|
TAKE Solutions’ Life Sciences Division Announces Global Expansion of its Submissions Assurance™ Program (more)
TAKE Solutions’ Team Announces Conatus Pharmaceuticals the Winner in PharmaReady Best Case Study Contest (more)
New eCTD Submission Created Using PharmaReady 4.0 Passes FDA Validation (more)
Regulatory Compliance
In order to help you sell dependable, safe and effective products, the fully integrated PharmaReady Document & Submissions Solution Suite meets compliance with federal regulations and adheres to international quality standards. PharmaReady customers can rest assured they will achieve and maintain compliance with regulations and standards such as:
- 21 CFR Part 11 Cross-Reference: CFR Part 11 is defined as records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA Agency regulations. PharmaReady has all of the Technical Controls for 21 CFR Part 11 compliance, both procedural controls (notification, training, work flow procedures) and administrative controls (security, trustworthiness, and reliability of records).
- Current Good Manufacturing Practice (cGMP) Cross-Reference: Defined in 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, and Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals.
- International Quality Standards: PharmaReady understands and succeeds in meeting various International quality standards & regulations, exceeding the requirements of varying countries and regulatory agencies.
Related White Papers
White papers related to PharmaReady products provide practical information about using PharmaReady solutions in a regulated environment.
- Validated Document Management White Paper: Describes the general issues related to managing documents in validated business environments.
- Implementing a Regulatory-Compliant Document Management System – Easily: Practical Experience in the Implementation of PharmaReady™ Document Management System in a Validated Environment.