Biotechnology Regulatory Compliance Software
To allow biotechnology companies to demonstrate high levels of quality and compliance, organisations are legally required to comply with a number of international standards and regulations such as ISO, the FDA (including 21 CFR Part 11), US Environmental Protection Agency (EPA), US Department of Agriculture (USDA) and MHRA.
Achieving and maintaining compliance with these regulatory bodies is vitally important, and having a software system to effectively manage and maintain regulatory compliance, with an ability to adapt to a company's business processes, is crucial to the biotechnology industry.
Companies such as Alba Bioscience, Invitrogen and AbD Serotec, turn to Q-Pulse, a fully integrated regulatory compliance software solution developed by Ideagen, to help reduce the time, effort and cost spent managing their compliance activities. A central, electronic quality management system to streamline their compliance and quality processes, Q-Pulse enables biotechnology organisations to manage Document Control, Audits, Training and Staff Competency, Corrective/Preventive Actions (CAPA) or Deviation processes, more effectively.
Q-Pulse can help your company cost effectively achieve and maintain compliance to the latest biotechnology industry norms.
Feeling overwhelmed by your validation requirements? Ideagen and Q‑Pulse can help:
Ideagen offer our life science customers an end to end validation offering for Q-Pulse: Ideagen’s quality management software.
With our experience at delivering validation solutions to customers worldwide, we do all the hard work for you so you can;
- Align your validation plan to your configured Q-Pulse system
- Customise validation content into documents which suit your internal processes and requirements
- Make an informed decision on the level of validation testing your organisation needs to perform
- Significant reduction of the time, effort and cost of your validation activities
- Maintain your validation status against any future system changes
- Develop a validation plan specific to your organisation to achieve compliance with your key regulatory requirements, including the FDA 21 CFR Part 11 and Part 820; and EudraLex Volume 4, Annex 11.