Table of Content
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.
“One of the important things in managing a quality management system and being compliant with all regulatory [requirements] is having control [over processes]. And to know that tasks are done on time and that the system [SimplerQMS] guides you through [these 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 contains 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 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 and training management module were implemented.
- Phase 2: Phase 2 included training for the eQMS capabilities related to the change control module, supplier management module, deviation management module, CAPA management module, and complaint management module. 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.
- Phase 4: During this phase, the equipment management module 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.
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.
SimplerQMS supported Basic Pharma in drafting procedures by offering templates, providing hands-on assistance, and ensuring that every detail was aligned with the relevant requirements.
The implementation process provided Basic Pharma’s team with the tools and knowledge necessary for long-term success with the eQMS. SimplerQMS’s unlimited training, support, and implementation in phases made the learning process faster and helped employees start using the system more quickly.
“We implemented SimplerQMS step by step in different phases…so, step by step, we grew into it, and nowadays nobody knows how it was before anymore. So, that is a very good thing.”
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 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.
Basic Pharma streamlined the audit process, demonstrating transparency in processes and well-organized documents. With all documents stored in the eQMS, Basic Pharma no longer needed to print and manually compile documents for audits.
“We got compliments from auditors during audits and afterward. The way SimplerQMS works and the way we get all the relevant information [readily available] online in a few minutes [allow auditors] to witness the way SimplerQMS works and the advantages of it.”
Basic Pharma utilized SimplerQMS to display the quality management system on a screen in the meeting room, allowing auditors to navigate through processes and documents. The transparency impressed the auditors and demonstrated Basic Pharma’s control over its processes.
“All the documents are now digitally available. We don’t need to print out a lot of documents upfront. During the audit, we put the SimplerQMS on the big screen in the meeting room together with the auditors to be transparent, show them our QMS processes, and show that we are really in control of the different quality management processes.”
Control of Complex Processes and Tasks
The change control module 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.
SimplerQMS supports Basic Pharma in managing the change control process, making the entire process more transparent and controlled. The QMS software helped Basic Pharma manage change documents quickly by promoting collaboration among different departments. Employees have a clear to-do list visible on their dashboards, which ensures timely task completion.
“When I look at change control management, it is a really big advantage getting this complex process throughout a whole company with different departments in control. And to have different people all doing the things they need to do…in a timely manner.”
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.
SimplerQMS’s broad QMS process support and predefined workflows helped Basic Pharma ensure compliance with GMP requirements.
Basic Pharma knows exactly what stage a particular process is at, who is responsible for it, and who is accountable for each action. The eQMS helps ensure that tasks are completed on time and provides guidance throughout the entire workflow.
“The processes in our company related to GMP are improved by the use of SimplerQMS in a way that we have much more control over these processes. We know exactly the stage of a certain process and who is responsible for it, or who is responsible for which type of action.”
SimplerQMS offers predefined workflows that ensure employees follow the correct process steps, eliminating the need for personal interpretation of the GMP requirements. The eQMS tracks progress within the workflow and informs personnel of required actions.
The eQMS sends automatic reminders and notifications for actions, such as document reviews, approvals, equipment calibrations, process updates, and others. Daily use of SimplerQMS helps ensure that employees complete tasks on time and replaces the old reliance on Excel files for tracking actions.
Efficient and Accurate Document Management
SimplerQMS document management module streamlines the entire document lifecycle, ensuring that all documents are tracked, version-controlled, and easily accessible.
At Basic Pharma, the implementation of SimplerQMS improved document control, allowing for the digital creation, review, and approval of documents.
“One of the positive outcomes for our organization and operational efficiency is that the document control team works much more effectively since we have implemented SimplerQMS.”
SimplerQMS replaced the paper-based document control processes that required storing documents in cabinets. With an eQMS, printed documents no longer needed to be walked around the office for signatures, saving significant time and effort.
“With the digital way of working in SimplerQMS, we always have transparency about who is responsible for which actions. And when people leave, it is very easy to address those actions to other people.”
SimplerQMS helped Basic Pharma save time and ensure that no documents were misplaced or lost. The eQMS allowed for electronic signatures and document status checks, leading to a more organized and efficient workflow.
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.
Basic Pharma utilized the SimplerQMS training management module to streamline the onboarding process. Basic Pharma assigned learning materials and tracked new employees’ training completion. The eQMS offered a transparent and efficient training process to ensure that all personnel were able to perform their tasks.
“We have a lot of new people each month starting at our company, and through SimplerQMS, they know exactly which documents they need to be trained on.”
Training records were well-documented and easily retrievable, allowing compliance with training requirements to be demonstrated effortlessly during audits.
“We can very quickly see which person was trained for which document and for which process. In a bigger company, you cannot do that anymore using a paper-based [system]. It takes too much time, too much work, and will be very complex. SimplerQMS makes this very transparent.”
Streamlined Equipment Management
SimplerQMS equipment management module provides a centralized digital system for managing equipment maintenance and calibration tasks. The QMS software includes the capability to manage equipment documentation, set reminders for upcoming tasks, and record all equipment’s lifecycle.
Basic Pharma used the equipment management module in SimplerQMS to efficiently manage both equipment and related software within a single system.
Automated reminders ensured timely calibration and maintenance tasks, preventing equipment downtime and compliance issues. All documents related to equipment, including those for software used in manufacturing and quality control, are created, reviewed, approved, and archived within SimplerQMS.
Robust Supplier Management
SimplerQMS provides a supplier management module to manage supplier qualifications, approvals, performance evaluations, and related documentation. The QMS software helps ensure that all supplier information is recorded and readily accessible.
Using SimplerQMS allowed Basic Pharma to maintain an up-to-date Approved Supplier List (ASL) and easily access supplier-related documents. All critical supplier documents, including audit reports, questionnaires, and quality agreements, are stored within the system, allowing for easy document retrieval during audits and supplier reviews.
“We can show with the audit trail who approved the suppliers when they were approved, by whom they were approved, and also all the related documents.”
The eQMS enabled Basic Pharma to demonstrate during audits that each supplier was assessed and approved according to quality specifications. SimplerQMS facilitated supplier evaluations by enabling automated reminders for periodic reviews and re-evaluations.
The Ease of Interconnected Processes
SimplerQMS relates all QMS processes, such as document management, training management, change control, and audit management, among others. By providing a single system for these interconnected processes, the eQMS ensures that information is easily traceable.
At Basic Pharma, the related QMS processes enabled process transparency and control. Employees could easily navigate through different documents, products, equipment, processes, and more. The related processes reduced complexities in workflows and helped ensure that recorded issues were promptly identified, managed, and resolved.
“We can very easily relate the different processes and documents to each other, and then we can very easily navigate through the system.”
The related processes helped Basic Pharma ensure that no steps in the workflow were missed. For example, if a nonconformance report initiated a CAPA process, every action, from investigation to resolution, could be tracked and managed in the same system.
“We can easily go from one topic to another and show their relationships. Whereas in the past, it was just seeking in a big pile of documents that had no relations with each other.”
Faster Document Approval With Electronic Signatures
SimplerQMS improves document workflows by using electronic signatures, allowing companies to sign, approve, and track documents digitally.
Basic Pharma significantly reduced the time spent obtaining signatures, speeding up document workflows and approvals. The electronic signatures ensured that documents were authenticated, traceable, and signed in compliance with relevant requirements.
“Electronic signatures provide us with documents that can be signed in a digital way and don’t need to be transported throughout the whole company.”
Employees received automatic notifications when a document needed their attention, and they could sign electronically from any location and authorized device.
Notifications and Reminders for Timely Operations
SimplerQMS sends automated notifications and reminders for tasks and deadlines. The software helps ensure that all quality management activities remain on track and that nothing is missed.
For Basic Pharma, these automated notifications and reminders were helpful in maintaining compliance and operational effectiveness. Employees received timely alerts for document reviews, equipment calibration tasks, and training renewals, among others, ensuring that all tasks were completed in a timely manner.
“You get a pop-up when a document needs to be revised, and you get notifications when equipment needs to be calibrated on time. We don’t rely anymore on Excel files, for example, which only give you the information when you open the file. You get it in your mailbox now via SimplerQMS.”
Employees check SimplerQMS regularly, similar to how they check their email, ensuring they are always aware of their tasks. The “assigned” tab in SimplerQMS displays what needs to be done and when.
Improved Collaboration Between Departments
SimplerQMS facilitates collaboration between departments by offering a centralized system where all quality management activities and documents are accessible to authorized personnel.
Implementing SimplerQMS helped Basic Pharma improve collaboration between departments. Employees from different departments could easily access and contribute to documents without needing long in-person meetings or exchanging printed documents.
“A bigger project, like a change, can involve multiple people from multiple projects. But you know…who needs to do what and who is responsible for which action without having meetings where everybody should physically show up.”
Projects that require review and approval from multiple departments were managed more effectively. For example, a change control process involving R&D, quality control, and manufacturing could be clearly outlined in the system with designated responsibilities and deadlines for each department.
Reliable and Transparent Data Integrity
SimplerQMS ensures data integrity by providing a secure, traceable, and compliant eQMS system. System features, such as audit trails, version control, and electronic signatures, ensure that all data is authentic, complete, and tamper-proof.
SimplerQMS ensured data integrity for Basic Pharma by maintaining time-stamped audit trails for every action performed within the system. Each action performed within the system was approved and recorded with an electronic signature and timestamp, in compliance with FDA 21 CFR Part 11 and EU Annex 11 requirements.
“Everything is captured in the metadata, electronic signatures, and the available audit trail. You know exactly who is responsible and that they have to take ownership and responsibility for their actions.”
Data integrity was particularly beneficial during audits, as auditors could easily trace the entire lifecycle of documents and processes.
Improved Way of Working to Focus on Quality
The implementation of SimplerQMS changed the way of working at Basic Pharma and resulted in significant time savings across various processes and departments.
SimplerQMS eliminated the need for manual document handling and wet signatures by streamlining and automating quality management tasks. Employees can now focus more on quality processes instead of being overwhelmed by administrative tasks.
For example, electronic signatures automated the traditional routing of printed documents for signing, reducing the time for the approval process. Employees no longer had to spend time searching for documents in cabinets or walking through the corridors and putting documents on other people’s desks.
“In general, there is more time now for really working on quality and not on the administrative tasks from the quality management system because those are managed through SimplerQMS already for us.”