Pharma and Biotech companies work on unplanned and planed deviations on daily basis. While dealing with regulatory bodies like US FDA and MHRA. They need to ensure that all the deviations must logged, circulated, studied and responded correctly to each associated process.
In a GMP (Good Manufacturing Practice) regulated environment where all activities and daily operations are governed by documented written procedures, there is always a possibility to deviate from these written procedures in a planned or unplanned manner. Reporting of these Pharmaceutical manufacturing process specific deviations forms critical in order to correct, investigate and prevent similar deviations with an effective CAPA. But the manual deviation system involves a lot of paper work and is often characterized by slow investigations, approval delays, lack of traceability, ineffective communications and ultimately repeated deviations. This scenario shows the need for an automated Deviation Management Software for all Life Sciences companies.
AmpleLogic Biochemical & Pharmaceutical Deviations Automation Software
AmpleLogic Deviation Management Software automates the manual process of handling planned and unplanned deviations from deviation reporting through investigation, CAPA implementation and closure. Quality metrics, drag & drop report generator gives study of all the deviations related to each process like human error, equipment etc.
Deviation (Planned or unplanned) handling plays a vital role in assuring quality of products with adherence to 21 CFR part 11 and EU annexure 11 which is an essential aspect of an automated Centralized Quality Management System.
This contributes to continuous improvement of Quality in Pharmaceutical Companies.
AmpleLogic Deviation Handling Software Features:
- Option to select deviation type and automatic display alteration of initiation information.
- Product or Batch impact mapping.
- Linking with repeated deviations based on company workflow.
- Assignment of CAPAs to individuals, department or groups CAPA, action plan, action items are automatically assigned from deviation application and option to attached additional action items if any.
- Easy to use deviation workflow automates review & approval process while E-mail notifications are automatically sent to responsible users for verification and escalation.
- End to end audit trail ensure to comply with part 11 requirements including E-signature, data integrity, record traceability and data security.
- Dynamic deviation reports to check the dependency and linking with other modules as per USFDA quality modules.
AmpleLogic Deviation software system Benefits:
- Enterprise wide 24 x 7 accessibility to Deviation Management System that allows access from any point within the organization at any time.
- Harmonizing the entire process of quality management by continuously integrating with other quality processes like CAPA, Change Control etc.
- Standardized Root Cause Analysis (RCA) and a distinct area to describe it with different methods of evaluation such as fishbone method, 5 why’s analysis etc., helps in maximum output.
- Impact to predefined Critical Quality Attributes (CQA) and Critical Process Parameters (CPPs) can be easily identified with AmpleLogic Deviation Management Software.
- Depending up on the priority of deviations (high, medium and low) actions can be taken.
- The information gathered over time through investigations contains a wealth of data that can be used for continuous improvement, increasing productivity, and reducing the reoccurrence of deviations.
- Data integrity, compliance with FDA norms, 21 CFR part 11 and EU annexure 11 is one of the biggest challenge for pharmaceutical manufacturing companies, relying on AmpleLogic Deviation Management system resolves all the challenges.
- Centralized access and integration with Document Management system allows to get supporting documents, SOP’s and pre-saved templates.
- Live tracking of deviations with automated alerts and notifications.
- Faster deviation reporting with simplified auto selections and reduced manual entry.
- Accelerated investigations with assignable investigation tasks and root cause analysis tool.
- Improved deviation closure timelines with best practiced workflows.
- Capabilities to integrate and establish closed-looping with another quality system.
- Customizable workflows, deviation reports according to the deviation templates of the company to suit your current process.
- Metrics reports or trends that are exclusively analytical and visually eye catching.