Official specifications, notification requirements, monitoring – regulated industries such as the pharmaceutical industry, medical technology or the food industry are constantly and intensively monitored.
The pharmaceutical industry is marked by high risks in product development. Development times of up to ten years are the norm and pressure from competition immense. In addition, production facilities are capital-intensive and it is therefore paramount to optimize the degree of utilization.
Meet requirements with IBS QMS solutions
Quality Management is Mandatory. The revision of ISO/IEC 17025:2005 demands more quality management in laboratories than ever before:
- The regulations concerning test reports have been tightened.
- New requirements regarding proof of qualification.
- Management processes are subject to increased requirements.
- Continuous and effective further development of the quality management system must be attested.
Requirements that can be met with the complete and reliable software solutions of IBS QMS.
Legal Validity of Electronic Data. The FDA regulation 21 CFR Part 11 relates to electronic records and electronic signatures. Specific procedures and verifications must be carried out with great precision when compiling, editing saving and transmitting electronic data. Software solutions used in FDA-regulated areas must be able to guarantee the authenticity and integrity of the electronic data. Electronic signatures only become valid once anti-imitation security requirements have been fulfilled and the signatures assume the same validity as those on paper.
Key Benefits of IBS QMS software solutions
Software that stands up to the most demanding tests. IBS QMS solutions are excellently suited to the regulated industries. The modules are qualified and then successfully validated on the customer’s premises.
A wealth of industry experience ensures quality. In addition to our highly functional LIMS/QPM system, we also offer CAQ systems for quality assurance and MES systems for production management. No other solution can currently match this range of functions.
Based on standard components. IBS QMS software provides a direct interface with SAP and supports all commercially available databases, such as Oracle or Microsoft SQL Server.
Reliability of all Processes
Regulated companies such as those in the pharmaceutical and food industries or manufacturers of medical technology use continuous and/or batch-oriented production processes. Compliance with quality guidelines in accordance with DIN/ISO, ASTM, GLP, GMP, or FDA is mandatory.
Specially-designed computer-aided quality and production management solutions – with validation in accordance with 21CFR Part 11 – are a real boon in the battle to reduce administrative efforts.
The reduction of testing, aftercare and rejects costs is an unspoken aim of practically every company in the process industry. A quick and efficient translation of research and development results is a vital factor in conferring new competitive advantages.
Users of IBS QMS solutions profit from our experience and competence. Our products fulfill official requirements, as well as company-specific standards. Further information can be found in our product brochures, which can be found in the downloads section.