Pharmaceuticals andFood, Chemical and Agro-Chemical Industries

IdeaGen software solutions are currently used in these high expectation environments where compliance is absolutely critical and key to the business. Compliance models from the FDA and 21 CFR Part 11 are achieved using our very configurable Workbench Professional suite as the framework.

Our customers include:

• Syngenta
• Avecia
• NPIL Pharma
• Kemfine
• IVAX Pharmaceuticals
• Newly Wed Foods
• Frank Wright
• Overseal Foods
• Aroma Fine Chemicals
• AstraZeneca
• Orchid Biosciences
  
  See our client list here
  

The Compliance Issue :

Can a vendor guarantee compliant software for Part 11?

"...It is not possible for any vendor to offer a turnkey 'Part 11 compliant system'. Any vendor who makes such a claim is incorrect. Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls that the vendor can offer. At best, the vendor can offer an application containing the required technical requirements of a compliant system..."

From Article: www.21cfrpart11.com

In 1990, pharmaceutical companies re-quested that the FDA look into accepting electronic signatures. In 1997, the FDA issued a regulation permitting the agency to accept electronic records, electronic signatures, and handwritten signatures. And last year, the FDA met with pharmaceutical companies and began to enforce the rule.

Rule 21 CFR Part 11 makes electronic records equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by the FDA that include good laboratory practice (GLP), good clinical practice (GCP), and current good manufacturing practice (cGMP).
The regulation establishes requirements to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent substitutes for paper records and traditional handwritten signatures. In addition to electronic records submitted to the FDA, the concept in-cludes output from instrumentation.

As defined by the FDA: “Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” An electronic signature, according to the FDA, is a “computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.”

"Certain signatures are required by predicate rules. If these signatures are executed
electronically, then Part 11 compliance is required. Part 11 also covers
non-required signatures if they are executed against required electronic records."
source


Workbench Professional provides the required technical requirements of a compliant system including complete and configurable access lists and not only forces a user to electronically sign at every stage, but also keeps a complete history of every significant action performed on your documents. It provides the administrative framework for your SOP's, processes, procedures and documents. Notifications are managed using the systems internal Task and Notification structure that can be linked to your internal email system to drive activity in your organisation.
Additional modules manage training and staff development as well as customer and client feedback and improvement. Auditing and Incident raising are managed and linked to the appropriate documents and staff to provide a cohesive approach.