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CIMINFO: Addressing Increased Attention of Data Integrity Compliance in Pharmaceutical Industry

Sanjay Agrawal,Founder & President

Sanjay Agrawal

Founder & President

At the fore front of the pharmaceutical industry, data integrity has become an area of great concern and focus. The A fact that compliance to data integrity is regarded as the next big call, is seen up setting the entire manually governed quality systems and regulation processes. Though the current digitization wave seems to digitize various sectors, the pharma sector seldom has the privilege of allowing any error while using data with electronic systems. This semi digitization approach needs a different over hauling approach with effective data integrity compliance. Aligning products and services with FDA regulations, USA head-quartered CIMINFO makes data integrity compliance quick, easy and seamless. The company with its Asia Pacific office based in Ahmedabad,India, has an extended client-base of over 500 spread across 30 countries globally. This leveraged client base of pharma and biotech sector receives productivity benefits when CIMINFO’s desktop tools transform client spreadsheets and Access databases into compliant data within few seconds.

The biggest issue today from a compliance stand point is data integrity. “The regulatory agencies and the pharmaceutical industry must have accurate and reliable data for safety and quality of products and services” states Sanjay Agrawal,President and CEO CIMINFO. This brings in special concern for the commonly used

spreadsheets and Access databases as these are available to every one and are commonly used for CGXP record keeping. These are often overlooked for compliances, there by exposing their firms to regulatory risks.

CIMINFO’s desktop tools transform client spreadsheets and Access databases into compliant data within few seconds

Achieving Data Integrity
with Proven Solutions From a quality standpoint, quality data becomes the basis for the companies’ branding between the industry, regulatory agencies and the end-users. The proven framework of CIMINFO’s solutions and services brings in complete, consistent and accurate data integration. The framework includes several modules one amongst which one is CIMINFO’s eInfotree Excel. This module brings existing Excel files into 21 CFR 11 compliance in a few seconds, thereby providing audit trails, security and electronic signatures. The ease of review and the ease of converting existing spreadsheets into compliant spreadsheets facilitate seamless audit trails. Spreadsheets used in a GCP, GLP or GMP process shows evidence of data integrity and 21 CFR Part 11 compliance for ease of review and approval. The spreadsheets are secure and only available to authorized users with the facility of e-signatures for firms that use them. A similar module is also available for Access databases.

The second module is XLVali that automatically creates protocols, spreadsheet specifications, and designs documents with only one input clients’ spreadsheet. It is also a design and development tool that instantly points out errors and potential issues in spreadsheets in a highly visual and

graphical way. It takes away all the manual and tedious work of creating validation documents and copying formulas from Excel into protocols.

The eInfotree Quality Management System manages all documents and data in a central repository with a single version of data while reducing review and approval delays. eCADInfo is designed for engineering data and drawing management. Mean while, CIMINFO’s e TraininfoTraining Management System allows users to self-train themselves on SOPs and other documents, give a test,and document their training record. This saves much of the instructors’ time as compared to a classroom style of training.

Presently, Data integrity compliance has several issues at stake. Any deviation from accuracy of data, audits and investigations are bound to take place with possibilities of tarnishing the brand names. The process of compliance entails the pharma sector to assure quality of products under several policies, protocols, reports and observations. CIMINFO products allow the pharma sector to meet all these requirements painlessly. CIMINFO’s inclusion in this list was based on the maturity and depth of its products, global client base, and completeness of offerings, product vision, and ISO-certified development processes.

Adapting Newer Compliances with Ease
While customers often buy a product for one location/site, often customers will expand their usage to other sites. CIMINFO’s largest implementation is 15 sites worldwide. Keeping multifaceted products and services at the helm, the company continues to invest heavily in innovation/R&D to maintain a stand in the market. CIMINFO ensures that their products provide a modern UI and performance to users, assuring compliance with latest FDA guidance. This also allows businesses to adapt to how end users are actually using the products making compliance a hassle free action.

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