Pharma Focus

Pharma Focus – Pharmaceutical GMP Software

AmpleLogic specializes in developing end – to – end software solutions for the pharmaceutical, life sciences, healthcare, biotechnology, and other related verticals. Our product portfolio offers software solutions/products that are packaged to meet your business requirements – ensuring high quality, reliability, and performance. AmpleLogic Pharmaceutical GMP Software has been pre-configured to specifically address the requirements with the standards of FDA, 21 CFR part 11, EU Annex 11, MHRA and other regulatory bodies. 

Pharma Focus - QMS

QMS

Organizations that manufacture products within a GxP or Regulated environment are required to deliver quality consistently

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Pharma Focus - DMS

DMS

Challenges like lack of proper document escalation flow, improper document revision and getting document signatures made

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Pharma Focus - LMS

LMS

Learning Management Software (LMS) has been built to manage pharma-specific employee training and it’s life-cycle starting from induction till

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Pharma Focus - Quality Metrics

Quality Metrics

FDA Quality Metrics has widely used in the Pharmaceutical, Drug and also in biological companies need to monitor, evaluate their quality management systems

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Pharma Focus - APQR

APQR

Annual Product Review (APR) will be conducted for each commercial product manufactured in the Pharmaceutical, Biotech and Bio-similar Industry

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Pharma Focus - ebmr

eBMR

Electronic batch records systems will help the FDA Current Good Manufacturing Practice (CGMP) regulated companies to demonstrate the process

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Pharmaceutical GMP Software - Calibration

Calibration

Calibration management software directs calibration cycles and preventive maintenance schedules for all equipment’s

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Pharma QC Laboratory Automation - Quality Control

Electronic Log Book

AmpleLogic Electronic Log Book is a web-based application specifically deals with the requirements related to the Calibration, Equipment Usage, …

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Pharmaceutical GMP Software Quality Control

Quality Control

AmpleLogic is offering the Pharma QC Automation solution like Stability, HPLC Column

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Pharmaceutical GMP Software - RIMS

RIMS

Regulatory Information Management System is a web-based solution that helps life sciences companies to collaborate

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Pharmaceutical GMP Software - Incubation Management

Incubation Management

Incubation and Compliance Management is a web-based solution used to

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Pharma Focus - Compliance

Compliance Management

Incubation and Compliance Management is a web-based solution used to

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With a deep understanding of the pharmaceutical domain, accumulated over the course of years of research and interactions, we have built multiple ready-to-use modules to cater to the needs of QC, QA and production areas, which help in addressing the data integrity issues. Our quality driven products and solutions comply with industry standards like FDA (Food & Drug Administration), MHRA, EU Annex 11, 21 CFR Part 11 Compliant, ISO Standards, etc.

In the 10 years since we first started operations, we have had the opportunity and experience of working with some of the biggest names in the pharmaceutical, life science & healthcare sectors from both India and overseas, to support them in some of their complex and challenging initiatives while helping them derive good returns on their investments.

Our Pharmaceutical GMP Software solutions have been implemented at US FDA, MHRA and WHO approved manufacturers in the following segments

  • API (Active Pharmaceutical Ingredients) and formulations manufacturers.
  • Advance Intermediates and Fine Chemicals Manufacturers
  • Biotechnology and R&D
  • Biosimilar Manufacturers
  • CRAMS (Contract Research and Manufacturing Services) Companies
  • Small Volume Parenteral (SVPs)
  • Medical Device Manufacturers

AmpleLogic GMP software product specifically designed and developed for the pharmaceutical and Life sciences industries to manage day to day compliance requirements in Quality Control / Quality Assurance / Procurement / Stores / Production /Manufacturing and Engineering departments