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Why software validation is necessary to the pharmaceutical industry

Regulated pharma, healthcare, and biotech companies strive very hard to develop manufacturing capabilities cost efficiently and at a breakneck pace by safeguarding patient safety and product quality. It is more than 30 years that the industry is acquainted with validation that remains the backbone of the industries in ensuring regulatory compliance.  Although the process of validation has evolved with time and moved over from paper records to electronic documents and records, the approach to validation remains the same.    

Validation is a culture

Professionals in the pharmaceutical, healthcare and allied industries that operate under the watchful eyes of FDA are well conversant with the term validation.  Every process and system involved in the operations that lead to the delivery system related to the final product need validation for authenticity and integrity. All data generated from a validated system is considered authentic hence acceptable to FDA. All computer systems including software need proper validation by the guidelines set by the Food and Drugs Administration, which is the reason why Salesforce has created validation ready software. After you install the software, you can get the Salesforce health care validation done which is the process of ascertaining that the software meets the goals and requirements of FDA.   

Software validation is part of GMP

Current Good Manufacturing Practices or cGMP is the gold standard in manufacturing in the pharma, healthcare and life sciences industry. The FDA frames guidelines for achieving cGMP, the compliance of which means that the companies are capable of manufacturing best quality products by adhering to the best practices of the industry.  The stringent guidelines that form the core cGMP framework ensure that all companies adopting the practice follow the same standards in manufacturing without any deviation.  Software validation is a part of the validation process that applies to all processes related to manufacturing operations and is very much an essential component of cGMP.

Validation goals

Software validation in the pharmaceutical industry is part of the quality assurance process and is including in the testing phase. The need for validation in the pharmaceutical industry is more linked to ethical issues rather than being a technical necessity because the impact of the final products can have significant, far-reaching consequences. Validation ensures that the software is useful for the purpose for which it is meant and the software is compliant with the regulatory requirements as outlined in the FDA guidelines. Moreover, validated software is efficient and effective from a clinical standpoint. The validated software helps to check the functionality of codes besides ensuring that it is bug-free.

Substituting the paper based process

Use of electronic systems to generate and maintain documents became necessary to replace the less efficient paper based systems to enhance the efficiency of the manufacturing process.  Regulated companies use validated software as a primary resource to create compliance based efficient and certified systems that completely conform to the FDA rules and regulations related to electronic documents and electronic signatures.

Use of software streamlines the process and improves communication among stakeholders that helps to speed it up the processes and enhance efficiency.

Author Bio

Lucy Jones is an app developer who enjoys a professional relationship with Flosum.com. She is a specialist in the development of software for pharma and allied industries.  She is very fond of nature and often goes on jungle trips.

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