Softtimes IT, Engineering and Validation Services
Deliver services to clients to meet SISPQ of the end product to protect Canadian lives by meeting the regulatory requirements, quality and safety of the drugs manufactured providing our services.
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Who We Are
Softtimes IT Solutions Inc provides consulting services to pharmaceutical and biopharmaceutical industries. Our vision is to provide high level engineering and IT services to clients with successful history of delivering projects as per scheduled time frames. We provide C&Q, IQ/OQ, CSV, Process and Cleaning validation services.
Our Services
01
Engineering Services
- Equipment design
- Facility/Utilities design (PW, HWFI, WFI and AWFI)
- HVAC Services
- Cleaning (CIP) services
- Single Use Technologies
02
Automation services
- Development of URS, IQ/OQ, FS, SU/SD, and PQ protocols
- PLCs, HMI, Delta V, BMS, Pi Vision, EBR (electronic batch processing)
03
Validation Services
- Provides computer system validation (CSV) by creating and executing protocols for various systems including MES, BMS, BAS
- Implementation of CSV programs
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Provides qualification and validation services
- Commissioning and Qualification for air locks, GMP rooms, critical utilities, HVAC, equipment, process, cleaning, and sterility assurance
- Lab equipment
04
Process Validation
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Preparing process validation services in accordance with:
- Health Canada Part C, Division 2 of the Food and Drug Regulation, GUI-0029: Guide to validation – drugs and supporting activities
- US FDA 21 CFR Parts 210 & 211 – Current GMPs for Finished Dose Forms
- ANSI/ASQ Z1.4-2003
- Guidance for Industry Powder Blends and Finished Dosage Units – Stratified In-Process Dosage Unit Sampling and Assessment
- ASTM PVT Stages
- Internal company standards
- Global regulations and guidelines
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The following services will be provided:
- Developing process validation plan/strategies documents
- Executing process validation protocols
- Risk Assessments
- Preparing process validation protocols (non-sterile) and reports
- Preparing bulk hold study protocols and reports
- Training
- Addressing non-conformances related to process validation activities
- CPV (Stage 3)
- Developing SOPs
05
Cleaning Validation
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Implementing cleaning development and validation strategies for
sterile and non-sterile drug manufacturing following ASTM –
E3106-18 Standard Guide for Science-Based and Risk-Based
Cleaning Process Development and Validation, and ISPE
principles. The service we provide includes the following:
- Providing risk assessment for CIP (clean-in-place) Skids – Cross Contamination using HACCP (Hazard Analysis and Critical Control Points) approach following HACCP based risk assessment guidelines.
- Developing Cleaning Validation Plan for Sterile and non-sterile drug products
- Developing Risk Assessments for cleaning processes using ASTM and ISPE Guidelines
- Developing cleaning development/validation protocols
- Preparing final cleaning development/validation reports for approvals
- Addressing any non-conformances related to cleaning validation execution/results
- Developing equipment cleaning procedures
- Training
- Carry over limit calculations
- Developing Grouping Assessments to select the worst-case product for evaluation
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Provides validation and qualification services including the
following:
- Mapping studies
- HVAC qualification including LFH
- Room Qualification
- BMS (IQ/OQ/PQ)
- Equipment Qualification (IQ/OQ/PQ protocols)
- PW/WFI/HWFI qualification
- Compressed Air Qualification including PQ
- Trend Analysis
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Sterility Assurance: (Both Sterile and Non-Sterile)
- Develop strategies document to prevent cross-contamination
- Conduct environmental monitoring
- Writing EM reports
- Addressing any non-conformances
- Trend Analysis
Contact Us For More Information
Rthaves@gmail.com
647-869-2059