# Basic Pharma ## About Basic Pharma Basic Pharma is a Contract Development and Manufacturing Organization (CDMO) offering a wide range of pharmaceutical services. The company specializes in co-developing pharmaceutical formulations, manufacturing products for clinical trials, and providing quality control services. Basic Pharma focuses on the production of generic products for its customers, with expertise in nasal sprays, creams, ointments, and prefilled syringes. Basic Pharma experienced significant growth in recent years and now employs over 200 professionals across various departments. Basic Pharma has implemented SimplerQMS into its daily CDMO operations. Basic Pharma utilizes the electronic Quality Management System (eQMS) to help manage documents and improve transparency and control in different departments. Electronic QMS features such as electronic signatures and automated reminders and notifications help ensure tasks are done on time. The eQMS facilitated audit readiness and improved compliance efforts with Good Manufacturing Practices (GMP) requirements. ## Key Challenges Before SimplerQMS Before implementing SimplerQMS, Basic Pharma faced challenges associated with its paper-based Quality Management System (QMS). Basic Pharma operations produced a large volume of printed documents that needed to be manually handled, archived, and retrieved. The manual process took considerable time and presented risks related to document loss and inefficiencies in document control. The change control process presented another challenge due to its complexity. Change control processes require multiple people across various departments to create, review, and approve documents, as well as execute actions within predefined timelines. Using the paper-based system, the training management and onboarding of new employees required significant effort. Assigning and tracking training documents, ensuring timely completion of tasks, and maintaining records of who had been trained on which procedures were all prone to errors and lost documents. The implementation of SimplerQMS aimed to address these challenges by digitalizing and streamlining the quality management processes. ## Key Implementation Goals - Replace the traditional paper-based quality management system with a fully digital solution. - Improve compliance related to GMP requirements and demonstrate better control over quality management system processes. - Streamline the change control process to manage complex changes more effectively. - Improve the training management process and ensure all employees are adequately trained on the right procedures and work instructions. ## SimplerQMS Implementation The implementation of SimplerQMS at Basic Pharma was planned and executed through a structured five-phase process. Each phase contained the training and deployment of specific QMS modules. The implementation process was tailored to meet the specific needs of Basic Pharma. SimplerQMS follows a [streamlined implementation process](/content/implementation/index.html) completed within 5 – 6 weeks on average. A phased implementation approach ensures a smooth transition, with clearly defined milestones for each stage. The SimplerQMS system implementation phases for Basic Pharma were as follows: - **Phase 1:** The initial phase began with a kickoff meeting, followed by system configuration and training. During this phase, the [document management module](/content/modules/document-control/index.html) and [training management module](/content/modules/training-management/index.html) were implemented. - **Phase 2:** Phase 2 included training for the eQMS capabilities related to the [change control module](/content/modules/change-management/index.html), [supplier management module](/content/modules/supplier-management/index.html), [deviation management module](/content/modules/deviation-management/index.html), [CAPA management module](/content/modules/capa-management/index.html), and [complaint management module](/content/modules/complaint-management/index.html). Once training for these modules and their capabilities was completed, the go-live process for these components was initiated. - **Phase 3:** In phase 3, Basic Pharma successfully implemented the [product management module](/content/modules/product-management/index.html). - **Phase 4:** During this phase, the [equipment management module](/content/modules/equipment-management/index.html) was deployed, which improved the capability to track, maintain, and manage equipment and related software efficiently. - **Phase 5:** In this final phase, Basic Pharma deployed the [audit management module](/content/modules/audit-management/index.html). Throughout each phase, the SimplerQMS team worked with Basic Pharma to ensure the system was correctly configured for its intended use. Implementation included integrating various modules and optimizing the quality management process to meet the company’s specific needs. Some employees at Basic Pharma lacked experience with how to use a digital quality management system. However, Basic Pharma successfully implemented eQMS thanks to SimplerQMS’ unlimited training and support and a phased implementation process. ## The Benefits of the SimplerQMS Solution The SimplerQMS solution provided Basic Pharma with a set of comprehensive QMS modules specifically designed to address the quality management needs of the life science sector. Each module offered unique capabilities that streamlined daily operations and led to improvements across several areas. ### Improved Audit Readiness SimplerQMS provides an [audit management module](/content/modules/audit-management/index.html) that streamlines audit-related activities, reducing the time and effort needed during audits. The software allows for easy document retrieval and navigation through related documents. SimplerQMS provides time-stamped audit trails of all actions performed within the system. ### Control of Complex Processes and Tasks The [change control module](/content/modules/change-management/index.html) in SimplerQMS streamlines the change control process by managing the creation, review, and approval of changes. The eQMS ensures that everyone involved in the change process knows their specific roles and responsibilities, deadlines, and tasks, with all actions tracked and documented electronically. ### Predefined Workflows for Regulatory Compliance SimplerQMS offers comprehensive QMS process support, helping companies comply with life science requirements, including ISO 9001:2015, FDA 21 CFR Part 11 and 211, EU Annex 11, ICH Q7 and Q10, GMP, and others. ### Efficient and Accurate Document Management SimplerQMS [document management module](/content/modules/document-control/index.html) streamlines the entire document lifecycle, ensuring that all documents are tracked, version-controlled, and easily accessible. ### Ongoing Onboarding and Training of Employees SimplerQMS streamlines training management by simplifying the assignment of training tasks, tracking training progress, maintaining records for compliance purposes, and more. The QMS software helps ensure that all employees are trained on the required procedures and documentation. ### Streamlined Equipment Management SimplerQMS [equipment management module](/content/modules/equipment-management/index.html) provides a centralized digital system for managing equipment maintenance and calibration tasks. ### Robust Supplier Management SimplerQMS provides a [supplier management module](/content/modules/supplier-management/index.html) to manage supplier qualifications, approvals, performance evaluations, and related documentation.