Document Control Software: Q-Pulse for Life Sciences

Pharmaceutical and Biotechnology

As a Pharmaceutical or Biotechnology organization, you are mandated to comply with numerous regulations worldwide; whether the FDA’s cGMP or EU GMP guidelines from the EMEA, the design, development and manufacturing of pharmaceutical products in a robust quality-assured environment is an absolute prerequisite to gain regulatory approval to sell products to the Healthcare market.

In addition, with the advent of Quality Risk Management based on the ICH Q9 principles, the Pharmaceutical sector is now embracing a systematic risk-based approach to regulatory compliance, thereby increasing regulators’ confidence and addressing potential product risks.

With the penalties for failing to comply with laws and regulations also increasing, managing compliance with legal and regulatory requirements is increasingly important in reducing time and effort, reducing the duplication of effort and reducing resource expenditure.

Q-Pulse is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments including ISO 9001, GxP and ISO 13485.

Together with Q-Pulse's technical controls, our range of professional services, including supporting documentation and training, provide procedural controls that can help you to put the administrative controls in place for a complete 21 CFR Part 11 solution.