Data Integrity is defined as, “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, and contemporaneously recorded, Original or a true copy, and Accurate.”
This is also known as the ALCOA principle guiding Data Integrity. The CCEA concept was added by European agencies.
1. Agaram Technologies
Established in 1998, Agaram Technologies (ISO 9001:2015 certified) is a leading provider of
enterprise-class Integrated Laboratory Informatics Software Solutions, Consulting Services,
and Product Support cum Training to laboratories in verticals like Pharmaceuticals, Life
Sciences, Biotechnology, Clinical Research, Contract Research Organizations, Advanced
physics, Chemistry, Nuclear research, material science, environmental, energy & geology
engineering.
Our products and solutions have helped our customers in QC and R&D laboratories meet
cGMP, data integrity, GxP, regulatory compliance such as 21 CFR Part 11, EudraLex annex 11,
ISO 17025 and other industry standards. We empower our customers to excelin their industry
via automation for the digital era.
Software for data integrity
Qualis DMS from Agaram tech is document management system software tailored to fulfill
data Integrity guidelines in lab and R&D related experiments as per FDA/MHRA standards.
Truly Qualis DMS tailors documents through category, collaboration, profiles, approval,
revision, automation, Issuance, merger and release adhering to 21CFRPART 11 Compliance
standards for GMP.
Alcoa data integrity
The ALCOA data integrity standards can be found in all Agaram tech data/system
management software’s. It is to maintain the completeness, consistency and accuracy of data
and those should be of Attributable, legible, contemporaneously recorder, true copy and
accurate as per established European CCEA standards.
2. 21 CFR Part 11 Compliance Management Software
Agaram tech’s Logilab 21 CFR part 11 compliance management software tailors uniformed
closed system capture of data, for all sorts of Instruments used in regulated laboratories. It’s
all in all control over data enhances one point sign report, data base connected to local PC
and storage of multiple instrumental solutions.
Features of ALOCA DATA INTEGRITY Software
- Attributable source of data with concerned person & process
- Legible storage of accurate data in Inventory
- Contemporaneous Data identified with date & time using GMP Standards
- Produce True copy with original data, time, date and person with electronically signed
records
- Data precision and mapping accuracy with optimised software for data integrity.
The ALOCA data integrity has a system architecture with Authentic, secured & protected
application data system with central data storage for retrieval of data.
QUALITY MANAGEMENT SYSTEMS & CERTIFICATIONS
At Agaram Technologies ISO 9001:2015 certified, quality is everyone’s responsibility. It is a
part of our DNA. We set the standards in laboratory informatics software products and
incessantly push ourselves so we provide our clients with the best value.
Our practice is to assist and support our clientele in meeting their goals. We ensure this
through conceptualizing, designing and delivering products that suit our end-users’ day-to-
day operational requirements to every last bit of detail.
With two decades of legacy in serving the crème de la crème, we have learnt the intricacies
of several industries. This has aided our process of innovation and pioneering throughout the
changing trends. Being agile, we could upgrade based on iterative customer feedback.