Calibration management is very important part of any manufacturing facility. Especially Pharmaceuticals, FMCG, food & beverages are few of the industries which directly affect the life of billions of people that inhabit the Earth. So these industries are under the scanner of various quality and regulatory bodies, because a small mistake or failure could adversely affect the health of thousands of people.
That’s why these watching authorities has defined stringent guidelines and takes care that these industries are cautiously following these or to ensure the integrity of manufacturing process so the end user could get quality product.
GMP (good manufacturing practices) are the defined guide lines for Pharma industry for ensuring that products are consistently produced and controlled according to quality standards.
Effective calibration management is one of the component of GMP. Before discussing more lets understand what is calibration management?
Calibration management is the comparison of values gathered from an inspection or test of any instrument or machinery by instrument user, line supervisor, internal & external calibration team and instrument manufacture. Now the result should be documented properly for future reference when the next calibration inspection will be scheduled monthly, quarterly, biannually or after each batch.
In Pharma & FMCG industry production continues in batches so they need to calibrate their machinery or instruments at regular interval is very high. Each instrument should have a master history record, a unique identity, calibration period, and calibration error limits. Product, process and safety instruments require to be physically tagged and sometimes color-coded. Most of the companies are using Excel spreadsheets for managing that but not effective to answer the modern need like past trend analysis, alert for upcoming calibration, reports, factors behind the emerging need for calibration management software
QEdge provides you a centralized platform which streamline and automate your calibration management practices like managing master calibration data recording, history trend analysis, alerts and notification for next calibration, CAPA applied against deviation or error , eliminate the time need for documents preparation for compliance by engineers.
QEdge provides various crucial benefits like:
• Mobile paperless automated field calibration
• Fully automated workshop calibration
• Eliminate time/effort/cost
• Calibration never missed
• Be audit ready all the time
• Eliminate errors & repetitions
• Secure & transparent system
• Easy to store and archive documents
• Quick trend analysis and reports generation
• Allow engineers to utilize their time
• Comply with regulations FDA, ISO, GAMP, 21 CFR Part 11
• Trace calibrations, actions and resources
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