Softcom


Biotechnology

  • As bio-manufacturing uses living organisms it is very important to control the variations in production environment to maintain product quality. Biopharmaceutical processes required 5 times more testing than pharma processes needing a reliable and scalable end to end quality management solution.

  • For the last 25 years SOFCOM has been providing lab testing and process management solutions.

  • SOFCOM has created an integrated Quality Platform to track and control production processes and their testing to make sure that all procedures, policies, and corrective actions are implemented to ensure highest produce quality.

  • All upstream and downstream unit operational processes are monitored, and data gathered including media management, instrument interfacing and calibration activities.

  • Sampling and test data from in-line, on-line, at-line and off-line lab testing is gathered, tracked, and contextualized with the production process steps and feedback given to adjust critical process parameters.

  • Product quality is tracked via real time monitoring alerts, process parameter dashboards and SPC analytics.

  • Spectrum Quality Platform is a fully functional 21 CFR Part 11 compliant solution. All data from lab, production operations (LIMS & Manufacturing Execution System) and supporting systems is routed to a unified Data Lake ensuring data integrity and rapid compliance reporting.

  • The platform is built to grow with your expanding business requirements accommodating complex big data sets. The system is customer configurable for ease of use enabling custom setup and seamless operation.

  • There is full traceability of all data, equipment in use, methods, workflows, and electronic signatures allowing rapid audit capability of all laboratory processes.

  • Sophisticated analytical capabilities are provided for trend analysis, statistical calculations, predictions, and querying support.
  • Producing a quality product is the main goal of any manufacturing process. To achieve this goal activities from raw material acquisition to finished product needs to be monitored and managed at every step.

  • SPECTRUM Quality Platform has integrated laboratory information system and manufacturing execution system, along with supporting systems to gather all production processing and testing information at one place to maintain complete data integrity and a wholistic view of the entire manufacturing plant.

  • SOFCOM has created an integrated Quality Platform to track and control production processes and their testing to make sure that all procedures, policies, and corrective actions are implemented to ensure highest produce quality.

  • The integrated data lake provides a single source of truth enabling easy audits, rapid internal and external compliance reporting and reliable inter departmental communications.

  • The vendor management and reagent management systems make sure that validated vendors are supplying quality raw materials.

  • The system has built in controls to follow all methods and protocols as per regulatory and SOP guidelines.

  • SOP monitoring and alerting is very flexible and can be setup for any additional and stringent quality limits in addition to the required compliance specification for stricter quality control.

  • Spectrum Quality Platform is a fully functional 21 CFR Part 11 compliant solution implementing all the cGMP requirements.

  • In case of any issues the system supports fully functional CAPA, investigation, out of specification and complaint handling sub systems.

Case Studies
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Case Studies


Who We Are
Request for Demo
Customer Support
Case Studies






Spectrum is Available On-Premise and On-Cloud

ALL OFFERINGS


LIMS

Managing Laboratory operations and resources

Stability

Activities related to product shelf-life management

Reagents/Media Management

Managing reagents and media procurement, suppliers, inventory and forecasting

Lab Inventory Management

Lab equipment and supplies inventory management along with supplier management

Instrument Calibration

Track and manage the calibration and maintenance of instruments

Instrument & System Interfacing

Data acquisition directly from instruments to reduce errors and save time

Quality Assurance

Ensuring that the product is safe, effective, and acceptable to the customers

Manufacturing Execution System

Manage, monitor and synchronize the execution of real-time, physical processes transforming raw materials into intermediate or finished goods

Analytics

Realtime metrics, Dashboards and Statistical Process Control

Case Studies
Who We Are
Request for Demo
Customer Support

Our Clients

Adamjee Insurance Company Limited

Asian Continental (Pvt.) Limited

Atlas Autos (Pvt.) Limited

Atlas Honda Limited

ATCO Laboratories Limited

Bank AL Habib Limited

BankIslami Pakistan Limited

Bayer Pakistan (Pvt.) Limited

BF Biosciences

CCL Pharmaceuticals (Pvt.) Limited

DHL Global Forwarding Pakistan (Pvt.) Limited

Dolmen Real Estate Management (Pvt.) Limited

Drug Regulatory Authority of Pakistan

First Women Bank Limited

GlaxoSmithKline Pakistan Limited

GlaxoSmithKline Consumer Healthcare Pakistan Limited

Habib Metropolitan Bank Limited

Haleeb Foods Limited

HBZ Services (Pvt.) Limited

HBL Microfinance Bank Limited

Industrial and Commercial Bank of China Limited

Kashf Foundation

LMKR

MCB Bank Limited

Nishat Mills Limited

OBS Pakistan (Pvt.) Limited

OLP Modaraba

Pak Oman Microfinance Bank Limited

Pakistan Cables Limited

Pfizer Pakistan Limited

Pharmevo (Pvt.) Limited

Pakistan Stock Exchange Limited

Risk Associates

Saakh Pharma (Pvt.) Limited

Samba Bank Limited

Sanofi-aventis Pakistan Limited

Sapphire Fibres Limited

Sante Private Limited

Silkbank Limited

Soneri Bank Limited

Standard Chartered Bank (Pakistan) Limited

Siemens Pakistan Engineering Company Limited

Taiga Apparels

TCS (Pvt.) Limited

Techverx

Unilever Pakistan Foods Limited

Unilever Pakistan Limited

US Apparel & Textile (Pvt.) Limited

Wyeth Pakistan Limited



OUR PRODUCTS INTERESTING ANALYTICS

Employee

269428

EMPLOYEES HANDLED

Satisfied Users

17138

SATISFIED USERS

Products Inspected

10363

PRODUCTS INSPECTED
(PER MONTH)

Sample and Analysis Performed

66222

SAMPLE AND ANALYSIS PERFORMED
(PER MONTH)

Solutions that matter   



U.S. Office

Sofcom Inc.,
2100 Geng Rd,
Suite 210 Palo Alto,
CA 94303. USA.
Phone: +1 202 361 9871
Email: contact@sofcom.net

Pakistan Office

Sofcom (Private) Limited,
Sofcom House, ST-9, Block 5,
Gulshan-e-Iqbal, Karachi. 75300
Pakistan.
Phone: +92 21 3496 6991-2
Email: contact@sofcom.net

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