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Pharma Features

Optimize Efficiency
And Total Compliance
For Effective Pharma Operations

Empowering pharmaceutical and life sciences companies with validated, configurable, and connected solutions

Trusted by a wide range of pharmaceutical and medical device manufacturers, Slingshot Software brings decades of expertise streamlining and optimizing quality and materials management processes. Our comprehensive solutions help companies achieve compliance with FDA requirements stemming from the Drug Supply Chain Security Act (DSCSA) and federal regulations imposed by 21 CFR Part 11.

Total compliance in an affordable, rigorously validated, and rapidly implemented solution.

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Challenges We Solve

Pharmaceutical and other Life Sciences companies are dynamic environments defined by innovation. Materials management and manufacturing processes evolve as science advances. Compliance with regulatory requirements requires detailed and documented operating procedures.  Controls and audit trails are paramount. Meeting these requirements with manual processes is expensive and prone to human error.  

Slingshot Software addresses these challenges “head-on” by providing validated software matching the exact functions and processes of each company. Controls are provided with checklists, user role restrictions, alert notifications, and electronic signatures.  Audit trails record the before and after value of every data element change, who changed it, when, and why.  In short, compliance is system enforced to ensure accuracy and reduce the need and cost of manually prepared documentation.

Our Capabilities

Built with the specific needs of the pharmaceutical and medical device manufacturers in mind, Slingshot Software offers a suite of capabilities tailored to meet the complex demands of these sectors. Our software excels in inventory control, lot genealogy, shelf-life tracking, electronic batch records, pedigree tracking, and more. With Slingshot, you can gain full visibility into your supply chain, maintain product quality, and ensure regulatory compliance.

Material Status Control
Track the status of material lots from Quarantined, Released, In-Process, Expired, or other user-defined statuses. Material availability to manufacturing or other processes is restricted by status. Status assignment can only be performed by users in a Quality role.
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Shelf Life Tracking
Effectively track and manage the shelf life of materials or products. Enable users to record and monitor expiration dates, retest dates, and other relevant information to ensure the timely use or disposition of materials based on their shelf life.
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Lot Genealogy
Reliably trace the lineage of materials or products throughout the manufacturing and supply chain processes to ensure quality control and regulatory compliance. Track of components used in the production of finished goods provides visibility into the relationship between the parent and child lots.
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Inbound Material Testing and Release
Enable organizations to define testing protocols, record test results, and facilitate the release or rejection of materials based on predefined criteria. It ensures that only qualified materials enter the supply chain, maintaining product quality and regulatory compliance.
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Stability Testing
Extend the life of valuable materials with a stability testing program. Set a test date for a lot prior to its expiration date. An alert informs quality personnel when the material is due for testing. Quality will organize the test, transfer the sample to the testing organization, review the test results, attach the results (C of A) to the lot, and extend the expiration date if indicated by the test results.
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Pedigree Tracking
This provides transparency, traceability, protection against counterfeit or adulterated products, and compliance with regulations such as the Drug Supply Chain Security Act (DSCSA). It records and tracks transaction history and ownership changes in the supply chain, with electronically signed Transaction Statements forwarded with the shipping documentation.
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Material Labeling
Enable organizations to generate and manage labels for materials or products. It includes tools for creating and printing labels with essential information such as lot numbers, expiration dates, and other required labeling elements. Material labeling ensures accurate identification, tracking, and compliance with regulatory labeling requirements.
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Sell Unit Serialization
Focuses on tracking and managing the unique serial numbers assigned to individual sellable units of drug materials. It enables organizations to record and maintain serial numbers for traceability purposes, comply with regulations, and facilitate product authentication, recall management, and supply chain visibility.
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Electronic Batch Records
These records document the materials, equipment, and personnel used to produce a manufactured batch. This avoids having to record this information manually.
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Detailed Audit Trail
Track and record all relevant activities and changes within the software system. It captures user actions, dates, time stamps, and reasons for changes, ensuring traceability, accountability, and compliance. Effectively provides organizations with an essential tool for investigations, regulatory audits, and maintaining data integrity.
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Certificate of Analysis (COA) Tracking
Allows you to attach COA documentation to a material lot. Test results can be stored as lot attributes for lot selection purposes.
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Checklists
Checklists allow you to document that certain steps in a process were completed. Checklist responses can be Yes, No, NA, Free form text or a valid table entry. Checklists can be required at shipping, receiving, batch creating or batch completion. Checklists require an Electronic Signature and can require confirmation by a second individual.
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Electronic Signature for Quantity and Status Changes
Electronic signatures (single or dual) are required for each process that changes the material status or quantity on hand. The user signing must be in a role authorized to approve the transaction.
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Challenges We Solve

We understand that every pharmaceutical organization operates according to its unique standard operating procedures (SOPs). That's why Slingshot Software provides unparalleled configurability through our robust toolset. Our solution allows you to align the system closely with your SOPs while adhering to Gamp5 - category 3 guidelines. With this level of flexibility, you can streamline your processes while maintaining compliance and control.

Validation Process

Streamline your validation process with Slingshot Software. With our well-thought-out validation process, you can achieve compliance efficiently and effectively. We offer one 180 OQ (Operational Qualification) script, reducing complexity and saving you valuable time and resources. Additionally, our Quality module ensures comprehensive validation while providing confidence in system integrity.

Connectivity

Seamless connectivity is crucial in today's interconnected world. Slingshot Software offers robust connectivity options through our comprehensive application suite, including ERP integration. You have the freedom to connect with your existing procurement and CRM applications or leverage our powerful built-in solutions. This flexibility allows for smooth data exchange, streamlining operations, and enhancing overall efficiency.

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