Sage X3
Pharmaceutical software for mid-sized businesses
Business system coverage from concept to commercialisation for the pharmaceutical industry. Find the winning formula with enhanced ERP software applications. With Sage X3 your business can comply completely, guarantee consistency and manager your entire supply chain.
Sage X3 is a feature rich Web native ERP system that provides both established and growing mid-sized enterprises an affordable alternative ERP solution upon which to safely manufacture and distribute their pharmaceutical products.
Sage X3 helps enterprises address the key industry challenges of traceability, job costing, constantly evolving and changing regulations (System adaptability), data integrity and data visibility.
Sage X3 helps enterprises deal with industry FDA regulations which is key for international contract manufacturers supplying the USA. The system produces regulatory compliance reporting.
Sage X3 manages contract manufacturing arrangements & royalty calculations. Its manufacturing suite includes configurable quality control measures, electronic signatures, document management and new product innovation (NPI). Its projects and jobs functionality which includes NPI supports capture of regulatory steps & costs and pre-commercialization efforts (R&D).
Sage X3’s inventory management functionality supports lots, batches, forward and backward traceability, formulas, potency, and allergen tracking capabilities. It also manages shelf-life, cross contamination risks and hazardous material storage.
21 CFR Part 11 Compliance
Title 21, Part 11 of the U.S. Food and Drug Administration’s (FDA) Code of Federal Regulations requires drug makers, medical device manufacturers, biotech companies, biologics developers and other FDA-regulated industries (except food manufacturers) to implement controls – including audits, validation systems and documentation – for software and systems involved in processing many forms of data as part of business operations and product development.
The regulation was created to maintain the trustworthiness, reliability and integrity of electronic records and to ensure that the authenticity of electronic records would be equivalent to paper records when submitted. All companies and industries that submit or utilize electronic records and/or signatures regulated by the FDA must comply with this federal regulation.
But complying with the regulation proves to be a difficult task for most companies. Since Part 11 was introduced, manufacturers have endured much confusion as the regulation is open to a wide range of interpretations. Despite the confusion surrounding Part 11, one thing remains constant the FDA’s interpretation of the following requirements has not changed – controls for closed and open systems and electronic signatures.
With that in mind, compliance with regulatory requirements is a business-critical need that must be maintained, and the FDA recognizes that a technically advanced software solution can help companies manage compliance. Specifically, CFR 21 Part 11 states that enterprise resource planning (ERP) systems must provide:
- Extensive transaction audit functionality with field, user, time and date reference,
- Document signature printing association for technical or quality assurance generated reports,
- Digital signature to support field and/or screen level security authentication with change reason codes and access verification and historical user, time and date references.
Further requirements are associated with the concept of “validation” for both the manufacturer and the software developer. Guidelines require that the company’s needs and intended uses of its selected software system are established and that evidence that the computer system implements those needs correctly are traceable to the system design and specification.
To help companies adhere to 21 CFR Part 11, Sage X3 offers the following functionality:
Audit Trails: Associated with the creation, modification and deletion of electronic records, audit trails are now standard in Enterprise Management. The functionality records username, date, time, previous data, new data and the reason for the change.
Digital Electronic Signatures*: An electronic signature framework includes tables, programs, actions and objects to store, configure and collect unique e-signatures, which are permanently linked to the object and cannot be modified or copied.
Document Signatures: Documents requiring handwritten signatures, such as Certificates of Analysis or Technical Sheets, are generated with an image linked to the specific document. The image plate is controlled and linked to the user profile.
Validation Scripts: Documentation describing various process controls deployed by Sage is available. These scripts are flexible in design, associated with clearly identified and documented procedures. They are easily transferred or incorporated into custom validation and cGMP documents to support company initiatives.
Security Features: Several security standards safeguard against unauthorized use, including automatic logoff after a period of inactivity, auto logout after too many failed log-on attempts and logging of all user activity.
CAPA Management
Not all ERP systems manage Quality Control, corrective and preventive action (CAPA), & product non-conformance. They may provide lot, batch, or serial number tracking but rarely if ever do they support a products status of Q – quarantined, leaving companies open to the risk of using Q status stock for production work orders and shipping goods that are in a testing phase and which may not pass for sale. Suppliers of ERP software that isn’t designed for process manufacturers may propose creating a special quarantined stock location which only serves to add un-necessary business complexity that relies on manual interventions to maintain compliance.
CitySoft’s Sage X3 process manufacturing ERP system supports the application of corrective and preventative actions. Sage X3 will help identify the root cause of an issue, help create a new test plan and apply updated test results in the system.
A preventative action plan can be generated based on continuous improvement objectives including adjusting and improving QC tests on raw and finished goods to meet quality standards.
The system supports assignment of technical sheets to products as a part of a test plan.
Any changes to test plans, technical sheets, product ingredients or recipes are controlled through workflows and approval processes and limited to specific staff. A non-editable audit log is created.
Sage X3’s service request functions can be used to manage complaints regarding product defects.
With Sage X3 New Product Innovation (NPI), companies can now capture work effort, ideas, costs and much more in their Sage X3 system. Sage X3 NPI supports capture and testing of new SKU’s, formulas, and recipes during the design & evaluation phase of a products lifecycle.
The NPI functions sit inside the Sage X3 manufacturing suite utilizing the projects and jobs functionality to capture such things as labour by type, person, and cost, expended on a product and or project in the R&D stage. Since the NPI shares data from core Sage X3 costs, suppliers, materials, and other data can be used in the NPI processes and standard Sage X3 activities applied such as RFQ, alerts and workflows. With the first version of the Sage X3 supplier portal now released companies can anticipate closer ties and data exchanges relating to certifications, artwork and other matters that apply to the NPI phase.
Sage X3 NPI supports sales, marketing, procurement, and finance personnel sharing data with each other which helps get products to market faster and more successfully.
Key benefits for your business:
- Faster go to market for new products
- More secure and re-usable data than using Excel.
- Reduced risk of SKU non-compliance.
- Improved data accuracy
- Retention of re-useable data
- Reduced risk of disruption to the live business (Business as usual)
- Reduced costs of doing business
- Protection of business reputation
Integrate, Automate, and reduce the risk of errors.
Integrate Sage X3 for instance with weigh scales to automatically make stock updates and update work-in-process production management, in real time.
Weighing Scale Integrations
This Sage X3 capability is especially useful for life science companies such as manufacturers of pharmaceutical, nutraceutical and cosmetics.
Across Nutra, pharmaceutical and cosmetics industries, central weighing is a critical area in production units as all components must be carefully identified and weighed.
Weighing is an essential part of the production process and must be controlled and executed with both methodology and rigor to ensure that the products used are free from contamination and errors. The Sage X3 central weighing feature is used to define the weighing requirements of all products and raw materials.
With the ability to connect and interact with a scale device the Weighing Scale feature allows the automatic updating in Sage X3 of the weights on the scales, it updates stock and work-in-process production management, in real time.
Key benefits for your business:
- Secure weighing operations and component checks
- Visibility and assistance across the whole weighing chain
- Intuitive and controlled weighing: operators have a powerful system at their disposal which reduces the risk of errors caused by manual systems.
- Simplify processes with integration into the Sage X3 production management information system.
- Ensure compliance with standards (Pharmaceutical), full upstream and downstream traceability of materials.
Key Features
Drive the weighing through the weighing process by sending three different orders to the scale: Reset / Tare weight / Weighing.
Supports multiple weighing modes: Weighing by work order– Commonly used when components to be weighed are in the same process.
Weighing by product– commonly used for when a weighing campaign (grouping several work order and operation) is created to weigh the same component.
Weighing in manufacturing-when a direct use of the material in during the mixture operation.
The weighted quantity is recorded in real time to trigger Material tracking: normal action if the stock quantity is sufficient to issue the component stock.
Stock count movement: exceptional action if the weighing process highlights a stock variance.
To ensure traceability all data is captured including user, scale, quantity to weight, actual quantity weighed, tare weight.
Sage X3 Weighing station supports the following balance:
- METTLER Toledo
- Hub ID5
- Hub ID7
- Hub IND690
- Hub PM 3000
- SARTORIUS
- Hub ISI30
- COMBICS (CISL1 / CIS1 / CISL3 / CIS3 / CIXS3 ) (*)
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