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Digg It - What’s Happening in Security & What You Need to Know
Security like many sectors, keeps marketing people like myself busy communicating with stakeholders about the latest issues and changes that affect them. Just as I think things are on even keel, something new appears on the horizon that needs communicating. And then it changes, so I have to communica
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
te it all again.
Confusing enough for myself, but much more of an issue for people like yourselves involved in facilities management. For most of you, security is just one of many areas you are involved with and keeping abreast with the pertinent issues that impact upon your organisation is not easy
Confusing enough for myself, but much more of an issue for people like yourselves involved in facilities management. For most of you, security is just one of many areas you are involved with and keeping abreast with the pertinent issues that impact upon your organisation is not easy
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
There are a couple of current issues that you need to be aware of. Firstly, new European Standards have recently been introduced for intruder alarm installation and secondly, there is the impact of the Private Security Industry Act 2001 on the manned security sector.
Euro Standards for Intruder
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
and Hold-up Alarms Are Here
Security is no exception to Europeanisation of Standards being negotiated into a pan-European role, EU members anyway, where ultimately everything will be the same in member states. But not quite yet.
As from October last year, the British Standard (BS 4737) for the
Security is no exception to Europeanisation of Standards being negotiated into a pan-European role, EU members anyway, where ultimately everything will be the same in member states. But not quite yet.
As from October last year, the British Standard (BS 4737) for the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
installation of intruder alarms is no more, having been replaced with the European Standard EN 50131-1. Well it’s not quite that simple. We like to be a little different in the UK and therefore new installations should be specified against a scheme document known as BSI PD 6662:2004, which is the UK
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
version for implementing EN 50131, retaining some aspects of BS 4737 because EN 50131 is incomplete.
Considered by many to be the largest transformation of the UK intruder alarms industry in 30 years, what does this mean for you? A fundamental change is that PD 6662 alarms need to be given a securi
Considered by many to be the largest transformation of the UK intruder alarms industry in 30 years, what does this mean for you? A fundamental change is that PD 6662 alarms need to be given a securi
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
y grading, with Grade 1 for the lowest and Grade 4 for the highest risk. Insurers generally state that Grade 3 equates in most respects to the majority of systems that are currently installed in commercial premises in the UK. Grade 2 systems are likely to be acceptable for most household risks and so
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
e low risk commercial premises. However, your insurer should be consulted as they are underwriting your risk and they will determine what grade of system is necessary. (When preparing tender documents, reference should be made to PD 6662 and not specifically EN 50131. To help avoid confusion, NSI rec
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mmends that its approved companies quote for PD 6662:2004 alarm systems and put additional explanatory words such as “which is the UK implementation of EN 50131”.)
On a separate issue, you should be aware that there are only two ways of receiving police response to newly installed remotely monitored
On a separate issue, you should be aware that there are only two ways of receiving police response to newly installed remotely monitored
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
electronic security systems. For intruder and hold-up alarms installed after October 2005, PD 6662 is the only way a new system can be issued with a police unique reference number (URN) in order to receive police response to confirmed alarm activations. Secondly, URN’s can also be issued for Detecto
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
Activated CCTV systems complying with BS 8418.
Manned Security & the Private Security Industry Act 2001
Voluntary regulation led by NSI and supported by the likes of insurers and police, has had a major impact in driving up standards in the electronic security sector. NSI has also achieved
Manned Security & the Private Security Industry Act 2001
Voluntary regulation led by NSI and supported by the likes of insurers and police, has had a major impact in driving up standards in the electronic security sector. NSI has also achieved
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
uch success in the manned guarding sector with the majority of UK contracts, in terms of value, being provided by NSI Guarding Gold and Silver approved companies. Outside voluntary regulation however, there remains a core of non-regulated companies, in many cases providing customers contracting secur
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ty personnel with a sub-standard service sometimes operating at a criminal level.
The Private Security Industry Act provided for the creation of the Security Industry Authority (SIA) which is empowered to introduce regulation (mandatory or voluntary as it deems fit) aimed at raising standards in man
The Private Security Industry Act provided for the creation of the Security Industry Authority (SIA) which is empowered to introduce regulation (mandatory or voluntary as it deems fit) aimed at raising standards in man
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ned security and associated areas. The first impact of this legislation on many businesses is that externally-contracted security guards must have an SIA license to operate as from 20 March 2006, otherwise, it will be illegal for them to operate and companies supplying such personnel may liable to pr
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
secution.
For various reasons, including delays in processing applications (about 20 weeks) and companies leaving it late to send in staff applications, it seems likely that thousands of contract security staff will be un-licensed from that date. This could lead to many organisations that use contra
For various reasons, including delays in processing applications (about 20 weeks) and companies leaving it late to send in staff applications, it seems likely that thousands of contract security staff will be un-licensed from that date. This could lead to many organisations that use contra
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
t manned security being disrupted as suppliers are forced to withdraw their staff until such time as the employee receives a licence.
The SIA have threatened to prosecute companies who do not immediately comply. But whether they follow-up this threat or offer leniency to companies who are obviously
The SIA have threatened to prosecute companies who do not immediately comply. But whether they follow-up this threat or offer leniency to companies who are obviously
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rying to comply remains to be seen.
The issue of new security staff being un-licenced for a period may be resolved with the introduction later of the SIA’s “Approved Contractors Scheme” (ACS), which will be a voluntary scheme for security contractors to achieve SIA approval. The final details of thi
The issue of new security staff being un-licenced for a period may be resolved with the introduction later of the SIA’s “Approved Contractors Scheme” (ACS), which will be a voluntary scheme for security contractors to achieve SIA approval. The final details of thi
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s are yet to be confirmed; however it will allow a dispensation for new staff in ACS approved companies to work without a licence whilst waiting for them to be processed.
When the ACS is finally launched, NSI is likely to be one of a number of organisations conducting the verification of application
When the ACS is finally launched, NSI is likely to be one of a number of organisations conducting the verification of application
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
on behalf of the SIA. All NSI approved Guarding companies will meet the requirements of the ACS. NSI’s own standards generally exceed those of the ACS, so rest assured that when selecting NSI approved companies, you know they meet the highest industry standards.
NSI is an independent, not-for-profi
NSI is an independent, not-for-profi
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
organisation that inspects and certificates companies installing electronic security, fire protection systems and those that provide contract manned security. For advice on issues covered in this article or if you would like further information about NSI, contact 0845 006 3003 or visit www.nsi.org.u
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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