We pick up in January 2022 by welcoming two new team members to assist us in accelerating the platform’s response times and streamlining document organisation. We completed Sharepoint Sync which enabled secure backups and meet our customer’s data storage compliance needs.
During this period, we conducted user research and interviews focused on batch comment management. These insights were instrumental in enhancing the platform’s features and shifting user perspectives toward embracing OneSC over the traditional spreadsheet approach. We embarked on the design of new features, including a permissions system and role-based access control, advanced sorting and filtering capabilities for platform and product information automation as well as implementing the comment management feature to foster improved collaboration on the platform. Our attention then shifted toward our next significant feature: archiving which aimed to reduce clutter on the platform by concealing released batches from view and also User Acceptance Testing for the next release, which included speed enhancements, archiving features and product automation.
We were actively interviewing candidates for the Junior UX role through the Kickstarter program, as we had received proposals from other businesses and engaged in discussions with potential new clients. In response to valuable feedback from our business partners, we made refinements to the system by incorporating built-in Vue tools, addressing identified platform weaknesses.
From May onwards, the focus shifted to the Operational Verification Test (OVT) of SharePoint sync. Furthermore, a significant effort was made in redesigning the platform’s front-end, resulting in improved speeds and a better user experience.
Things began to pick up as there were over 300 new documents added and our focus shifted to the next step of GAMP (Good Automated Manufacturing Practice) validation exercises. At the time, these exercises were carried out while adhering to the specified budget and constraints as this GAMP exercise was a mandatory requirement from our business partner’s quality assurance team.
Now, the emphasis remained on GAMP validation, with a particular focus on generating the necessary GAMP documents to ensure the validation process was comprehensive. This included creating documentation for the design qualification of OneSC. Risk assessment was also conducted, with a sign-off on identified risks and control measures. To further help with validation, Standard Operating Procedures and user guides were developed, enhancing the usability and understanding of the platform.
The team began developing a style guide for the structure of system feature components, ensuring consistency and efficiency in the development process. We also began enhancing Investor and Customer Product Decks for OneSC as this would be sent to potential investors and new customers, with a focus on evaluating the unique selling points offered by our platform.
We wanted to close out the year with a bang! Our team had used substantial amount of configuration and consumed significant resources to successfully deliver the Permission Model which allowed for a high level of customisation by creating various permissions and specific cases. OneSC’s data management capabilities were also enhanced as a new complex archiving epic was designed and implemented after many fixes. We had optimised code development and implemented critical features that were now beginning to add value for other businesses in the pharmaceutical space.
In January 2023, we proceeded to make significant progress in GAMP validation exercises. We dedicated substantial efforts to create and finalise GAMP validation documentation, particularly focusing on the Design Qualification.
We had begun conducting in-depth research to identify new features and unique selling points for our platform, aiming to enhance it’s competitiveness in the market. We commenced designs on KPI reporting, conducting interviews to gain insights into the key metrics tracked for batch processes which would enable OneSC to improve productivity.
The next crucial milestone was to advance the secondary packager flow by completing development and to address any existing gaps through rigorous internal testing to ensure the reliability and functionality of our platform. As we were going through more GAMP validation exercises, the final sign-off on a few critical documents such as the Validation Master Plan and Change Control Document was complete. However, we focused on documentation write-up and review relating to the areas of GAP assessment and Design Qualification which was pending for OneSC.
From here on we focused on building our brand and product into a marketable and validated SAAS platform. To know more about how we achieved this, stay tuned.