Compliance in Informatics
SciCord Informatics Platform is designed for laboratory and manufacture compliance. Improve your compliance using validated formulas to eliminate calculation errors.
A Platform Built for Compliance
The SciCord Informatics Platform is purpose-built to establish a compliant laboratory environment, ensuring the generation of high-quality data.
The Challenges of Compliance in an Informatics System
[/card_face][card_back] Pharmaceutical laboratories that produce data and information for regulatory agencies face the challenging task of implementing systems and processes that comply with regulations. The effort required to establish and maintain compliance can negatively affect lab efficiency and incur additional costs.[/card_back] [/card] [card][style]min-height: 300px;[/style] [card_face]
The Impact of Poor Compliance
[/card_face][card_back] Without proper control and management, data can be improperly attributed, have insufficient auditing to prove it is correct, or be lost altogether. However, an overly restrictive electronic lab system can impede effective data visualization/analysis to achieve compliance.[/card_back] [/card] [card][style]min-height: 300px;[/style] [card_face]
The SciCord Solution
[/card_face][card_back] SciCord’s core is built from the ground up with compliance in mind – full audit trails, secure and automated attribution, CFR Part 11 compliant data storage, and validated calculations. On top of this core, a flexible no-code configuration system allows your processes to be fully captured. [/card_back][/card] [/card_row_flip][spacer]
Benefits:
- Data integrity measures for data entry, review, audit trails, data backup, data security, and electronic records management.
- Controlled document (notebook/experiment) lifecycles guarantee that laboratory records are authored, reviewed, and approved as required.
- Minimum 30% increase in reviewer efficiency results in timely document reviews.
- Process execution modules ensure strict adherence to step-by-step processes and comprehensive recording of all required information.
SciCord Informatics Platform is a critical ingredient in driving quality and compliance in your organization.
A Case Study in Regulatory Approval with SciCord
Aurobindo Utilizes the SciCord Platform for Successful Generic Filing
Using SciCord Informatics Platform, Aurobindo lab information was digitized to facilitate compliance:
- Instrument & equipment management
- Solution & Standard Prep
- Training (Curriculum and Records)
- Chemical Inventory
- HPLC Columns
- Analytical Execution Systems (DDU, NGI, Moisture, Leak Rate)
- Quality Documentation (Change Control, Test Methods, protocols, investigations, deviations)
- Validation Materials (Requirements, Risk Assessments, IQ, OQ, PQ, Validation Plans and Reports)
Situation
In 2016, Aurobindo established a new department dedicated to developing generic inhaled formulations. The competitive nature of the generic drug market necessitated speed and cost-effectiveness, putting pressure on the new development group to quickly deliver a product to market.
An expected Influx of new scientists into the group would necessitate extensive training and represented a potential source of error and non-compliance.
Quality data generated “right the first time” would be crucial for analyzing clinical material, ensuring stability, and supporting regulatory filings.
Impact:
The ability to develop and gain regulatory approval for an inhaled product would positively impact the company’s bottom line and would determine the future of the new development group.
Digitized data was easily identified and produced for audits.
Controlled review and approval of notebooks guaranteed adherence to defined process.
Implementation of lab execution processes ensured all required information was recorded and minimized the training required for new employees.
“We have been audited by FDA twice and they had no concerns about the system nor any findings.”
– Deb Carr, Director, IPD
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What Our Users Say
Don’t take our word for it. We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.
Contact Us
Reach out to Schedule a Meeting and get more information about how SciCord can fit into your lab
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