Exceptional Software Solutions for the Life Science Industry
No industry has more issues with quality and compliance than life science manufacturing. Whether the specific thrust is pharmaceuticals, biotech, medical devices, or food production, the requirements for testing, quality control and regulatory compliance are significant. Fortunately, SoftGroup has the life sciences software solutions to manage all data and reporting in virtually every area of need. We are a software solutions company that has an entire division of experts from the life science industry who have developed the most technologically advanced life science software to be found.
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- Huge Global Delivery Facility
- 24/7 Support
- Clients in the Biggest World Countries
- Quality Certification
- Variable Methodogies, surch as: RUP, Agile/XP and more
- Access to Highly Trained, Experienced Professionals
- Many Technology Skills Accessible in One Facility
- Excellent Protection for Intellectual Property
First and foremost, SoftGroup provides life science technology for the management and tracking of all data necessary for clinical trials, inspections and other regulatory agency requirements, history and calibration of devices, and, of course, health and safety. Accordingly, life sciences industry organizations of all sizes have come to depend upon SoftGroup for efficient and effective management, monitoring, and tracking of all areas of their business from inception of a product through trials, sales and distribution, compliance, CAPA, SOX, 21CFR, and more.
A reputation for quality of product(s) is the single most important factor in the life sciences industry. A company may need to track batch records, from initial production through distribution. Our software provides for complete batch history maintenance, as well as full security for access. Quality and compliance documents are developed for each client, dependent upon unique needs.
CAPA incidents must be fully tracked, and we design software for companies in all life science areas, to manage and monitor CAPA incidents through closure processes. Audits, complaints, and changes are all placed in related audit trails which are time stamped, thus providing accuracy and accountability.
Additional life science consulting services of SoftGroup relate to managing material controls, locations and distribution, the documentation and analysis of costs related to quality and compliance, and controls for testing and monitoring results, including statistical analysis of all testing. Company-specific forms and processes are designed for each client.
Compliance is an amazingly complex endeavor, and life sciences software must address these issues accurately and completely. First and foremost, any software company for this industry must provide for GMP principles and regulations. We have software to track compliance by specific principle and/or regulation for each product. Each FDA, SOX or CRR regulation that is industry-specific is included in SoftGroup’s life sciences software, in order to meet each client’s specific needs. For example, many specific industries must maintain complete adverse event reporting, including analysis, resultant tracking, full audit trails, and comprehensive reporting of all communication both within house, authorities and agencies. SoftGroup offers templates and documents for all of these needs, again, designed specifically for each industry’s requirements.
Many life sciences software companies do not include software development for the food industry. SoftGroup does! The same exceptional data, GMP, supply chain, tracking, inspection, audit trail, and data recording management software are designed for all food industry organizations. Food safety compliance and quality results in an industry’s reputation and consumer trust, and there should never be a decision to cut corners with software that does not provide comprehensive management, tracking and audits. The experts at SoftGroup do not cut corners and have the expertise to provide the perfect advice and solutions.
The life sciences industry is complex and continually facing new issues with quality and compliance. When SoftGroup is the software company of choice, the complexity and the new are handled with ease and grace.