Companies are constantly looking to improve their performance, agility, and efficiency of business processes, and they are driving the demand for their use of the Salesforce platform, which can deliver simpler, more intuitive, more agile, and more modest solutions.
We continue to notice an increase in the demand and use for Salesforce GxP validation and compliance as Life Science companies are increasing in the development and implementation of GxP solutions on the platform.
Solutions designed and built on the Salesforce platform may include functionalities and features for Life Sciences industries that help customers meet compliance requirements. For any IT system design, with the implementation of GxP best practices, Salesforce’s solution can be GxP compliant.
The compliance use of the Salesforce platform is dependent upon customers knowing and understanding their business processes to be implemented on the platform, proper solution deployment and configuration, management of the solution, and alignment with customers’ quality and IT policies.
Salesforce platform provides customers with a wide array of best-in-class security, data management, data reporting and audit trail capabilities which together enable compliance with requirements such as FDA 21 CFR Part 11 in customers regulated applications built with Salesforce.
In cases regulated customers may require certain specialized functionalities (such as electronic signatures or archiving), they can either be custom developed using the development tools or obtained from Salesforce partners on the business application store (AppExchange).
Any deployment of a regulated SFDC functionality should be executed in concern with the company’s quality and validation departments to ensure compliance with internal and regulatory compliance policies.
Life Sciences companies face the challenge of not only following exacting GxP regulations in their operations but to doing so with electronic systems conforming to regulatory requirements for electronic records and electronic signatures (FDA 21 CFR Part 11).
- GxP is a general term for “good practice” used to describe the quality guidelines and regulations applied in the life science industry that make food and medical products such as drugs, medical devices, and medical software applications.
GxP guidelines are regulated by the Food and Drug Administration (FDA) in the US and focus on traceability, accountability, and data integrity. Regulated companies follow them to make sure products are safe for customers, meet their intended use and adhere to quality processes during manufacturing, storage, and distribution.
- FDA 21 CFR Part 11 compliance enables regulated industries to use electronic signatures and other electronic records in record-keeping of their regulated information. It means these digital documents are just as official as paper records and handwritten signatures. By moving to a digital route, life sciences organizations can better track their compliance and ensure safe products for their consumers.
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Salesforce delivers a wide variety of functions, but not every single piece of the platform must be validated. It is important to clearly define the system’s intended use and focus on its validation.
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A good collection of requirements is a key point for efficient solution deployment and validation process. While defining your specifications keep in mind that good requirements should be Specific, Measurable, Achievable, Realistic, and Traceable.
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Do not forget that end-users and the IT team need to be trained on how to use and maintain the platform. Try to use SFDC documentation and materials as much as you can.
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Do not test everything at the same level. Adjust the depth of testing based on the risk of failure, the function of their importance and the likelihood or impact of failure. Configurable SFDC features may be tested only positively, whereas custom-built functionalities might need deeper verification.
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3 times a year Salesforce releases a new platform version with bug fixes and functional enhancements. Assess the impact on your platform and apply required actions: update of the documentation, verification/regression testing. The same approach is applicable for all internal changes, releases and upgrades.
- PRO-TIP 1: Avoid duplication of activities (e.g., by fully integrating engineering and computer system activities so that they are only performed once).
- PRO-TIP 2: Leverage supplier activities to the maximum possible extent, while still ensuring fitness for the intended use
- PRO-TIP 3: Apply critical thinking to requirements gathering and planning testing strategy over-focusing on your system documentation or regulatory compliance.
- PRO-TIP 4: Scale all life cycle activities and associated documentation according to risk, complexity, and novelty. Use of most appropriate methodologies e.g., Agile, and not just V-model.
When Life Sciences organizations use computerized systems to perform certain GxP activities, System Owners shall ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.
Here at Craftware, by working together with our customers we are available to assist in the assessment, design, implementation, validation and verification of the custom solutions you wish to deploy on the Salesforce platform to meet your business objectives and to ensure your compliance with internal quality system and external compliance requirements.
Validation Manager
acetera@craftware.biz
