The start of a new year is always a good time to reflect. We asked Mike Bendall, a Qualsys Director with 20+ years experience in the field, to provide a few articles on future trends, and best practice lessons in document management.
In the first in a series of articles, Mike gives his view of changing trends in document management, and the quality standards that drive compliance issues through to 2015.
Document Management systems (DMS) explained
Integral to an organisation's content environment, document management involves the acquisition, storage and recovery of information pertinent to operations.
A well-functioning document management system (DMS) generates agile document-modification while improving records' retention, security, auditing and summarisation.
Regulations and quality standards developed by professional agencies for maintaining operational/performance criterion across a wide range of enterprise/business processes motivate DMS-integrity.
The International Organisation for Standardisation generates ISO-guidelines to provide best-practice principles/procedures for quality assurance, environmental management and information security. Several ISO pertinent standards are:
- ISO-9001 Quality Standard regulates workflows producing goods and services. The benchmark for quality enterprise management, it fulfils the rigours of independent, external audits. ISO9001 applies to similar products/services of the same relative class/function, globally controlling these processes to guarantee consumer needs and expectations are satisfied.
- ISO-14001 offers worldwide standards for appropriate and safe control of enterprise processes that may negatively affect the environment through wasteful/dangerous acquisition of natural resources or excessive energy consumption. Internal audits maintain 14001-certification, ensuring these standards are upheld.
- ISO-27001 standardises practices for security of organisational information. Systematic evaluation of security risks identifies administrative priorities for managing threats to information security.
The objective is assure confidentiality, integrity, and safe-access to information.
The three guidelines generate enterprise cost savings through improved efficiency, productivity, and market-expansion, caused by reliable measures of quality-assurance, environmental-protection and data-security. I've found no evidence they will be modified through 2015.
- OHSAS-18001, the most recent certification-spec from Occupational Health and Safety Management Systems, can be aligned with ISO 9001/14001, combining quality and environmental administration with occupational health/safety protection.
I believe some augmentation of OHSAS will be made before 2015, if audits demonstrate standards need to be updated to reflect current realities for workplace health/safety management; 18001's priorities mandate ongoing improvements for employee safety.
- The Care Quality Commission (CQC) monitors all British healthcare services, supplying essential standards of quality-care and safety for venues ranging from NHS-providers to hospitals, care-establishments to patients' own homes.
All health/social caregivers must be appropriately licensed by the CQC, which implements regular service-reviews to ensure progressive British healthcare. Modifications to present standards may be enacted prior to 2016 if review deems them necessary.
- SRA (Solicitors Regulation Authority) provides the legal-services community guidelines for legal and ethical issues. Its outcome-focused regulation (OFR) flexibly ensures justice and protection for clients by departing from confining conventions of law as necessary, while supporting and monitoring of solicitors' actions and behaviours.
The SRA issues edicts affecting regulations as needed, and has already made 6 revisions to the OFR guidelines. It can be expected to modify its current regulatory stance on selected issues through 2015, if the need for further legal protection arises.
- Part-11/CFR (Code of Federal Regulations) was enacted to assure best-practice DMS-procedures through mandating replacement of paper records/signatures by electronic documentation.
A new law, CFR/Part-11 will not likely be modified through 2015, unless further workplace efficiency/productivity generated by its enactment becomes necessary.
- SOX (Sarbanes-Oxley Act) protects shareholders/general public from fraudulent corporate accounting/management (eg., Enron/WorldCom-2002)
DMS-procedures affect all electronic record-keeping/administrative functions, both internal and external. SOX may be modified through 2015 if further large-scale corporate fraud emerges.
GAMP (Good Automated Manufacturing Practice) guidelines regulate pharmaceutical companies' information/test-data accuracy, its completeness, suitability and use of reliable DMS procedural, configuration and certification practices.
GxP quality guidelines are applied to certify product-safety and dependability. GAMP changes according to updates in corporate IT and its uses.
Document Management systems are innately connected to current standards/regulations, since they are themselves published documents requiring management for consistent use administering materials, products, services, technologies, processes and systems.
It is a constantly moving envrionment; document management systems will continure to evolve to meet the standards and regulations as they transition through 2015.