In the pharmaceutical industry, the process is the product. Everything that happens at the beginning, middle, and end of the process is equally important for ensuring a safe and effective product. The problem most companies face is organization and aggregation of large quantities of data. The Cockpit Platform addresses this issue by functioning as a central repository to import and aggregate data into a single set that can be sent to manufacturing for final production.

How to Leverage Cockpit

Problems arise because organizations have a hard time managing the intersection of data, processes, and deliverables. All three areas of business must work together to produce a quality product; if one area fails, the whole system will fail. This intersection can be managed more easily with the Cockpit Platform.

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    Data

    All data used in the development process is collected from research and development, experiments, and lab data, otherwise known as batches. Cockpit’s REST API is designed to allow a user or team of users to select which data needs to be aggregated from those batches. Once all the work has been done, the output is an exportable document containing all the required information about the process and the drug being made.

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    Procedures

    Pharmaceutical and combination product developers and manufacturers live and breathe their Standard Operating Procedures (SOPs) and Work Instructions (WIs). These procedures and instructions drive the work of everyone in the organization. The Cockpit Platform’s unified model and centralized database make it perfect for housing these SOPs and WIs. Built-in workflow functions and other mechanisms allow for companies to insert their procedures and processes directly into the platform, making compliance with their processes easy. If SOPs change, the platform is ready to accept the changes to facilitate necessary modifications to procedures.

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    Deliverables

    Once all the work is complete, batches aggregated, reviews and sign-offs done, it is time to create deliverables. Cockpit’s capabilities allow you to export your electronic deliverables to PDF, Word, Excel, or XML. These exported files can then be moved to storage in your company’s system of record.


Pharma Features in Cockpit

ISA 88 defines the standard on batch processing for pharmaceutical companies, otherwise known as recipes. The Cockpit Platform provides a powerful mechanism for authoring recipes.
drugstability_report_incockpitDrug Stability is an important component of the pharmaceutical world. This process ensures your drug will maintain its effectiveness over a given period of time. It is also useful in setting expiration dates for drugs. While the active ingredients may still be present after n amount of time, the effectiveness of the dose is not. Drug stability is critical in ensuring a products safety and effectiveness over a length of time. The Cockpit Platform aids companies in complying with 21 CFR 211.166 Stability testing. Cockpit’s extensive testing capabilities allows for teams to create and follow through with a detailed testing plan as outlined in the regulation.
criticality_analysis_incockpitCriticality Analysis (CA) in the pharmaceutical industry is similar to preforming a pFMEA in the device side. The process of Criticality Analysis is in place to ensure the product that is being made is safe and effective for it’s users. Consider it similar to a combination of Design Inputs, Design Outputs, and Validation and Verification activities. Instead of being one piece of the pharma puzzle, CA is encompassed in all activities in Cockpit. Resulting in a safe product that will be produced as it was designed.
comparabilityreport_incockpitAccording to FDA a Comparability Protocol “is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product, as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” The Cockpit Platform allows companies to create comparability protocols that can then be submitted to FDA to ensure the modification still results in a safe and effective product.

Pharma Features in Cockpit

drugstability_report_incockpitDrug stability ensures your drug will maintain its effectiveness over a given period of time. It is also useful in setting expiration dates for drugs. While the active ingredients may still be present after an amount of time, the effectiveness of the dose may not be. Drug stability is critical in ensuring a product’s safety and effectiveness over a length of time. The Cockpit Platform aids companies in complying with 21 CFR 211.166 Stability testing. Cockpit’s extensive testing capabilities allow teams to create and follow through with a detailed testing plan as outlined in the regulation.
ANSI/ISA 88 and ANSI/ISA 95 define the standards for batch processing within pharmaceutical companies, otherwise known as recipes. The Cockpit Platform supports full recipe authoring and management. Using Cockpit’s reuse capabilities the platform can build libraries of processes, materials, and parameters. With little effort, organizations can easily create and maintain these libraries so everything is stored in one central location. Cockpit’s extensive workflow and review features allow teams to collaborate on both formal and informal reviews, as well as move recipes through the organization’s workflow. Easily import or export recipe structures using XML and visualize them using the platform’s powerful engine.
criticality_analysis_incockpitThe process of Criticality Analysis is in place to ensure the product is safe and effective for its users. Consider it as similar to a combination of Design Inputs, Design Outputs, and Validation and Verification activities. Instead of being one piece of the pharma puzzle, CA is part of all activities in Cockpit, resulting in a safe product that will be produced as it was designed.
comparabilityreport_incockpitAccording to FDA, a Comparability Protocol “is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC postapproval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product, as these factors may relate to the safety or effectiveness of the product (i.e., product quality).” The Cockpit Platform allows companies to create comparability protocols that can then be submitted to FDA to ensure the modification still results in a safe and effective product.

Risk Management

Manage all risk-related activities in Cockpit. Custom scoring and color settings are available.

Detailed Reporting

Cockpit’s built-in report and report creation abilities allow teams to gather information on anything.

Allocation Matrices

Easily allocate design inputs, users neets, etc. to sub-systems of the design.

Built-In Risk Analysis

Evaluate using FMEA, FTA, pFMEA, dFMEA, and more. All included with the Cockpit Platform.

Requirements Management

Manage all aspects of requirements and their connections within the platform.

Team Reviews

Hold informal and formal reviews of anything within your project. Everything is stored centrally.