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The pharmaceutical sector functions within a critical landscape where quality, safety, and regulatory adherence are essential. As international regulations become more stringent and the need for life-saving medications rises, pharmaceutical producers must implement advanced technologies to stay competitive. In this context, pharma software is instrumental in converting intricate production processes into efficient, compliant, and streamlined operations.
DoFort pharma ERP software enables manufacturers to manage comprehensive operations with precision, compliance, and efficiency guaranteeing product quality, patient safety, and business expansion.
Effective batch production is fundamental to the pharmaceutical manufacturing process. DoFort Pharma ERP software for the pharmaceutical industry enhances the efficiency of batch planning, monitoring, and record-keeping.
This extends beyond fundamental monitoring. The system implements detailed, real-time serialization of each ingredient and intermediate product during the entire manufacturing lifecycle, starting from the initial receipt of the API to the final packaging of the unit. This ensures complete transparency of product lineage (Lot/Batch Control). By recording every action and material movement in real time, the system provides prompt root-cause analysis, significantly reducing the scope and cost of potential product recalls to a precise level.
The software enforces and implements the Master Batch Record (MBR) in a digital format. It systematically collects and consolidates all operational data, sensor measurements, and electronic sign-offs from operators into a singular, unalterable, time-stamped electronic Batch Production Record (eBPR). This capability is essential for ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11 by eliminating manual transcription errors and maintaining data integrity (ALCOA+ principles) through a verifiable, tamper-resistant electronic record.
Product quality is maintained through the seamless integration at each Critical Control Point (CCP). The ERP interfaces directly with Laboratory Information Management Systems (LIMS) and external testing equipment. This guarantees that vital In-Process Control (IPC) and final quality test outcomes are automatically validated against established specifications and digitally sent back to the eBPR. No batch is allowed to advance to the subsequent stage or be released without instrument-verified, automated compliance verifications.
The system employs advanced Planning and Scheduling (APS) algorithms to dynamically model and enhance the production calendar. It intelligently considers all manufacturing constraints, such as the availability and expiration of raw materials, equipment calibration and cleaning cycles, as well as certified workforce capacity. This predictive optimization approach greatly reduces idle time and expensive changeovers, thereby maximizing overall Equipment Effectiveness (OEE).
The platform creates a unified source of truth—a centralized and secure digital repository for all GxP-critical documents, which encompasses finalized eBPRs, standard operating procedures (SOPs), validation protocols, and training records. This digital tool enables seamless audit trails and endorses a Review-by-Exception audit methodology, permitting inspectors to swiftly and effortlessly confirm compliance throughout the entire product history, significantly minimizing preparation time for regulatory inspections.
Regulatory agencies such as the FDA, EMA, and WHO require rigorous compliance with quality and documentation standards. DoFort pharma software assists companies in maintaining full compliance
The system functions as a Regulatory Publishing Engine, advancing beyond mere data capture to the automated assembly of intricate compliance dossiers. It produces version-controlled, audit-ready reports necessary for essential operations, such as the Certificate of Analysis (CoA) for batch release, Annual Product Review (APR) data, and organized documentation for NDA/ANDA regulatory submissions. This automation guarantees data uniformity across all report categories, significantly minimizing the time and potential for human error linked to manual reporting for regulatory audits (FDA, EMA, WHO).
This functionality facilitates the digital enforcement of Standard Operating Procedures (SOPs) and compliance verifications. Validation procedures (such as equipment calibration checks, material validation, and process parameter limits) are integrated directly into the operator's digital workflow. The system halts the progression of a task if any necessary validation protocol or compliance verification is overlooked, thereby guaranteeing that all production operations are carried out in strict accordance with the validated process. This streamlines Computer System Validation (CSV) and ensures ongoing adherence to Good Practice (GxP) standards.
The ERP system employs Role-Based Access Control (RBAC) to uphold the principle of least privilege, allowing users access solely to the data and functions essential for their specified job roles. This mechanism safeguards against unauthorized access or alteration of GxP-critical electronic records. In conjunction with secure electronic signatures and tamper-evident audit trails, this capability is fundamental for ensuring and sustaining compliance with 21 CFR Part 11 regarding data integrity, security, and traceability.
The system integrates IoT-sensor technology and monitoring algorithms to define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs). Any deviation from these established tolerances (for instance, a temperature fluctuation beyond the acceptable range or an erroneous material scan) immediately activates an alert. This swift notification enables the rapid initiation of Corrective and Preventive Action (CAPA), thereby averting minor deviations from jeopardizing an entire batch and transforming quality control from a reactive inspection approach to a proactive risk management strategy.
The Pharma ERP utilizes Barcode and QR Code scanning technology to create a definitive digital identity for each raw material, intermediate product, and finished goods unit. At each control point, the system requires operators to scan labels, promptly confirming the accurate material, batch, and quantity in comparison to the Master Batch Record (MBR). This automated verification process eliminates material mix-ups, guarantees the use of components that have not expired, and serves as a crucial element for serialization and comprehensive traceability.
This functionality automates and digitizes In-Process Quality Checks (IPQC). By connecting with shop floor sensors and instruments, the Pharma ERP system automatically gathers and verifies parameters (such as pH, temperature, and weight tolerance) against established Critical Quality Attributes (CQAs). Any immediate discrepancies activate a Real-Time Alert, enabling operators to stop the process and take action before a non-conforming batch is created, thereby greatly improving reliability and avoiding expensive scrap.
The Pharma ERP ensures procedural consistency by integrating Standard Operating Procedures (SOPs) directly into the logic of the production workflow. Each quality-critical task necessitates specific interactions with the system, including mandatory electronic sign-offs, photographic documentation, or verification of machine settings, prior to permitting the next step to advance. This methodology guarantees that quality protocols are adhered to uniformly across all production runs and locations, offering undeniable documentation for regulatory examination.
The system provides a thorough, closed-loop workflow for overseeing quality events. Upon detection of a deviation (whether via real-time alerts or manual entry), the Pharma ERP promptly initiates a formal investigation process. It supports the execution and monitoring of Corrective and Preventive Actions (CAPA), connecting the resolution to the initial batch record. This guarantees that root causes are tackled, recurring issues are avoided, and a comprehensive, auditable history of the quality event is preserved.
This functionality guarantees accurate and effective laboratory testing. The Pharma ERP creates distinct sample IDs associated with the production batch and seamlessly transmits the testing request along with specifications to the Laboratory Information Management System (LIMS). After the testing concludes, the certified results are automatically sent back to the ERP, which updates the Batch Production Record directly and aids in the final batch release decision, thereby removing the possibility of manual data transfer errors.
The Pharma ERP consistently compiles quality and production data to create dynamic Trend Charts and Predictive Dashboards. Through the analysis of both historical and real-time data, the system is capable of detecting minor variations in process parameters that could suggest an emerging quality concern (for instance, a gradual decline in machine tolerance).This functionality allows the quality team to implement proactive measures to prevent product defects and to manage equipment maintenance in a forward-thinking manner, transitioning from reactive fault detection to predictive quality intelligence.
Achieving optimal inventory levels while guaranteeing continuous production is a challenging equilibrium. DoFort pharma software streamlines the processes of material acquisition and inventory management.
Continuously oversee the stock levels of raw materials and finished products in various warehouses in real time to prevent shortages or excess inventory.
Initiate automated purchase requisitions according to established reorder thresholds or production projections.
Monitor the expiration dates and shelf life of materials to minimize waste and ensure adherence to first-expiry-first-out (FEFO) principles.
Synchronize procurement with production requirements to minimize holding expenses and prevent inventory obsolescence.
Evaluate suppliers according to their delivery efficiency, pricing structures, and product quality to ensure a dependable supply chain.
Traceability is essential for product recalls, ensuring patient safety, and adhering to regulatory standards. DoFort pharmaceutical software offers comprehensive visibility throughout the supply chain.
Allocate distinct serial numbers to products to ensure traceability at the unit level, adhering to DSCSA and various international regulations.
Monitor every ingredient and product from acquisition to final delivery to the end user, ensuring complete backward and forward traceability.
Keep detailed documentation of the manufacturing process for each product, encompassing raw materials, process parameters, and the personnel engaged.
Effortlessly exchange traceability information with external logistics partners to ensure complete visibility during transit.
Produce immediate reports during product recalls or inspections to facilitate prompt decision-making and reduce potential harm.
Precise formulations are essential for maintaining consistency and ensuring compliance. DoFort's pharmaceutical ERP software consolidates formula management to enhance control.
Oversee various iterations of a formula and guarantee that only authorized versions are utilized in production.
Determine the precise production cost by analysing the quantities and prices of ingredients to enhance budgeting accuracy.
Automatically modify ingredient ratios according to batch size to ensure the precision of the formula.
Restrict access to sensitive formulation data according to user roles to safeguard intellectual property.
Work in conjunction with research teams to facilitate a smooth transition from pilot-scale formulations to full-scale manufacturing.
DoFort pharma software stands out as a crucial solution for centralized documentation and reporting, which is essential for strict GMP compliance. By digitizing the entire lifecycle of controlled document management including creation, thorough review, efficient approval workflows, and strong version control DoFort guarantees operational transparency and data integrity. The system also enhances informed decision-making through automatically generated, real-time performance dashboards and detailed compliance reports, offering an immediate and precise overview of operational efficiency.
The secure archiving of master documents, complete with timestamped logs and undeniable digital signatures, ensures data preservation and facilitates smooth audits. Additionally, real-time updates and a comprehensive version history carefully monitor all changes, maintaining a flawless audit trail and consistent data integrity across all interconnected systems. Lastly, the integrated connectivity with regulatory portals such as the FDA and CDSCO simplifies the often intricate submission process, allowing for direct and effective communication with regulatory authorities.
DoFort's pharma ERP software enhances decision-making for pharmaceutical companies by utilizing data-driven insights through comprehensive analytics. The system carefully monitors essential production KPIs such as yield, downtime, and OEE, providing a detailed perspective on operational efficiency.
Harnessing AI and IoT technologies facilitates predictive maintenance, compares performance among teams, and highlights opportunities for minimizing waste and reducing costs. Tailored dashboards present role-specific information, allowing executives and managers to make prompt and well-informed strategic choices.
DoFort pharma software provides a scalable and adaptable architecture designed to accommodate the expansion of pharmaceutical companies. It supports operations across multiple locations and currencies, enabling global functionality. Its modular structure allows for customized implementation and straightforward scalability. With options for both cloud and on-premise deployment, it integrates effortlessly with LIMS, MES, and other essential systems. Workflows can be flexibly configured to align with specific operational requirements without the need for custom development.
The advancement of pharmaceutical manufacturing is rooted in digital transformation, with pharmaceutical software playing a pivotal role. DoFort pharma ERP software for the pharmaceutical sector enables companies to automate intricate processes, adhere to international regulations, minimize production errors, and improve decision-making. If you aim to enhance operational efficiency and maintain quality throughout your pharmaceutical manufacturing processes, DoFort Pharma software is the ideal solution. Contact our team today for a complimentary demonstration and explore how we can revolutionize your pharmaceutical operations.
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