Spectrum Modules

Spectrum Quality Control Offerings

Quality Control (QC) is concerned with product sampling, specifications, and testing, and with the organization’s release procedures that ensure that the necessary tests are carried out and that the products are not released for use, sale or supply, until their quality has been judged satisfactory. Quality Control is the implementation of procedures, policies, and corrective actions necessary to ensure product quality. These activates also include daily calibrations, preventive maintenance and security checks as defined by internal processes and regulatory agencies.
Spectrum Quality Platform (QMS) is an integrated solution which includes inventory, media or Reagents/Media and stability management functionality, which seamlessly works with SpectrumLIMS and SpectrumMES.
Spectrum inventory management system monitors and tracks all laboratory items so that correct real time stock status is available at all times for better decision making. It organizes the items in various groupings and categories with an alerting system for tracking and reordering tasks.
Spectrum Media and Reagents/Media management maintains a complete list of purchased and prepared Reagents/Media and their costs, used in the laboratory. It also monitors the expiry dates of every reagent and forecasts the volume and type of Reagents/Media required based on testing plans.
Spectrum Stability module provides functions and features to control the complete life cycle study of a batch or sample in a simple and logical fashion. It provides product packaging, orientation, storage condition, testing schedule, degradation monitoring, comprehensive reporting and audit capabilities.
In conclusion, Spectrum QC is a comprehensive system which is fully compliant and seamlessly integrated with Spectrum products. It facilitates easy implementation of an organization’s quality control procedures, policies and activities with a customizable configuration, and user-friendly and intuitive approach. All Spectrum QC modules work in a seamlessly integrated manner providing data integrity, traceability, and security throughout the product life cycle.

Spectrum LIMS - Overview

Spectrum LIMS is an FDA 21 CFR Part 11 compliant software solution which supports a laboratory’s analytical and resource management needs, whilst monitoring compliance requirements. Spectrum LIMS is focused on optimizing laboratory performance and resource management. Optimization helps increase the laboratory’s throughput, saves cost, and enhances customer satisfaction.

Spectrum LIMS can easily process multiple types of samples, and can undertake various calculations or processes on each one. Sample testing can be grouped or performed individually as required. These groups can be by type of test (e.g. microbiological, toxic etc.) or by type of sample (e.g. raw material, finished good, water etc.). Spectrum LIMS also prompts for revalidation and repeat samples. The complete information of a sample is kept in Spectrum LIMS like sampling info, receipt info etc.

Simple and complex result calculating formulae can be defined into Spectrum LIMS, making it easy for the user to calculate final results from raw data. In addition to the final results, Spectrum LIMS maintains the original raw data to facilitate further analysis and decision making. Spectrum LIMS also manages repeat test results, providing a full history of tests and results on every sample.

The benefits of Spectrum LIMS include, but are not limited to, internal and external compliance, continuous improvement, resource optimization, cost efficiency, knowledge management, efficient time management, error minimization, and easy access to all quality–related information.

Spectrum Stability Management - Overview

Stability testing in the Pharmaceutical, Biotechnology, Food and Chemical industries entails product behavior monitoring during its complete life cycle spread over a period. The monitoring is performed across different months, storage conditions, packaging and orientations. Information and trends on the stability life cycle data are of immense importance for product evaluation and regulatory compliance.

Benefits: The benefits of Spectrum Stability include, but are not limited to, degradation monitoring, time saving and historical data maintenance, rework reduction, efficient time management and the comprehensive reporting of stability data.

Compliance: The system is designed to cater cGMP and ICH guidelines in every stage of stability studies.

Stability Management – Detailed Features:

Scheduling: Spectrum Stability handles stability studies of a sample on different packaging, conditions, orientations, and testing intervals. Spectrum Stability is capable of handling accelerated stability studies, in addition to routine studies.The schedule on which stability testing is performed varies with products and even with different batches within a product. The testing schedule of batches for which accelerated stability testing required is usually different from the normal schedule.

Worklist Assignment: With every scheduled testing of batch, the work list is assigned at test level to analyst(s) with date and time for the completion of test.

Testing Methodology: Any type of test like color, appearance having nonnumeric results to pH having numeric result to assay and dissolution having complex formula. Specifications / Limits for each test are maintained for all products. Reading groups can be created where there is a set of expected results. Different methods to perform a test can be defined into Spectrum. User can select the method using which user will perform a test on a particular sample.

User can define formula for result calculation according to their corporate procedural manual. These formulae can have test data (factors) with any number of readings and individual operations on these readings to obtain test data result that is to be put into the formula.

Testing Intervals: The testing interval can be defined on the basis of days, weeks, months, and years.

Storage Conditions: Stability testing is performed on various temperatures. Any number of storage conditions with temperature details can be defined into the system.

Shelf Life Calculation: Shelf life calculation for the batches in stability is a powerful feature in Spectrum Stability. The system has a comprehensive shelf life calculation mechanism as laid in Pharmacopeia guidelines.

The system performs shelf life calculation on test results for a batch up to the specified month with graphical presentation of shelf life with a detailed report of calculation.

Reports and Analytical Tools: Sophisticated analytical reports and dashboard capabilities are provided for trend analysis, statistical calculations, predictions and querying support.

Alerts and reminders keep informing the user about the important testing activities as per schedule and guidelines.

Spectrum Reagents / Media Management - Overview

Spectrum Reagents/Media Management maintains a complete list of purchased and prepared Reagents/Media used in the laboratory.

Details of the Reagents/Media Management and standards used in the testing of a sample are maintained within this module. Each testing method is associated with the Reagents/Media and the quantity required for that particular test/activity.

Spectrum Reagents/Media Management also provides the functionality to forecast the volume and type of Reagents/Media required based on testing/activity plans for different time periods.

Spectrum Reagents/Media Management monitors the expiry dates of every reagent/media, and then ensures that expired Reagents/Media are restricted from use for sample testing or solution preparation. The complete inventory of Reagents/Media is managed through Spectrum Reagents/Media, whether they are procured from external sources or are prepared internally. It also provides the complete location and inventory of different Reagents/Media, monitoring every individual lot.

Detailed records of in-house preparation and production are also maintained within the module. The system maintains real time inventory through monitoring receipts, consumption and adjustments, thus maintaining optimum levels of inventory to save significant costs associated with inventory holding.

Spectrum Reagents/Media Management also maintains complete record of receipts from suppliers to determine the supplier performance, and help with lot traceability.

Cost of Reagents/Media Management procured or produced is maintained which helps to determine Reagents/Media cost associated with each analysis. Furthermore while forecasting Reagents/Media requirements for a particular period – system also forecast the associated cost.

Spectrum Reagents/Media Management is an integrated part of Spectrum Quality Platform.

Spectrum Lab Inventory Management - Overview

SPECTRUM Inventory helps track and manage the inventory of all laboratory items, like glassware, chemicals etc. It makes the process of tracking and controlling all lab items fast and easy. The data for all items are updated in real-time so that you can have the correct, current stock position to help improve decision-making.

Spectrum Inventory provides real time inventory status with reorder point alerts to help maintain optimized inventory levels, reduce inventory costs, and monitor the performance of various suppliers. An unlimited number of inventory items can be maintained in Spectrum Inventory. All items are associated with their respective suppliers and manufacturers to identify the resources for any particular item.

Inventory management activities like receipt, issuance, stock transfer, adjustments, and other activities are kept in the system. Spectrum Inventory also provides the facility for returnable issuance of items, needed for those items that are temporarily issued and returned after some time. The system also provides prompts for the items due to be returned after specific periods.

Alerts and prompts based on the reorder point setting facility in Spectrum Inventory ensure that essential inventory items are never out of stock, thus ensuring the lab’s smooth operation.

Sample destroying procedure: Spectrum Inventory provides a wide range of output reports and inquiries that show the current inventory status, movement of a particular item, and item(s) that need reordering.

Spectrum Instrument Calibration - Overview

Spectrum Calibration helps track and manage the calibration and maintenance of instruments. It further facilitates in managing instrument’s inventory, scheduling, reports and certifications, and record management.

The data describing the actual status of a product is obtained from various lab instruments. Investment in the most accurate instruments yields the most reliable and valuable data about a product.

Calibration is to target quality and accurately control results in defined quality level with the minimal costs. In order to maintain the accuracy of the instruments, they need to be verified against reliable calibration procedures.

Spectrum Calibration can be set up to automatically calculate and update due dates. Users can find, sort, replace or filter records using simple commands. Drop-down menus minimize error entry and maximize consistency.

Spectrum Calibration is an integrated function of Spectrum Quality Platform.

Whenever an instrument is specified with a result– system checks whether the calibration status of corresponding instrument is up to date. If calibration is due on the instrument Spectrum does not accept the result.

Spectrum has the capability to acquire data directly from Lab instruments such as electronic balances, HPLCs, pH meters & etc. The data files generated from an instrument or loggers can be transferred using RS232 or TCP/IP connections. Data transfers or retransfers along with metadata are logged and tracked.
Using the interfacing capability of Spectrum, result or raw data can be transferred transparently to the system, reducing the chances of errors, and saving significant man hours.

System Interfacing – Overview

Spectrum has the capability to interface with all renowned ERP solutions.
Spectrum can support the import and export of master, sample, test and reporting data to and from ERP systems in a controlled process, ensuring data accuracy and integrity, reducing manual effort, and improving turnaround times for batch and lot dispositions.
Interfaces with ERP solutions can be easily configured or developed and maintained in Spectrum, supporting companies with their data management and interfacing strategy.

Spectrum users can be confident that data entry through instrument interface with the LIMS modules is fully secure, traceable, auditable, and accessible. Raw data files are saved and stored for any future need to run or rerun analytics using them.

Likewise, Spectrum ERP connectivity provides reliable connectivity to external ERP systems for SOP and other information retrieval.

Quality is never an accident it is always the result of higher intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives. William A Foster
Quality Assurance involves sum of all activities and responsibilities required to ensure that the product which reaches the customer is safe, effective, and acceptable to them. Quality assurance (QA) is a series of checks and internal audit performed to ensure the Quality Control procedures are functioning properly. In case there is any deviation or complain it makes sure that corrective and preventive action is taken to deal with any problem.
Spectrum Quality Platform (QMS) is an integrated solution to manage quality risk, out of specification, deviation, complaint, and corrective and preventive action (CAPA) workflows. The system also includes change control, internal audit, and supplier qualification functionality to make it a comprehensive quality assurance system.
Vendor qualification feature of Spectrum assures that suppliers with acceptable quality standards are selected. Raw materials received from suppliers are monitored to meet quality standards. Existing supplier performance history, new supplier qualification, evaluation and reevaluations are all tracked and can be reported.
Product quality issues and concerns are reported, investigated and any corrective action taken is monitored till completion through complaint, out of specification, deviation and CAPA modules.
Good Manufacturing Practices (cGMP) standards-based quality assurance activities are tracked so that products are consistently produced and controlled to quality standards appropriate to their intended use and required by the drug regulatory authorities.
Spectrum enables end to end visibility of any unpropitious or adverse events in detail and shows single pane of glass view of the processes across the organization.
Spectrum quality assurance system monitors process problems in near real time saving expensive deviations and recalls. Quality assurance procedures can be easily defined and monitored preventing any major slips in quality which may result in customer harm, loss of revenue and credibility.
Spectrum internal audit module facilitates audit planning, scheduling and initiation. Any audit findings can lead to investigation and CAPA invocation. Detail audit activities and outputs are tracked and reports can be generated on demand.
Spectrum provides electronic documentation facilities of eSignatures and eForms to accelerate formal and compliance related communication and approvals. eDocs eliminate the risk of lost, damaged or destroyed paperwork, increasing the quality, efficiency and traceability of the document workflow.
Spectrum QMS creates an interactive environment of quality assurance to achieve Good Manufacturing Process (cGMP) implementation for all the organization processes. Workflows are managed intelligently throughout Spectrum for internal and regulatory compliance. All Spectrum quality assurance modules work in a seamlessly integrated manner providing data integrity, traceability and security throughout the product life cycle. Spectrum has customizable configuration system which maps well to setup and operation of SOPs and compliance checks of any organization intelligently, saving time accelerating time to market.
Spectrum Quality Platform’s user-friendly approach, intuitive user interface and workflows captures user interest and makes the system usage an enjoyable experience.

Spectrum Vendor Management/Supplier Management - Overview

Supplier or vendor management is very important for a manufacturer to receive consistent quality, supply and lower cost of raw material in a cost-efficient engagement process with the supplier. This involves monitoring, developing and motivating suppliers for timely, high quality and cost-effective deliveries. The goal of vendor management is to ensure that a manufacturer is obtaining the best value from external products and services providers while controlling exposure to vendor related risk.

Spectrum Quality Platform has an integrated supplier management system for vendor governance to manage the entire vendor management lifecycle. The system has complete traceability of qualification process from its inception, progress, and completion. It proactively highlights any problems automatically and maintains record of all suppliers. The supplier data and supporting documents are all kept in a single database for data integrity, transparency, and easy access. The supplier management workflows and notifications are also integrated with investigations and CAPA modules for communication and transparency in case of any issues and rapid investigations.

Spectrum Supplier Qualification system uses supplier information to rank vendors based on their performance. The supplier performance is tracked according to the specification set by the purchaser. Specification ranges can be set for vendors to measure the raw materials and payments can be set according to those ranges.

The system workflows make it easy to audit new suppliers and track the approved ones to avoid supply chain risks and disruptions.

New media and reagents can be tracked and documented by the system for compliance reporting till they are reviewed and approved by the compliance agencies.

An integrated supplier management system improves transparency of vendor evaluation and selection along with performance management, helping solve issues rapidly and making sure that your supplier is contributing to your value chain as per changing business demands. Spectrum Quality Platform supplier management system improves the internal processes of evaluating, tracking, monitoring and ranking suppliers, thereby protecting and improving your product quality and brand reputation.

Spectrum Complaint Management - Overview

Since we do not live in an ideal world, there are product failures and defects reported by internal or external customers. Even though every product goes through a rigorous manufacturing quality management system, inevitably some defects are not identified by the QA/QC system resulting in customer complaints that may result in a product recall.

An effective complaint handling system is a corner stone of a quality management system for highly regulated industries. A company’s brand reputation depends on customer reviews, and how rapidly it responds and resolves any complains and issues.

Spectrum has an integrated end to end complaint tracking system built into the Spectrum software, to record, track, investigate and analyze complaints from internal or external customers, manufacturing or other sources. The system registers each complain responding to the complainant and pro-actively notifying the relevant personnel who are involved in the process to take actions and starts the process of initial findings. Once initial findings are completed a formal investigation process is invoked and CAPA initiated if required, else relevant actions are taken to close the incident.

An effective Complaint management system and trend analysis is crucial for gaining external customer confidence, improving internal issues and unmasking hidden reasons for defect escapes and in the end company reputation. It is crucial how a company uses and deals with customer feedback to improve its products, fix problems and conduct its communications.

Spectrum Complaint management is a fully compliant system which meets all regulatory requirements of recording, responding and tracking all complains end to end.

The Complaint system being an integrated part of Spectrum, has access to all the information about the potentially defective product or process. Spectrum Complaint enables companies to implement a comprehensive paper-less mechanism to manage the workflow of customer complaints. It keeps an end-to-end track of all complaints and pro-actively prompts the relevant staff members who are involved in the process to take actions on each complaint. It also ensures compliance of the defined SOPs while keeping complete record of all investigations and corrective actions (CAPA) taken on that complaint.

As soon as the complaint is registered Spectrum automatically routes it based on manufacturing location and product and complaint type. The system immediately informs all the relevant people involved without any delays to investigate and stop any ongoing defective process or products being shipped from the factory. Depending on the investigation results the system, if required, invokes CAPA based on defect classification and risk based assessment.

Spectrum complaint system ensures compliance of the defined SOPs while keeping complete record of all investigations and actions in process. It proactively reminds the assignees to investigate and record the results of their investigations on or before due date. It ensures that all the defined investigations or actions are performed before a complaint is closed. The system also provides real time trending and analysis of complaints received via different channels.

Spectrum Complaint is an integrated function of Spectrum Quality Platform.

Spectrum Corrective and Preventive Action (CAPA) - Overview

Spectrum Quality Platform has a comprehensive and integrated CAPA system built into the software. Because of being integrated, it has direct access to the shop floor process data at the same time without any delay or data loss. This real-time access enables to detect non-conformance with higher accuracy and send out alerts to the correct personnel for corrective action immediately and stop the ongoing issues and downstream losses. The preventive action process is invoked to avoid any similar or related issues in the future.

Spectrum CAPA is invoked upon a risk based approach. When an issue is detected, before invoking CAPA, the manufacturing team does a risk analysis to determine the severity of the issue, if CAPA invocation is needed, or further trend analysis. Any adjustments to the quality plan are required. Once CAPA is invoked, the incident is registered, and an investigation is initiated, resulting in a list of action plans. All actions are tracked till completion before the incident closure.

CAPA process is crucial to contain issues and maintain and improve the quality management system. Spectrum CAPA meets all the ISO and CFR regulatory requirements of a risk-based corrective and preventive actions system.

Spectrum Audit Management - Overview

Audit management allows you to plan, schedule, and conduct audits.

Users can conduct regulatory audits & streamline the entire audit process. The system helps organizations to standardize the audit process.

The audit module helps organizations to manage a wide range of audit-related activities, data, and processes.

It provides the flexibility to support an end to end functionality for managing the complete audit life cycle.

Effective document control can be done through this system by maintaining electronic records of documents.
The system allows the facility to manage documents, reduce paperwork, and record the various versions created and modified by different users.
Complete electronic records of document creation with the traceability of document initiation and completion details.
To ensure regulatory compliance access based approval and control is maintained within the system.

Spectrum Risk and Deviation Management - Overview

Spectrum has a systematic way of managing risk. Risk can be traceable, investigated, and addressed within the system.

Spectrum reduces the chance of risk & helps in decision–making process that may lead to risks in product quality to a greater or lesser extent.

Spectrum can handle any event & deviation that may significantly vary to standard operations, affecting the quality.

The system has the facility to investigate and take corrective actions of the identified deviation to ensure compliance-based quality practice.

Spectrum traces the OOS (out of specification) result & has the validated mechanism to be investigated and addressed.
Spectrum reduces the consequences of OOS that may result in market complaints, and rejection of commercial batches, which is an inventory loss for any pharmaceutical industry.

Investigation

Spectrum focuses on the systematic investigation of the root causes of identified problems or identified risks to prevent their recurrence (for corrective action) or prevent occurrence (for preventive action).
Spectrum ensures the concept of good manufacturing practice (GMP), risk based preventive controls and numerous ISO business standards.

Effective change management can be done and changes required to raise in any of the related disciplines can easily be maintained.
The system allows you to assess & review changes & ensure the approval and implementation of change.
Change management allows you to maintain a complete validated change control process in order to maintain the validated status of facilities, systems, equipment or processes.
The changes that have been made must follow ‘Written Procedures’ & ensure and document that the system is maintained in a validated state.

Spectrum Analytics - Overview

Spectrum has advanced analytics capabilities and dashboards for real-time or batch reporting. Spectrum dashboards are user-configurable which means that they can be customized to see metrics and graphs which are being reported according to user requirements.

Using dashboards, real-time reporting and alerting operators can focus on the most relevant issues and drill down quickly to the cause of the problems.

Through advanced SPC based analytics, operators can see if a process is within the control limits and how it will behave in the future. Process and Lab data can be queried to create reports for planning and strategizing plant and laboratory operations. The user interface and preconfigured templates enable quick report generation for internal and external audits and compliance reporting.

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