an example of diversity, we can mention validating SAP ERP (Enterprise Resource Planning) and a bottler - they are different contexts and control different processes, however, both are critical to the final product.
With GO!FIVE knowledge database (the library), the platform suggests risk scenarios and tests according to the system being validated. Several libraries of systems typically used in the Life Sciences industries are already available, however, over time, this knowledge database will grow according to available technologies. FIVE project consists of updating it throughout the software life cycle.
The existence of similar processes applied to different companies and a large number of system validation of the same type made FIVE's team have the idea of creating the library. These are processes that have already been carried out previously and are constantly being carried out. In these cases, the knowledge database is also efficient in suggesting actions, preparing the environment and discarding the need to start a validation project from scratch.
The library technical content is based on FIVE's experience counting on more than 500 validation projects. In case of the Analyst is faced with a system in which he has never validated, the library will suggest requirements, risks, tests and mitigating actions (in case of medium and/or high risks), since it already contains this intelligence in its database.
Systems Validation performed by items
In classical validation, the Analyst evaluates the entire system and generates at least one document for all requirements, another for all risks and other for the tests (divided into IQ Installation Qualification, OQ Operational Qualification and PQ Performance Qualification). In case of any changes in the system or in the project, it is necessary to register the change and control the version of all approved documents.
In GO! FIVE, you do not need to have all the system-wide risks and requirements approved before you start the tests. The platform treats these documents as items and allows their review and approval to be performed independently. There is also the possibility of one analyst create the requirements, while another one creates the tests, binds to this requirement and sends it for review and approval by a third party. Everything in real-time.
Another advantage is that in case of change, instead of generating a new version of the whole document, this versioning is done only in the item. The Analyst performs a search on the traceability matrix of the item in question, edits, updates the relevant item, and releases it for review and approval.
The Traceability Matrix is automatically generated by the system, which gathers the necessary information from the User Requirements, Risk Analysis and Testing to generate the document.
When handling deliverables by items, GO!FIVE speed up processes in maintaining the system's validated state. In classical validation, performed on paper, there is enormous difficulty in maintaining the paper reflecting reality in case of changes, because the process is time consuming and requires revision of most of the documents in the cycle. By allowing item validation, this update that could take days is accomplished within a few hours.
Each customer has a distinct tenant, so each customer has a different database section and it is not possible for a company access the data from another one.
The data entered into the system is customer responsibility. Clear safety policies make it clear that FIVE is not allowed (and should not) access customer validation data to generate the knowledge database unless our employees are involved on the projects.
The world is constantly changing
Currently, processes are evolving at an ever-increasing rate. Issues such as Industry 4.0, Internet of Things, autonomous vehicles, artificial intelligence, blockchain, data integrity, machine learning among several others that were unknown a few years ago are already, and increasingly, part of our daily lives.
GO!FIVE is a platform that has come to enable the industry to absorb new technologies, with better performance and compliance. If today, maintaining compliance has been a huge challenge, imagine how will it be to validate in the traditional paper mode and keep it constantly updated with all these technologies?
The platform has several other advantages over the classic concept of system validation and will contribute to reduce efforts, costs and time to validate a system while remaining in compliance.