In a world of cut-throat competition, the only attribute that can define success for businesses/idea is the superior quality. When it is referred to Pharma/Bio-tech/Cosmetics/Medical Devices industries, the quality can be defined by the GxPs or SOPs manufacturers intend to implement and follow throughout the lifecycle. Enroute, to ensure quality maintenance, a robust Quality Management System (QMS) is deployed. However, designing and implementing the QMS, may sometimes, require organizations to invest lot of time and money to research about global legislations and to perennially update the systems. In such scenarios organizations look for a quality QMS remediation partner.
With a comprehensive knowledge on new SOP preparation or amending/standardizing existing ones, Freyr offers the suite of QMS Remediation support services. Having an expert team with complete understanding of global compliance scenario, Freyr offers end-to-end QMS audit services that span across:
Integrated Process of multiple management systems (ISO 9001, ISO 27001 with USFDA, EMEA, MHLW)
SOP Gap Analysis
While expanding businesses to newer markets, life sciences organizations required to develop new SOPs based on the regional Regulatory requirements or should update/upgrade the existing processes to align them new demands. But prior to SOP development, it is indeed a right approach to identify the gap between processes and remediate them accordingly.
To support organization’s need to develop new SOPs or enhance the existing ones, Freyr performs SOP gap analysis and remediate effectively to fill in these gaps. Freyr proposes how to amend existing SOPs and prepare new SOPs based on which the training is planned and provided. Freyr implements the ‘train the trainers’ program to ensure the future operations unaffected.
- SOP Gap Analysis
- SOP Preparation
As the business grow, the standards to be followed or adhered will also increase. There will be times when a customer fall under so many ISO standards and required to follow each standard. In such scenarios, maintaining and following different stream of SOPs for each standard will double up the procedural complexities for companies. The need of the hour is to unify or standardize the SOPs.
Following the risk-based approach and common control framework methodologies, Freyr support organizations with integrated SOPs catering to all Regulatory requirements which they fall under. Freyr’s expert group of QMS remediation can establish process architecture by integration of multiple regulations for unified management systems (ISO 9001, ISO 27001, Medical Devices - 13485, GLP - 17025, Medical Laboratories - 15189, CAP with USFDA, EMEA, MHLW, WHO, GxP, ICH).
- Process designing
- Establishing process architecture
- SOP standardization
- Risk-based approach
- Common control framework
- Integration of multiple regulations for unified management systems
At times, organizations write the SOPs to just let go the audit. But alas, those SOPs are hardly of any use to implement. Either they aren’t followed by employees or they could make processes complex, if integrated. To avoid such situations, it is needed to rationalize the SOPs that brings some value to organizations time and resources.
Supporting organizations to come off writing SOPs to just pass through the audits, Freyr designs SOPs and rationalize them in addition to adhering with applicable regulations. Thus, to bring-in real value to the company.
- SOP preparation
- SOP Gap Analysis
SOP Reconciliation and Optimization
Though there is no set guideline, as a general practice, for every two years SOPs have to be rewritten or they need to be updated. With periodical updates or enhancements, there is a chance for quality systems changed and SOPs amended for many a times and there is even a chance for self-contradictory documents. With different formats and versions accumulate, there is always a chance for overlapping and duplication. During such times, organizations are required to showcase they are continuously monitoring the SOPs.
With a clear-cut knowledge on SOPs and quality systems, Freyr assists organizations to reconcile and optimize the SOPs, periodically. Freyr’s expert compliance team develops new SOPs and carry out incremental updates. In addition, for every two years, Freyr supports organizations to file “revised with no change” if there are no updates to be recorded.
- Clean up the junk files accumulated over the years
- Reconciles and optimizes accumulated SOPs
- Supports revised with no change filing
- Develops new SOPs
- Incremental updates
Mergers and acquisitions are an integral part of today’s business scenario. But when they take place, bringing together and managing the procedures, standards, SOPs and quality systems of both the organizations could be gruelling. In addition to aligning the existing standards, setting up SOPs for newly formed organization will be even more hectic especially when it is to come into existence within short turnaround time.
Having an expert compliance team in-house, Freyr offers end-to-end SOP integration services to analyse the gaps between both the organizations’ systems, standardize existing systems and design new SOPs if needed. Freyr experts extend full system integration support for designing seamless processes and workflows.
- Integration and management of processes post acquisitions
- SOP gap analysis
- SOP standardization
- SOP rationalization
- SOP reconciliation and optimization
- SOP integration
- Ensuring product quality, Regulatory compliance, patient safety, data integrity and security
- Experienced and practicing professionals
- Integrated process models
- Effective and compliant business processes
- Proven validation and qualification strategies
- Quick turnaround timeframes
- Significant cost savings