Laboratory Compliance

Laboratory Compliance in Informatics

SciCord Informatics Platform is designed for manufacture and laboratory compliance. Utilize an Informatics Platform that has built-in laboratory compliance structure for proper data attribution and data history to comply with regulatory agencies.

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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

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.

The Impact of Poor Compliance

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.

The SciCord Solution

SciCord’s core is built from the ground up with laboratory 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.

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 laboratory compliance and quality 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.

“

We have been audited by FDA twice and they had no concerns about the system nor any findings.

”

Deb Carr,
Director, IPD

“

This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

”

Josh Guyer,
Senior Pharmaceutical Scientist

“

In a head to head competition, SciCord was 3x more efficient at documenting a typical work process than [competition]. A complete ‘Assay’ work process required 60 minutes in [competition], while only 20 minutes in SciCord!

”

Indu Chowdhary,
PhD

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