Organizations dedicated to the life sciences have the conflicting needs of ever shorter development cycles, while maintaining strict compliance to US and International regulations. The need for speed and efficiency is driven by competitive market demands; the failure to meet compliance standards can result in costly delays.
In order to maintain compliance, organizations are put under intense pressure to process vast amounts of paper and electronic data. This information is related to each minute phase of the development, testing, quality and submission phases of product development, and extends fully to the end-of-life of the product.
In addition, if the flow of information is not efficient, the organization can be exposed to long delays and huge risks. These risks are often associated with a lack of proper management of the massive volumes of information from the initiation through reviewing, verification, recording, approving and completion phases.
To avoid or minimize these risks, life sciences organizations should adopt new information management strategies to improve product quality, efficacy and safety. The clear and proven path is the electronic record and document content management system that allows an organization to manage the following:
- SOPs (Standard Operating Procedures):
Describes the preparation, review, approval, authorization, issue, and control of Standard Operating Procedures in the R&D, Commercial, Marketing, Packaging, Advanced Labs, Manufacturing, Quality Control and Graphics Divisions.
- eCTD (Electronic Control Technical Documentation) submission for regulatory agencies:
An eCTD is primarily a specification for interface between the regulatory agency and the industry to enable the transfer of regulatory information while at the same time facilitating the initiation, creation, review, lifecycle management and archival of the electronic submission.
Change Control Process allow the organizations to enforce change control processes from initiation through review, verification, recording, approving and completion, thereby improving their product quality and safety.
- 21 CFR Part 11:
The 21 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. The technical and procedural controls for 21 CFR Part 11 compliance enforce controls on information access, change management, tracking, notification, training, work flow and administrative controls on authentication, authorization and integrity of records.
- 21CFR Part 211:
As per the CGMP (Current Good Manufacturing Practice) regulatory compliance stated in 21 CFR Parts 210-211, records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted for manufacturing process need to adhere to FDA Agency regulations. The technical and procedural controls for 21 CFR Part 210-211 compliance enforce controls on information access, change management, tracking, notification, training, work flow and administrative controls on authentication, authorization and integrity of records.
The Structured Product Labeling is a document markup standard approved by Health Level Seven (HL7) and adopted by US FDA as a mechanism for exchanging medication information.
- eCTD (Electronic Control Technical Documentation) Scanner:
i2Scan is complete enterprise scanning solution that allows a user to electronically capture paper documents, optionally extract metadata from configured zones using OCR, ICR, OMR or Barcode recognition and create Adobe Acrobat PDF documents in predefined eCTD folder structure.
- ED&CMS (Electronic Document and Content Management System):
Proactively manage enterprise content life cycle from inception, creation, review, process, transmission, storage, archiving, and dissemination of drug master files and dossiers.
Clinical Trial Management System manages planning, scheduling & tracking of clinical activities for phase I-IV trials; create, modify, maintain, archive, retrieve, or transmit clinical data intended for submission to the Food and Drug Administration (FDA). The data forms the basis for the Agency's decisions regarding the safety and efficacy of new human and animal drugs, biologics, medical devices, and certain food and color additives.
- Validation Services:
Computer Systems Qualification per 21 CFR Part 11, Design, development and execution of computer system validation including installation, operational and performance, generation of qualification and validation reports. audit and tracking management to provide stream line audit process.